## Protocol Section
### Identification Module
**NCT ID:** NCT02157779

**Acronym:** TOTRA

**Brief Title:** Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans

**Official Title:** Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans

#### Organization Study ID Info
**ID:** D1146-R
#### Organization
**Class:** FED
**Full Name:** VA Office of Research and Development
#### Secondary ID Infos
**Domain:** VA RR&D
**ID:** Rx 001146
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2019-02-28

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-11-18

**Type:** ACTUAL

**Last Update Submit Date:** 2021-10-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-02-28

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-03-16

**Type:** ACTUAL

**Results First Submit Date:** 2020-02-26

**Results First Submit QC Date:** 2020-02-26

#### Start Date
**Date:** 2015-01-01

**Type:** ACTUAL

**Status Verified Date:** 2021-10

#### Study First Post Date
**Date:** 2014-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2014-05-06
**Study First Submit QC Date:** 2014-06-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** FED

**Name:** VA Office of Research and Development

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Excessive and poorly controlled anger is one of the most common problems experienced by war Veterans. The consequences can be severe, including increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning. Availability of effective treatments is critical to reducing the adverse effects of anger in Veterans. The investigators propose to conduct a controlled study to determine whether a cognitive behavior treatment that has been adapted for treating anger problems in Veterans of Iraq and Afghanistan results in improved outcomes compared to a supportive therapy. Results will be examined for improvement in anger, functioning, and quality of life at end of 12 weekly sessions, and at 3 and 6 months following treatment.

**Detailed Description:** Poorly controlled anger is a common problem with often devastating effects in Veterans who have served in a warzone. Adverse consequences include increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning. Recent evidence indicates that anger and aggression are likely to be problems for a significant proportion of Veterans of Iraq (Operation Iraqi Freedom, OIF; Operation New Dawn, OND) and Afghanistan (Operation Enduring Freedom, OEF). A survey of reintegration problems among 754 OEF/OIF combat Veterans receiving VA Medical care showed that anger was the most commonly reported problem, with 57% reporting increased problems in controlling anger. Despite encouraging evidence for efficacy of cognitive behavioral interventions in treating anger in civilian samples, much less is known about the efficacy of such treatments for anger problems in military personnel following exposure to war zone trauma. Promising preliminary findings for individually based cognitive behavioral treatment have been reported, and there is evidence that a group anger management treatment delivered by teleconferencing is as effective as the same treatment delivered in person, but to date there is not a single adequately powered randomized trial designed to test the efficacy of an anger treatment compared to an active control condition in Veterans. Building on findings from the investigators' randomized pilot study, the objective of the current proposal is to conduct a randomized clinical trial with sufficient statistical power to test the effectiveness of a manualized cognitive behavioral intervention (CBI) that has been adapted from an existing treatment (Anger Control Therapy; Novaco, 1994, 2001) for the treatment of anger problems in OEF/OIF/OND Veterans, compared to a manualized supportive therapy intervention (SI) control condition. Ninety OEF/OIF/OND Veterans reporting significant problems with anger will be randomized to receive 12 individual sessions of one of the two study conditions. Outcomes including measures of anger and aggression; interpersonal, social and occupational functioning; and quality of life will be assessed during and at the end of treatment and at 3 and 6 month follow-ups. Exploratory analyses will examine 1) whether a diagnosis of PTSD impacts treatment effectiveness and 2) potential mediators of treatment outcome with CBI.

### Conditions Module

**Conditions:**

- Anger Problems

**Keywords:**

- Veterans

- Anger

- Cognitive Behavioral Therapy

- Treatment

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 112

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

**Intervention Names:**

- Behavioral: Cognitive Behavioral Intervention

**Label:** Cognitive Behavioral Intervention (CBI)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

**Intervention Names:**

- Behavioral: Supportive Intervention

**Label:** Supportive Intervention (SI)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cognitive Behavioral Intervention (CBI)

**Description:** Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management

**Name:** Cognitive Behavioral Intervention

**Other Names:**

- CBI

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Supportive Intervention (SI)

**Description:** Includes individual therapy sessions using supportive and problem-solving strategies.

**Name:** Supportive Intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** The ACQ is a brief self-report measure developed to assess the frequency of negative anger-related behavioral consequences. Internal consistencies of .75 to .91 have been reported. This scale includes items not covered by the other anger measures, including for example, trouble with the law, driving recklessly, getting into an accident, damaging relationships, etc. There are 50 items; minimum and maximum Values range from 0 to 200. Higher scores means more anger.

**Measure:** Least Squares Mean Total Score on the Anger Consequences Questionnaire (ACQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

**Time Frame:** Baseline, Week 12, 3 and 6 months Post-treatment

#### Primary Outcomes

**Description:** The STAXI-2 is a revision of Spielberger's State-Trait Anger Expression Inventory (STAXI), expanded from 44 to 57 items. It is a self-report questionnaire consisting of six scales and an Anger Expression Index (AX). Scales include State Anger, Trait Anger, Anger Expression-Out, Anger Expression-In, Anger Control-Out and Anger Expression-In. The Anger Expression Index is an overall measure of the expression and control of anger based on responses to the two anger expression and the two anger control subscales. Minimum and Maximum Values range from 0 to 96, higher scores mean more anger.

