## Protocol Section
### Identification Module
**NCT ID:** NCT01921179

**Brief Title:** Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI

**Official Title:** Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI

#### Organization Study ID Info
**ID:** D1111-I
#### Organization
**Class:** FED
**Full Name:** VA Office of Research and Development
### Status Module
#### Completion Date
**Date:** 2018-12-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-02-17

**Type:** ACTUAL

**Last Update Submit Date:** 2020-02-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-12-30

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-02-17

**Type:** ACTUAL

**Results First Submit Date:** 2020-01-17

**Results First Submit QC Date:** 2020-02-03

#### Start Date
**Date:** 2013-07-31

**Type:** ACTUAL

**Status Verified Date:** 2020-02

#### Study First Post Date
**Date:** 2013-08-13
**Type:** ESTIMATED
**Study First Submit Date:** 2013-08-02
**Study First Submit QC Date:** 2013-08-08
### 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:** One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with concurrent mild TBI and PTSD. One purpose of this study is to learn more about how PTSD and mild brain injury influences how people think, act, and feel. This may include how people pay attention, keep information in memory, organize plans for achieving important goals, and manage stress. Another purpose of this research is to learn more about the effects of cognitive training on the thinking, behavior, and emotions of individuals with PTSD and mild brain injury - both in the short- and long-term. With this research, the investigators hope to better understand and treat cognitive and emotional difficulties that can occur due to PTSD and mild brain injury.

**Detailed Description:** The overall aim of this proposal is to investigate the potential short and long term effectiveness of a cognitive training program Goal-Oriented Attentional Self-regulation (GOALS) that targets executive control functions in Veterans with co-morbid posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (mTBI), and cognitive difficulties. Both PTSD and a history of mild TBI are prevalent in Veterans from the Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) conflicts, with reported rates for each disorder ranging from 14 - 22%. Both PTSD and TBI have been associated with cognitive dysfunction which may lead to functional impairment and poor community reintegration. PTSD can be highly debilitating not only due to emotional dysregulation, but also due to deficits in the cognitive control processes.

Goal-Oriented Attentional Self-Regulation (GOALS) is a therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and goal management, and links them to participant-defined real-life goals. In a prior study with individuals with chronic brain injury, this training has improved cognitive performance in areas of complex attention / executive function, memory, complex functional task performance, and daily functioning. Furthermore, functional MRI results after training indicated significantly enhanced modulation of neural processing in extrastriate cortex and changes in prefrontal cortex. Preliminary results from a recently completed study with Veterans with a history of chronic TBI also support improvements post GOALS on neuropsychological measures of attention and executive function, performance on complex 'real-life' tasks, and self-report measures of functional performance. Furthermore, participants also showed improvement on the emotional regulation self-report measures. These findings suggest that improving cognitive control may also improve functioning in other domains such as emotional regulation and functional performance in daily life.

In a randomized, controlled intervention study design, 42 Veterans with a diagnosis of PTSD, history of mTBI and residual cognitive difficulties will participate in experimental (GOALS), and/or active comparison (Brain Health Education - EDU) interventions matched for time and intensity. Participants will be randomized to start with either 5 weeks of GOALS or EDU training. Those who begin with EDU will cross-over to GOALS, while those begin with GOALS will have 5 weeks of self-driven practice only. Both groups will participate in pre and post intervention measurements at baseline, weeks 5 and 10. Long-term follow-up will be at 6 months. Pre- and post-intervention measurements will include performance on untrained: neuro-cognitive tests assessing targeted and non-targeted cognitive domains, complex functional task performance in low structure 'real-world' setting, and self-report measures of emotional regulation and daily functioning.

### Conditions Module

**Conditions:**

- Post Traumatic Stress Disorder

- Mild Traumatic Brain Injury, Concussion

**Keywords:**

- Post Traumatic Stress Disorder,

- Mild Traumatic Brain Injury

- Concussion

- Cognitive Rehabilitation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 76

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Goal-Oriented Attentional Regulation (GOALS) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). Some subjects will only receive the GOALS intervention.

**Intervention Names:**

- Behavioral: GOALS (Goal-Oriented Attentional Regulation)

**Label:** GOALS (Goal-Oriented Attentional Regulation)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.

**Intervention Names:**

- Behavioral: EDU (Brain Health Education)

**Label:** EDU (Brain Health Education)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- GOALS (Goal-Oriented Attentional Regulation)

**Description:** Goal-Oriented Attentional Regulation (GOALS) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). Some subjects will only receive the GOALS intervention.

**Name:** GOALS (Goal-Oriented Attentional Regulation)

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- EDU (Brain Health Education)

**Description:** Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.

**Name:** EDU (Brain Health Education)

**Other Names:**

- EDU

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching.