**Measure:** Least Squares Mean Anger Expression Index Score on the State Trait Anger Inventory 2 (STAXI-2) Using a Repeated Measures ANCOVA Adjusted for Baseline and Time Effects

**Time Frame:** Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment

**Description:** Structured Interview that assesses verbal and physical aggressive behaviors. Minimum and Maximum Values range from 0 to no maximum, higher scores mean more anger.

**Measure:** Least Squares Mean Aggression Scale Score on the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

**Time Frame:** Baseline, Weeks 4, 8,12 (end of treatment), 3 and 6 months post-treatment

#### Secondary Outcomes

**Description:** Psychosocial functioning scales from the clinician administered Longitudinal Interval Follow-up Evaluation (LIFE) provides assessment of functioning in areas of work (employment, household, or student), various aspects of interpersonal functioning, recreation and satisfaction. The global social adjustment score is based upon a 5 point scale. Ratings are based on the past month. The psychosocial functioning ratings have been found to be of generally high reliability. Minimum and Maximum Values range from 1 to 5, higher scores mean worse functioning.

**Measure:** Least Squares Mean Global Social Adjustment Score on the Longitudinal Interval Follow-up Evaluation (LIFE) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

**Time Frame:** Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment

**Description:** Psychosocial functioning scales from the clinician administered Longitudinal Interval Follow-up Evaluation (LIFE) provides assessment of functioning in areas of work (employment, household, or student), various aspects of interpersonal functioning, recreation, satisfaction and global social adjustment. Ratings are based on the past month. The psychosocial functioning ratings have been found to be of generally high reliability. Minimum and Maximum Values for the work functioning global score range from 1 to 5, higher scores mean worse functioning.

**Measure:** Least Squares Mean Global Work Functioning Score on the Longitudinal Interval Follow-up Evaluation (LIFE) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

**Time Frame:** Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment

**Description:** The OQ is a self report measure that assesses functioning and includes three subscales: symptom distress, interpersonal relations, and social role functioning. Concurrent validity has been demonstrated in relation to internal consistency and reliability. Additionally, the OQ has been shown to be fairly stable in untreated individuals and sensitive to change in those individuals in treatment. Minimum and Maximum Values range from 0 to 180, higher scores mean worse functioning.

**Measure:** Least Squares Mean Total Score on the Outcomes Questionnaire (OQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

**Time Frame:** Baseline, 12 weeks, 3 and 6 months post-treatment

**Description:** The World Health Organization Quality of Life (WHOQOL-BREF), is 26 item self-report measure used to assess quality of life in multiple domains (i.e., physical, psychological, social, and environment). Psychometric properties suggest that the measure is valid and reliable across cultures and nations. Ratings are made on a 5 point scale. The psychological subscale, which consists of 6 items, was used in this study. Minimum and Maximum Values for the psychological domain range from 6 to 30, higher scores mean better quality of life.

**Measure:** Least Squares Mean Psychological Domain Score on the WHO Quality of Life (WHOQOL) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

**Time Frame:** Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment

**Description:** The CAPS-5 (updated for DSM-5) is a clinician administered structured interview for the assessment of DSM-5 PTSD. The CAPS has excellent reliability and validity and is widely used in PTSD treatment research. Each one of the DSM-5 PTSD symptoms is rated on a 0-4 (low to high) scale to determine symptom severity. The cutoff used to establish the presence of an individual symptom is a score of 2 or greater. Overall PTSD severity is computed by summing the totals for all items. Minimum and Maximum Values range from 0 to 80, higher scores mean higher levels of symptomatology.

**Measure:** Least Squares Mean PTSD Severity Score on the Clinician-Administered PTSD Scale (CAPS) for DSM-5 Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects

**Time Frame:** Baseline,12 weeks (end of treatment), 3 and 6 months post-treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or Female current or former member of the military (active duty, National Guard or Reserve) Deployed to Iraq or Afghanistan
* Experience trauma during deployment
* Clinically significant anger
* At least 2 additional symptoms of PTSD hyperarousal
* If on medication, no changes within prior 4 weeks

Exclusion Criteria:

* Current severe substance use disorder or prior severe substance use disorder not in remission for at least 3 months
* Current psychotic symptoms
* current Mania or Bipolar Disorder
* Current suicidal or homicidal ideation requiring hospitalization
* Any severe cognitive impairment or history of Organic Mental Disorder

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Providence

**Country:** United States

**Facility:** Providence VA Medical Center, Providence, RI

**State:** Rhode Island

**Zip:** 02908

#### Overall Officials

**Official 1:**

**Affiliation:** Providence VA Medical Center, Providence, RI

**Name:** Tracie M. Shea, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** I anticipate sharing the data, but have not yet developed a specific plan.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- CSR

**IPD Sharing:** YES

**Time Frame:** April 1 2021

### References Module

#### References

**Citation:** Shea MT, Lambert J, Reddy MK, Presseau C, Sevin E, Stout RL. Treatment of trauma related anger in operation enduring freedom, operation Iraqi freedom, and operation New Dawn veterans: Rationale and study protocol. Contemp Clin Trials Commun. 2018 Aug 24;12:26-31. doi: 10.1016/j.conctc.2018.08.011. eCollection 2018 Dec. Erratum In: Contemp Clin Trials Commun. 2020 Dec 10;20:100688.

**PMID:** 30225391

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-11-28

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 761946

- Type Abbrev: Prot_SAP

- Upload Date: 2020-02-10T11:08

- Date: 2017-09-18

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 145085

- Type Abbrev: ICF

- Upload Date: 2020-02-10T11:22

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Cognitive Behavioral Intervention

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 47

**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management.

**ID:** EG000

**Other Num at Risk:** 47

**Serious Number Affected:** 3

**Serious Number At Risk:** 47

**Title:** Cognitive Behavioral Intervention

**Group ID:** EG001

**Title:** Supportive Intervention

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 45

**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.

**ID:** EG001

**Other Num at Risk:** 45

**Serious Number Affected:** 1

**Serious Number At Risk:** 45

**Title:** Supportive Intervention

**Frequency Threshold:** 5

#### Serious Events

**Term:** Panic Attack

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Panic Attack

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 47

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 45

**Term:** Death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Cardiac attack

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 47

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 45

**Term:** Death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Veteran accidentally overdosed on cocaine and fentanyl

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (10.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 47

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 45

**Num Events:** 1

**Time Frame:** 4 years

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 47

**Group ID:** BG001

**Value:** 45

**Group ID:** BG002

**Value:** 92

**Units:** Participants

### Group

**ID:** BG000

**Title:** Cognitive Behavioral Intervention

**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management

### Group

**ID:** BG001

**Title:** Supportive Intervention

**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.11

**Value:** 35.30

#### Measurement

**Group ID:** BG001

**Spread:** 9.77

**Value:** 36.5

#### Measurement

**Group ID:** BG002

**Spread:** 9.41

**Value:** 35.90

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 46

#### Measurement

**Group ID:** BG001

**Value:** 43

#### Measurement

**Group ID:** BG002

**Value:** 89

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 19

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 40

#### Measurement

**Group ID:** BG001

**Value:** 33

#### Measurement

**Group ID:** BG002

**Value:** 73

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 42

#### Measurement

**Group ID:** BG001

**Value:** 35

#### Measurement

**Group ID:** BG002

**Value:** 77

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 27

#### Measurement

**Group ID:** BG002

**Value:** 49

**Category Title:** Full Time

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 20

**Category Title:** Part Time

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 17

**Category Title:** Unemployed

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** Retired

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 22

**Category Title:** High School Graduate/GED

#### Measurement

**Group ID:** BG000

**Value:** 30

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 54

**Category Title:** Some College/Technical School

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 11

**Category Title:** College Graduate

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** Post Graduate

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.98

**Value:** 55.67

#### Measurement

**Group ID:** BG001

**Spread:** 11.86

**Value:** 54.77

#### Measurement

**Group ID:** BG002

**Spread:** 12.39

**Value:** 55.24

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.525

**Value:** 1.335

#### Measurement

**Group ID:** BG001

**Spread:** 0.500

**Value:** 1.396

#### Measurement

**Group ID:** BG002

**Spread:** 0.511

**Value:** 1.365

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.54

**Value:** 3.57

#### Measurement

**Group ID:** BG001

**Spread:** 0.71

**Value:** 3.64

#### Measurement

**Group ID:** BG002

**Spread:** 0.63

**Value:** 3.61

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.22

**Value:** 3.17

#### Measurement

**Group ID:** BG001

**Spread:** 1.08

**Value:** 2.98

#### Measurement

**Group ID:** BG002

**Spread:** 1.15

**Value:** 3.08

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 26.50

**Value:** 82.45

#### Measurement

**Group ID:** BG001

**Spread:** 22.93

**Value:** 88.31

#### Measurement

**Group ID:** BG002

**Spread:** 24.86

**Value:** 85.32

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 3.17

**Value:** 11.54

#### Measurement

**Group ID:** BG001

**Spread:** 2.61

**Value:** 10.97

#### Measurement

**Group ID:** BG002

**Spread:** 2.91

**Value:** 11.26

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.62

**Value:** 30.02

#### Measurement

**Group ID:** BG001

**Spread:** 9.52

**Value:** 32.38

#### Measurement

**Group ID:** BG002

**Spread:** 10.11

**Value:** 31.17

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Employment Status
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Education
**Unit of Measure:** Participants
### Measure 7
**Description:** STAXI-2 is a self-report questionnaire consisting of six scales and an Anger Expression Index. The Anger Expression Index is an overall measure of the expression and control of anger based on responses to two anger expression and two anger control subscales. Score range is 0 to 96; higher scores means more anger.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** State Trait Anger Inventory 2 (STAXI-2) Anger Expression Index Score
**Unit of Measure:** units on a scale
### Measure 8
**Description:** Structured Interview that assesses verbal and physical aggressive behaviors. Four subscores are calculated by multiplying frequency by severity of specific behaviors within that category. Subscores are also weighted for severity. The Aggression Scale Score is the total of subscores. Minimum score is zero; no maximum score specified as scores are determined by unlimited frequency counts of behavior. Higher scores indicate more frequent and severe aggressive behaviors.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Overt Anger Scale-Modified Aggression Scale
**Unit of Measure:** units on a scale
### Measure 9
**Description:** LIFE psychosocial functioning scales assess functioning in multiple areas, including work, interpersonal relationships, recreation, and global social adjustment. The global social adjustment score ranges from 1 to 5, with higher scores reflecting poorer functioning.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Longitudinal Interval Follow up (LIFE) social functioning global score
**Unit of Measure:** units on a scale
### Measure 10
**Description:** The LIFE Work Functioning Score assess functioning in work (employment, household, or student). The work global score ranges from 1 to 5; higher scores indicate worse functioning.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** LIFE Work Functioning Global Score
**Unit of Measure:** units on a scale
### Measure 11
**Description:** The Outcomes questionnaire is a self report measure that assesses functioning and includes three subscales: symptom distress, interpersonal relations, and social role functioning. The total score is the sum of the scores for the three scales. Total scores can range from 0 to 180; higher scores mean worse functioning.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Outcomes Questionnaire
**Unit of Measure:** units on a scale
### Measure 12
**Description:** The WHOQOL is a 26 item self report measure used to assess quality of life in multiple domains. The psychological domain includes 6 items, each rated on a scale from 1 to 5. The score is obtained by computing the means of each item of the scale, and multiplying the mean by 4. Scores can range from 4 to 20. Higher scores reflect better quality of life.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** WHO Quality of Life (WHOQOL) Psychological Domain
**Unit of Measure:** units on a scale
### Measure 13
**Description:** The CAPS-5 is a clinician administered structured interview assessing the DSM-5 PTSD symptoms. Each of the 20 symptoms is rated on a 0 to 4 scale; the range for the total score is 0 to 80. Higher scores reflect more severe PTSD.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Clinician Administered PTSD Scale (CAPS)
**Unit of Measure:** units on a scale
**Population Description:** Number of participants varies slightly for some measures due to missing data.
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** MaryTracie.Shea@va.gov
**Organization:** Providence VA Medical Center
**Phone:** 401-273-7100
**Phone Extension:** 6248
**Title:** M. Tracie Shea, PhD
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -10.32
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -1.01
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were used in the HLM analyses.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** .017
**P-Value Comment:** Threshold for statistical significance was 0.025.
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -5.68
**Statistical Comment:** Method used: Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -0.33
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.06
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Population Description: All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were used in the statistical analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**P-Value:** 0.19
**P-Value Comment:** The threshold for statistical significance was p=0.025
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -0.14
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -0.75
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.09
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Population Description: All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**P-Value:** .011
**P-Value Comment:** Threshold for statistical significance was 0.025.
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -0.42
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -0.63
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.11
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment, 3 month and/or 6 month follow-up) were included in the analyses.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.16
**P-Value Comment:** Threshold for statistical significance was 0.025.
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -0.26
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -22.20
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -1.09
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment), 3 month and/or 6 month follow-up) were included in the statistical analyses.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** .031
**P-Value Comment:** Threshold for statistical significance was 0.025.
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -11.65
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 0.51
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.60
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** All randomized participants with at least one post-baseline assessment (week 12 (end of treatment), 3 month, and/or 6 month follow-up) were used in the statistical analysis.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.
**P-Value:** 0.004
**P-Value Comment:** Threshold for statistical significance was 0.025.
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** 1.56
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** -7.37
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.07
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI
**Group Description:** All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.416
**P-Value Comment:** Threshold for statistical significance was 0.025.
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -2.15
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** -25.94
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -1.50
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment were used in the analyses.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.028
**P-Value Comment:** Threshold for significance was 0.025
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -13.72
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance controlling for baseline score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** All randomized participants with at least one DAR completed in each time frame (sessions 1-4, 5-8, and 9-12) were included in the analyses. The mean DAR scores for sessions 1-4, 5-8, and 9-12 were calculated and used as outcome variables in the GLM repeated measures ANOVA.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.13
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** GLM Repeated Measures Analysis of Variance of means grouped by sessions 1-4, 5-8, and 9-12
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
### Outcome Measure 10
#### Analysis
**CI Lower Limit:** -1.578
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.063
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (week 4, week 8, week 12 (end of treatment), 3 mo and/or 6 month follow-up) were included in the HLM analyses.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.030
**P-Value Comment:** Threshold for statistical significance was 0.025.
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -0.82
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 11
#### Analysis
**CI Lower Limit:** -0.158
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.011
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.

Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.021
**P-Value Comment:** Threshold for statistical significance was 0.025.
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -0.085
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 12
#### Analysis
**CI Lower Limit:** -0.283
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.073
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were used in the HLM analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.246
**P-Value Comment:** Threshold for significance was 0.025
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -0.10
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 13
#### Analysis
**CI Lower Limit:** -0.27
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.01
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment were used in the statistical analysis. Data were winsorized and log 10 transformed to counter high levels of skewness.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.036
**P-Value Comment:** Threshold for statistical significance was 0.025.
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -0.14
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 14
#### Analysis
**CI Lower Limit:** -0.213
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.1614
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.

Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.786
**P-Value Comment:** Threshold for statistical significance was 0.025
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -0.026
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 15
#### Analysis
**CI Lower Limit:** -0.18
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.13
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.

Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.744
**P-Value Comment:** Threshold for significance was 0.025.
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -0.02
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 16
#### Analysis
**CI Lower Limit:** -3.038
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.663
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.002
**P-Value Comment:** Threshold for significance was 0.025
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -1.85
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 17
#### Analysis
**CI Lower Limit:** -2.518
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.524
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.186
**P-Value Comment:** Threshold for significance was 0.025
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -1.0
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 18
#### Analysis
**CI Lower Limit:** -0.560
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.09
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.

Full Information Maximum Likelihood was used to account for missing data.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.164
**P-Value Comment:** Threshold for significance was 0.025
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** 1.26
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 19
#### Analysis
**CI Lower Limit:** -0.26
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.92
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.

Full Information Maximum Likelihood was used to account for missing data.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.100
**P-Value Comment:** Threshold for statistical significance was 0.025.
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** 1.33
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 20
#### Analysis
**CI Lower Limit:** -12.85
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.27
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.

Full Information Maximum Likelihood was used to account for missing data.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI, indicating less symptomatic distress.
**P-Value:** 0.060
**P-Value Comment:** Threshold for significance was 0.025
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -6.29
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 21
#### Analysis
**CI Lower Limit:** -6.083
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.458
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.

Full Information Maximum Likelihood was used to account for missing data.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.023
**P-Value Comment:** Threshold for significance was 0.025
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -3.271
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 22
#### Analysis
**CI Lower Limit:** -3.39
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.82
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.
**Group Description:** All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.