(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)

**Measure:** Change in Performance on Neurocognitive Measure of Attention and Executive Function Post GOALS Intervention vs EDU Control Training

**Time Frame:** baseline, 5 weeks

**Description:** Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching.

(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)

**Measure:** Long Term Follow-up After GOALS Training - Change in Performance on Neurocognitive Measures of Attention and Executive Function 6+ Months Post GOALS Intervention Relative to Baseline

**Time Frame:** baseline, 6+ months after GOALS training

#### Secondary Outcomes

**Description:** Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome.

**Measure:** Change in Performance on Complex Functional Task -Goal Processing Scale Post GOALS Intervention vs EDU Control Training

**Time Frame:** baseline; 5 weeks

**Description:** Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome

**Measure:** Long Term Follow-up After GOALS Training - Change in Performance on Complex Functional Task -Goal Processing Scale 6+ Months Post GOALS Intervention Relative to Baseline

**Time Frame:** baseline, 6 months post GOALS training

**Description:** Overall psychological distress will be assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure).

(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)

**Measure:** Change on Self Report Measures of Emotional Regulation GOALS Post Intervention vs EDU Control Training

**Time Frame:** baseline, 5 weeks

**Description:** Overall psychological distress is assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure)

(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)

**Measure:** Long Term Follow-up Change on Self Report Measures of Emotional Regulation 6+ Months Post GOALS Intervention

**Time Frame:** baseline, 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosis of PTSD
* History of mild TBI, including concussion \> 6 months ago
* Cognitive difficulties affecting daily functioning
* Age 18-75
* Veteran
* At least 12th grade education or equivalent

Exclusion Criteria:

* Amnesic/Severe memory problems
* Active Substance Abuse/Dependence
* Medical condition that may affect mental status/disrupt study participation
* Active psychotropic medication changes
* Participation in evidence-based PTSD treatment

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Martinez

**Country:** United States

**Facility:** Martinez Outpatient Clinic and Community Living Center, Martinez, CA

**State:** California

**Zip:** 94553

**Location 2:**

**City:** San Francisco

**Country:** United States

**Facility:** San Francisco VA Medical Center, San Francisco, CA

**State:** California

**Zip:** 94121

#### Overall Officials

**Official 1:**

**Affiliation:** San Francisco VA Medical Center, San Francisco, CA

**Name:** Tatjana Novakovic-Agopian, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Following study completion and publication of results we will explore available mechanisms for data sharing

**IPD Sharing:** YES

### References Module

#### References

**Citation:** Novakovic-Agopian T, Chen AJ, Rome S, Abrams G, Castelli H, Rossi A, McKim R, Hills N, D'Esposito M. Rehabilitation of executive functioning with training in attention regulation applied to individually defined goals: a pilot study bridging theory, assessment, and treatment. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):325-38. doi: 10.1097/HTR.0b013e3181f1ead2.

**PMID:** 21169860

**Citation:** Chen AJ, Novakovic-Agopian T, Nycum TJ, Song S, Turner GR, Hills NK, Rome S, Abrams GM, D'Esposito M. Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. Brain. 2011 May;134(Pt 5):1541-54. doi: 10.1093/brain/awr067. Epub 2011 Apr 22.

**PMID:** 21515904

**Citation:** Novakovic-Agopian T, Chen AJ, Rome S, Rossi A, Abrams G, D'Esposito M, Turner G, McKim R, Muir J, Hills N, Kennedy C, Garfinkle J, Murphy M, Binder D, Castelli H. Assessment of subcomponents of executive functioning in ecologically valid settings: the goal processing scale. J Head Trauma Rehabil. 2014 Mar-Apr;29(2):136-46. doi: 10.1097/HTR.0b013e3182691b15.

**PMID:** 23076096

**Citation:** Novakovic-Agopian T, Kornblith E, Abrams G, Burciaga-Rosales J, Loya F, D'Esposito M, Chen AJW. Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury. J Neurotrauma. 2018 Dec 1;35(23):2784-2795. doi: 10.1089/neu.2017.5529. Epub 2018 Jul 23.