Full Information Maximum Likelihood was used to account for missing data.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.23
**P-Value Comment:** Threshold for significance was 0.025
**Parameter Type:** Least Squares Mean Difference
**Parameter Value:** -1.28
**Statistical Comment:** Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.77
- **Upper Limit:** 
- **Value:** 41.42
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.65
- **Upper Limit:** 
- **Value:** 47.09
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.08
- **Upper Limit:** 
- **Value:** 1.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.07
- **Upper Limit:** 
- **Value:** 1.14
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.13
- **Upper Limit:** 
- **Value:** 2.85
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.10
- **Upper Limit:** 
- **Value:** 3.28
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.14
- **Upper Limit:** 
- **Value:** 2.78
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.12
- **Upper Limit:** 
- **Value:** 3.04
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.11
- **Upper Limit:** 
- **Value:** 60.69
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.27
- **Upper Limit:** 
- **Value:** 72.34
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.40
- **Upper Limit:** 
- **Value:** 13.64
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.33
- **Upper Limit:** 
- **Value:** 12.09
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.01
- **Upper Limit:** 
- **Value:** 22.56
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.69
- **Upper Limit:** 
- **Value:** 24.71
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.71
- **Upper Limit:** 
- **Value:** 30.48
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.75
- **Upper Limit:** 
- **Value:** 44.20
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.91
- **Upper Limit:** 
- **Value:** 14.35
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.65
- **Upper Limit:** 
- **Value:** 15.43
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.77
- **Upper Limit:** 
- **Value:** 10.76
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.99
- **Upper Limit:** 
- **Value:** 12.96
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.80
- **Upper Limit:** 
- **Value:** 8.60
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.53
- **Upper Limit:** 
- **Value:** 11.88
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.29
- **Upper Limit:** 
- **Value:** 4.02
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.26
- **Upper Limit:** 
- **Value:** 4.84
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.03
- **Upper Limit:** 
- **Value:** 0.26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.02
- **Upper Limit:** 
- **Value:** 0.34
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.07
- **Upper Limit:** 
- **Value:** 0.85
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.06
- **Upper Limit:** 
- **Value:** 0.96
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.05
- **Upper Limit:** 
- **Value:** 0.19
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.04
- **Upper Limit:** 
- **Value:** 0.33
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.06
- **Upper Limit:** 
- **Value:** 0.11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.05
- **Upper Limit:** 
- **Value:** 0.14
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.06
- **Upper Limit:** 
- **Value:** 0.11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.05
- **Upper Limit:** 
- **Value:** 0.14
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.44
- **Upper Limit:** 
- **Value:** 16.42
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.41
- **Upper Limit:** 
- **Value:** 18.27
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.55
- **Upper Limit:** 
- **Value:** 18.31
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.52
- **Upper Limit:** 
- **Value:** 19.31
**Title:** 
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.68
- **Upper Limit:** 
- **Value:** 20.07
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.62
- **Upper Limit:** 
- **Value:** 18.80
**Title:** 
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.68
- **Upper Limit:** 
- **Value:** 20.71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.54
- **Upper Limit:** 
- **Value:** 19.38
**Title:** 
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.56
- **Upper Limit:** 
- **Value:** 35.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.08
- **Upper Limit:** 
- **Value:** 41.58
**Title:** 
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.09
- **Upper Limit:** 
- **Value:** 14.66
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.86
- **Upper Limit:** 
- **Value:** 17.93
**Title:** 
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.82
- **Upper Limit:** 
- **Value:** 11.39
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.67
- **Upper Limit:** 
- **Value:** 12.68
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The STAXI-2 is a revision of Spielberger's State-Trait Anger Expression Inventory (STAXI), expanded from 44 to 57 items. It is a self-report questionnaire consisting of six scales and an Anger Expression Index (AX). Scales include State Anger, Trait Anger, Anger Expression-Out, Anger Expression-In, Anger Control-Out and Anger Expression-In. The Anger Expression Index is an overall measure of the expression and control of anger based on responses to the two anger expression and the two anger control subscales. Minimum and Maximum Values range from 0 to 96, higher scores mean more anger.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with one or more post-baseline assessments were included in Hierarchical Linear Model (HLM) analyses. Not all participants had post-baseline data; some treatment noncompleters had one or more post-baseline assessments. Least Square Means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment
**Title:** Least Squares Mean Anger Expression Index Score on the State Trait Anger Inventory 2 (STAXI-2) Using a Repeated Measures ANCOVA Adjusted for Baseline and Time Effects
**Type:** PRIMARY
**Unit of Measure:** score on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention (CBI)
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention (SI)
#### Outcome Measure 2
**Description:** Structured Interview that assesses verbal and physical aggressive behaviors. Minimum and Maximum Values range from 0 to no maximum, higher scores mean more anger.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Participants with at least one post-baseline measure (4wk, 8wk, 12 wk, 3 mo and/or 6 mo f/u) were included in HLM analysis. Not all participants had post-baseline data, and some non-completers had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated analyses of covariance are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks 4, 8,12 (end of treatment), 3 and 6 months post-treatment
**Title:** Least Squares Mean Aggression Scale Score on the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 3
**Description:** Psychosocial functioning scales from the clinician administered Longitudinal Interval Follow-up Evaluation (LIFE) provides assessment of functioning in areas of work (employment, household, or student), various aspects of interpersonal functioning, recreation and satisfaction. The global social adjustment score is based upon a 5 point scale. Ratings are based on the past month. The psychosocial functioning ratings have been found to be of generally high reliability. Minimum and Maximum Values range from 1 to 5, higher scores mean worse functioning.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (12 wk (end of treatment), 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment
**Title:** Least Squares Mean Global Social Adjustment Score on the Longitudinal Interval Follow-up Evaluation (LIFE) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management.
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 4