**PMID:** 29717652

## Document Section

### Large Document Module

#### Large Docs

- Date: 2014-11-13

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan: Full Protocol

- Size: 328202

- Type Abbrev: Prot_SAP

- Upload Date: 2019-12-29T04:19

- Date: 2014-11-18

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 134593

- Type Abbrev: ICF

- Upload Date: 2019-12-29T04:21

- Date: 2019-03-26

- Filename: Prot_002.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol: Study Protocol Summary Abstract

- Size: 169321

- Type Abbrev: Prot

- Upload Date: 2019-12-29T04:23

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006259

- Term: Craniocerebral Trauma

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000016489

- Term: Head Injuries, Closed

- ID: D000014949

- Term: Wounds, Nonpenetrating

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M16103

- Name: Stress Disorders, Post-Traumatic

- Relevance: HIGH

- As Found: Post Traumatic Stress Disorder

- ID: M5207

- Name: Brain Injuries

- Relevance: HIGH

- As Found: Brain Injury

- ID: M628

- Name: Brain Injuries, Traumatic

- Relevance: HIGH

- As Found: Traumatic Brain Injury

- ID: M24916

- Name: Stress Disorders, Traumatic

- Relevance: HIGH

- As Found: Traumatic Stress Disorder

- ID: M5201

- Name: Brain Concussion

- Relevance: HIGH

- As Found: Mild Traumatic Brain Injury

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M9349

- Name: Craniocerebral Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M18892

- Name: Head Injuries, Closed

- Relevance: LOW

- As Found: Unknown

- ID: M17687

- Name: Wounds, Nonpenetrating

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001930

- Term: Brain Injuries

- ID: D000070642

- Term: Brain Injuries, Traumatic

- ID: D000001924

- Term: Brain Concussion

- ID: D000040921

- Term: Stress Disorders, Traumatic

- ID: D000013313

- Term: Stress Disorders, Post-Traumatic

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Potential risks were minimal. The research procedures involved presented no physical risk and minimal psychological risk to the subjects. The primary risk was the potential for anxiety or boredom associated with completing behavioral assessments and training interventions.

#### Event Groups

**Group ID:** EG000

**Title:** GOALS (Goal-Oriented Attentional Regulation)

**Deaths Num At Risk:** 37

**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.

**ID:** EG000

**Other Num at Risk:** 37

**Serious Number At Risk:** 37

**Title:** GOALS (Goal-Oriented Attentional Regulation)

**Group ID:** EG001

**Title:** EDU (Brain Health Education)

**Deaths Num At Risk:** 22

**Description:** Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training , 3 hours of individual training ,and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework.

Some subjects who completed EDU training during the randomized phase, completed the additional 5 weeks of GOALS.

**ID:** EG001

**Other Num at Risk:** 22

**Serious Number At Risk:** 22

**Title:** EDU (Brain Health Education)

**Frequency Threshold:** 1

**Time Frame:** baseline to 6 month follow-up

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 21

**Group ID:** BG001

**Value:** 19

**Group ID:** BG002

**Value:** 40

**Units:** Participants

### Group

**ID:** BG000

**Title:** GOALS (Goal-Oriented Attentional Regulation)

**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice.

Participants randomized to GOALS intervention, did no receive EDU training after completion of GOALS.

### Group

**ID:** BG001

**Title:** EDU (Brain Health Education)

**Description:** Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training , 3 hours of individual training ,and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework.

Some subjects who completed EDU training during the randomized phase, completed additional 5 weeks of GOALS training.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13.95

**Value:** 42.1

#### Measurement

**Group ID:** BG001

**Spread:** 14.86

**Value:** 47.53

#### Measurement

**Group ID:** BG002

**Spread:** 14.74

**Value:** 45.08

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 35

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

**Class Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Class Title:** Native Hawaiian or Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

**Class Title:** Black

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 28

**Class Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Class Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Class Title:** Hispanic or Latino

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 19

#### Measurement

**Group ID:** BG002

**Value:** 40

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.72

**Value:** -0.39

#### Measurement

**Group ID:** BG001

**Spread:** 0.77

**Value:** -0.38

#### Measurement

**Group ID:** BG002

**Spread:** 0.72

**Value:** -0.39

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.48

**Value:** 7.17

#### Measurement

**Group ID:** BG001

**Spread:** 1.44

**Value:** 7.31

#### Measurement

**Group ID:** BG002

**Spread:** 1.39

**Value:** 7.27

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.57

**Value:** -1.69

#### Measurement

**Group ID:** BG001

**Spread:** 1.06

**Value:** -1.94

#### Measurement

**Group ID:** BG002

**Spread:** 1.34

**Value:** -1.81

**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:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
### Measure 5
**Description:** Attention and Executive Function Overall Domain Z Score is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching.

(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Attention/Executive Function Overall Z Score
**Unit of Measure:** z score
### Measure 6
**Description:** Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Goal Processing Scale (GPS) Overall Performance Score
**Unit of Measure:** score on a scale
### Measure 7
**Description:** Overall psychological distress will be assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure).