**Description:** Psychosocial functioning scales from the clinician administered Longitudinal Interval Follow-up Evaluation (LIFE) provides assessment of functioning in areas of work (employment, household, or student), various aspects of interpersonal functioning, recreation, satisfaction and global social adjustment. Ratings are based on the past month. The psychosocial functioning ratings have been found to be of generally high reliability. Minimum and Maximum Values for the work functioning global score range from 1 to 5, higher scores mean worse functioning.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (12 wk (end of treatment), 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment
**Title:** Least Squares Mean Global Work Functioning Score on the Longitudinal Interval Follow-up Evaluation (LIFE) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management.
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 5
**Description:** The OQ is a self report measure that assesses functioning and includes three subscales: symptom distress, interpersonal relations, and social role functioning. Concurrent validity has been demonstrated in relation to internal consistency and reliability. Additionally, the OQ has been shown to be fairly stable in untreated individuals and sensitive to change in those individuals in treatment. Minimum and Maximum Values range from 0 to 180, higher scores mean worse functioning.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (12 wk (end of treatment), 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks, 3 and 6 months post-treatment
**Title:** Least Squares Mean Total Score on the Outcomes Questionnaire (OQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management.
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 6
**Description:** The World Health Organization Quality of Life (WHOQOL-BREF), is 26 item self-report measure used to assess quality of life in multiple domains (i.e., physical, psychological, social, and environment). Psychometric properties suggest that the measure is valid and reliable across cultures and nations. Ratings are made on a 5 point scale. The psychological subscale, which consists of 6 items, was used in this study. Minimum and Maximum Values for the psychological domain range from 6 to 30, higher scores mean better quality of life.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (12 wk (end of treatment), 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks (end of treatment), 3 and 6 months post-treatment
**Title:** Least Squares Mean Psychological Domain Score on the WHO Quality of Life (WHOQOL) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management.
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 7
**Description:** The CAPS-5 (updated for DSM-5) is a clinician administered structured interview for the assessment of DSM-5 PTSD. The CAPS has excellent reliability and validity and is widely used in PTSD treatment research. Each one of the DSM-5 PTSD symptoms is rated on a 0-4 (low to high) scale to determine symptom severity. The cutoff used to establish the presence of an individual symptom is a score of 2 or greater. Overall PTSD severity is computed by summing the totals for all items. Minimum and Maximum Values range from 0 to 80, higher scores mean higher levels of symptomatology.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (12 wk (end of treatment), 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline,12 weeks (end of treatment), 3 and 6 months post-treatment
**Title:** Least Squares Mean PTSD Severity Score on the Clinician-Administered PTSD Scale (CAPS) for DSM-5 Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management.
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 8
**Description:** The ACQ is a brief self-report measure developed to assess the frequency of negative anger-related behavioral consequences. Internal consistencies of .75 to .91 have been reported. This scale includes items not covered by the other anger measures, including for example, trouble with the law, driving recklessly, getting into an accident, damaging relationships, etc. There are 50 items; minimum and maximum Values range from 0 to 200. Higher scores means more anger.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with one or more post-baseline assessments (week 12, 3- and/or 6-month follow-up) were included in HLM analyses. Not all participants had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 12, 3 and 6 months Post-treatment
**Title:** Least Squares Mean Total Score on the Anger Consequences Questionnaire (ACQ) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** score on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention (CBI)
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention (SI)
#### Outcome Measure 9
**Description:** The DAR is a 7 item self-report measure of anger reactions. It has been found to be reliable and sensitive to change. Higher scores reflect more severe anger. Scores can range from 0 to 28.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Participants with at one or more DARs completed during each of the time frames (sessions 1-4, 5-8, 9-12) were included in the analyses. Not all randomized participants had one or more DARs in all time frames. Some who did not complete treatment did have at least one DAR in all time frames.
**Reporting Status:** POSTED
**Time Frame:** The DAR was administered at each weekly 75-minute treatment session (up to 12 sessions). The mean DAR scores for sessions 1-4, 5-8, and 9-12 were calculated and used as outcome variables in the GLM repeated measures ANOVA.
**Title:** Mean Scores for Sessions 1-4, 5-8, and 9-12 on the Dimensions of Anger Response (DAR) Measure Using a Generalized Linear Model (GLM) Repeated Measures ANOVA
**Type:** POST_HOC
**Unit of Measure:** score on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 10
**Description:** The OAS-M is a structured Interview that assesses verbal and physical aggressive behaviors. The Global Anger and Aggression Score consists of two items - subjective experience and overt expression of anger, each rated on a scale from 0 to 5. Minimum and Maximum Values range from 0 to 10, higher scores means more anger.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to the CBI or SI. Those with at least one post-baseline measure (4wk, 8wk, 12 wk, 3 mo and/or 6 mo f/u) were included in HLM analysis. . Not all participants had post-baseline data, and some non-completers had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated analyses of covariance are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment
**Title:** Least Squares Mean Global Anger and Aggression Score on the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** POST_HOC
**Unit of Measure:** score on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 11
**Description:** The OAS-M is a structured Interview that assesses verbal and physical aggressive behaviors. Aggressive Outbursts is a measure of the frequency and severity of all aggressive outbursts over the past week.Minimum and Maximum Values range from 0 to no maximum, higher scores means more anger.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Participants with at least one post-baseline measure (4wk, 8wk, 12 wk, 3 mo and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment
**Title:** Least Squares Mean Aggressive Outbursts Score From the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** POST_HOC
**Unit of Measure:** units on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 12
**Description:** The OAS-M is a structured interview that assesses frequency of anger and aggression. The verbal assault subscale measures the frequency and severity of verbal assaults over the previous week. Minimum and Maximum Values range from 0 to no maximum, higher scores means more anger.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (12 wk (end of treatment), 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 month and 6 month follow-ups
**Title:** Least Squares Mean Verbal Assault Score on the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** POST_HOC
**Unit of Measure:** units on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 13
**Description:** The OAS-M is a structured interview that assesses anger and aggressive behaviors. The Assaults on Objects Subscale assesses the frequency and severity of assaults against objects over the past week. Minimum and Maximum Values range from 0 to no maximum, higher scores means more assaults.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (12 wk (end of treatment), 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment follow-ups
**Title:** Least Squares Mean Assaults on Objects Score on the Overt Aggression Scale-Modified (OAS-M) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** POST_HOC
**Unit of Measure:** units on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 14
**Description:** The Assault Against Others Subscale assesses the frequency and severity of aggressive behaviors towards others. Minimum and Maximum Values range from 0 to no maximum, higher scores means more anger.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (12 wk (end of treatment), 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment
**Title:** Least Squares Mean Assault Against Others Score on the Overt Aggression Scale-Modified Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** POST_HOC
**Unit of Measure:** units on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 15
**Description:** The OAS-M is a structured interview assessing anger and aggression. The Assault against Self Subscale assesses the frequency and severity of aggression towards oneself during the past week. Minimum and Maximum Values range from 0 to no maximum, higher scores means more anger.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were included in the analyses. Data were winsorized and log 10 transformed to counter high levels of skewness. Least Square means and differences adjusted for baseline and time effects from repeated analyses of covariance are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, weeks 4, 8, 12 (posttreatment), 3 and 6 months posttreatment
**Title:** Least Squares Mean Assault Against Self Scale on the Overt Aggression Scale-Modified Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** POST_HOC
**Unit of Measure:** units on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 16
**Description:** The revised STAXI-2 is a 57 item self-report questionnaire that consists of five subscales and an anger expression index. The Anger Expression Out (AX-O) subscale measures how often angry feelings are expressed in verbally or physically aggressive behavior. It consists of 8 items, with a subscale range of 8 to 32. Higher scores indicate higher levels of expressed anger.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (4 wk, 8wk,12 wk (end of tx), 3 mo and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment
**Title:** Least Squares Mean Anger Expression Out Scale Score on the State Trait Anger Inventory 2 (STAXI-2) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** POST_HOC
**Unit of Measure:** score on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 17
**Description:** The revised STAXI-2 is a 57 item self-report questionnaire that consists of five subscales and an anger expression index. The Anger Expression In subscale measures how often angry feelings are experienced but not expressed (suppressed). It consists of 8 items with a score range of 8-32. Higher scores indicate higher levels of experienced anger.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (4 wk, 8 wk, 12 wk (posttreatment), 3 mo and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline measures. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment
**Title:** Least Squares Mean Anger Expression Scale Score on the State-Trait Anger Inventory Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** POST_HOC
**Unit of Measure:** score on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 18
**Description:** The STAXI-2 Anger Control Out subscale measures how often a person controls the outward expression of angry feelings. It consists of 8 items with a score range of 8 to 32. Higher scores reflect more effort in monitoring and preventing the outward expression of anger.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (posttreatment), 3 mo and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline measures. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment
**Title:** Least Squares Mean Score on the Anger Control Out Scale From the State Trait Anger Inventory-2 (STAXI-2) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** POST_HOC
**Unit of Measure:** score on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 19
**Description:** The STAXI-2 Anger Control-In subscale measures how often a person attempts to control angry feelings by calming down or cooling off. It has 8 items with a score range of 8 to 32. Higher scores indicate more frequent attempts to control internal experiences of anger.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with at least one post-baseline measure (4 wk, 8 wk, 12 wk (posttreatment), 3 mo and/or 6 mo f/u) were included in HLM analysis. Not all had post-baseline data, and some who didn't complete treatment had one or more post-baseline measures. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data
**Reporting Status:** POSTED
**Time Frame:** Baseline, weeks 4, 8, 12 (post-treatment), 3 and 6 month post-treatment
**Title:** Least Squares Mean Anger Control-In Score on the State-Trait Anger Expression Inventory-2 (STAXI-2) Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** POST_HOC
**Unit of Measure:** score on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 20
**Description:** The Symptom Distress subscale assesses symptoms of affective disorders, anxiety disorders, adjustment disorders and stress related illness. It consists of 25 items, with a score range from 0 to 100. Higher scores indicate more symptoms and distress.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with one or more post-baseline assessments (wk 12, 3- and/or 6-mo follow-up) were included in HLM analyses. Not all participants had post-baseline data, and some who didn't complete treatment had one or more post-baseline measures. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, week 12 (end of treatment), 3 and 6 months post-treatment
**Title:** Least Squares Mean Symptom Distress Score on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** POST_HOC
**Unit of Measure:** score on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 21
**Description:** The OQ Interpersonal Relations subscale assesses complaints such as loneliness, conflicts with others, family and marriage problems. High scores reflect more difficulties in these areas. This subscale contains 11 items with a range of 0 to 44.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with one or more post-baseline assessments (week 12, 3- and/or 6-month follow-up) were included in HLM analyses. Not all participants had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 12 (End of Treatment), 3 and 6 months post-treatment
**Title:** Least Squares Mean Interpersonal Relations Scale Score on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** POST_HOC
**Unit of Measure:** score on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
#### Outcome Measure 22
**Description:** The Social Role scale measures the extent to which difficulties in the social roles of worker, homemaker, or student are present. This subscale contains 9 items with a range of 0 to 36. Higher scores indicate more conflicts at work, overwork, distress, and inefficiency in these roles.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants were randomly assigned to CBI or SI. Those with one or more post-baseline assessments (week 12, 3- and/or 6-month follow-up) were included in HLM analyses. Not all participants had post-baseline data, and some who didn't complete treatment had one or more post-baseline assessments. Least Square means and differences adjusted for baseline and time effects from repeated measures ANCOVA are shown. Full Information Maximum Likelihood was used to account for missing data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 12 (End of Treatment), 3 and 6 months post-treatment.
**Title:** Mean Social Role Scale on the Outcomes Questionnaire Using a Repeated Measures ANCOVA Adjusted for Baseline Scores and Time Effects
**Type:** POST_HOC
**Unit of Measure:** units on a scale
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** OG000
**Title:** Cognitive Behavioral Intervention
##### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** OG001
**Title:** Supportive Intervention
### Participant Flow Module
#### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, and cognitive and behavioral anger management strategies

Cognitive Behavioral Intervention: Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
**ID:** FG000
**Title:** Cognitive Behavioral Intervention
#### Group
**Description:** 12 weekly individual sessions consisting of psychoeducation, problem-solving strategies, and support

Supportive Intervention: Includes individual therapy sessions using supportive and problem-solving strategies.
**ID:** FG001
**Title:** Supportive Intervention
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Logistical
###### Reason
**Group ID:** FG000
**Number of Subjects:** 9
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Withdraw
**Type:** Stopped attending, reason unknown
###### Reason
**Group ID:** FG000
**Number of Subjects:** 11
###### Reason
**Group ID:** FG001
**Number of Subjects:** 7
##### Withdraw
**Type:** No response to outreach after Baseline
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Moved
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Medical
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Legal issue
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 47
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 45
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 23
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 34
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 24
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 11
**Pre-Assignment Details:** Of the 112 enrolled, 94 completed both the first and second baseline assessments and were deemed eligible for the study. Of the 94 who completed their second baseline and were deemed eligible for the study, 92 were randomized to treatment. Two of the 92 randomized participants did not respond to outreach and did not start treatment.
**Recruitment Details:** Participants were recruited from a wide range of sources during the time period of January 1, 2015 through January 31, 2018. The primary recruitment source was the Providence Veterans Affairs Medical Center, including the OEF/OIF specialty primary care clinic, the Returning Veterans Outreach Program (REVOC) and the PTSD Clinic.
**Has Results:** True