(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Profile of Mood States (POMS)-Total Mood Disturbance Score
**Unit of Measure:** z score
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** One important limitation of this study is a relatively small sample size, which may have also resulted in our interaction analyses being under powered, possibly leading to failure to detect true effects of group on outcomes
### Point of Contact
**Email:** tatjana.novakovic-agopian@va.gov
**Organization:** San Francisco VA HCS
**Phone:** 415-753-3888
**Title:** Dr Tatjana Novakovic-Agopian
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### 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:** 
**Non-Inferiority Comment:** A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on neurocognitive performance Attention and Executive Function Overall Domain Z Score
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** <0.01
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### 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:** 
**Non-Inferiority Comment:** A repeated measure multivariate analysis of variance (MANOVA) was used to compare neurocognitive performance on Overall Attention /Executive Function overall score at baseline and at 6+ month post-GOALS training follow-up
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Repeated measure MANOVA was used to compare performance on neurocognitive domain scores at baseline and at 6+ month follow-up post-GOALS training
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### 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:** 
**Non-Inferiority Comment:** A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** >0.05
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### 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:** 
**Non-Inferiority Comment:** A repeated measure multivariate analysis of variance (MANOVA) was used to compare performance on Goal Processing Scale Overall domain scores at baseline and 6+ month post-GOALS training follow-up
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** <0.001
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### 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:** 
**Non-Inferiority Comment:** A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on emotional regulation measures - POMS Total score
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** <0.05
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** A repeated measures MANOVA was used to compare the impact of GOALS versus the BHE training on emotional regulation measures - POMS Total score
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### 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:** 
**Non-Inferiority Comment:** A repeated measure multivariate analysis of variance (MANOVA) was used to compare participants' self-report on POMS Total Mood Disturbance overall score at baseline and 6+ month post-GOALS training follow-up
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** <0.01
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.68
- **Upper Limit:** 
- **Value:** -0.03
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.72
- **Upper Limit:** 
- **Value:** -0.39
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.78
- **Upper Limit:** 
- **Value:** -0.2
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.10
- **Upper Limit:** 
- **Value:** 8.10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.04
- **Upper Limit:** 
- **Value:** 7.60
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.20
- **Upper Limit:** 
- **Value:** 8.23
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.82
- **Upper Limit:** 
- **Value:** -1.37
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.94
- **Upper Limit:** 
- **Value:** -2.09
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.40
- **Upper Limit:** 
- **Value:** -1.01
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching.

(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Out of 21 participants who completed GOALS, 3 participants did not complete one or more neuropsychological tests
**Reporting Status:** POSTED
**Time Frame:** baseline, 5 weeks
**Title:** Change in Performance on Neurocognitive Measure of Attention and Executive Function Post GOALS Intervention vs EDU Control Training
**Type:** PRIMARY
**Unit of Measure:** z score
##### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training, 3 hours of individual training, and approximately 20 hours of home practice. GOALS is therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and problem solving applied to participant-defined real-life goals.

Participants randomized to the GOALS intervention, did no receive EDU training after completion of GOALS.
**ID:** OG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
##### Group
**Description:** Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training), 3 hours of individual training, and approximately 20 hours of homework). The EDU intervention is therapist administered, and involves education on brain health and functioning in a classroom format, with study materials for homework.

Participants randomized to EDU intervention were offered to participate in GOALS training after completion of EDU training.
**ID:** OG001
**Title:** EDU (Brain Health Education)
#### Outcome Measure 2
**Description:** Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching.

(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** baseline, 6+ months after GOALS training
**Title:** Long Term Follow-up After GOALS Training - Change in Performance on Neurocognitive Measures of Attention and Executive Function 6+ Months Post GOALS Intervention Relative to Baseline
**Type:** PRIMARY
**Unit of Measure:** z score
##### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.
**ID:** OG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
#### Outcome Measure 3
**Description:** Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Out of 21 participants who completed GOALS training 3 participants did not complete one or more sub-tests of GPS.

Out of 19 participants who completed EDU training 2 participants did not complete one or more sub-tests of GPS
**Reporting Status:** POSTED
**Time Frame:** baseline; 5 weeks
**Title:** Change in Performance on Complex Functional Task -Goal Processing Scale Post GOALS Intervention vs EDU Control Training
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training, 3 hours of individual training, and approximately 20 hours of home practice. GOALS is therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and problem solving applied to participant-defined real-life goals.

Participants randomized to the GOALS intervention, did no receive EDU training after completion of GOALS.
**ID:** OG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
##### Group
**Description:** Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training), 3 hours of individual training, and approximately 20 hours of homework). The EDU intervention is therapist administered, and involves education on brain health and functioning in a classroom format, with study materials for homework.

Participants randomized to EDU intervention were offered to participate in GOALS training after completion of EDU training.
**ID:** OG001
**Title:** EDU (Brain Health Education)
#### Outcome Measure 4
**Description:** Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** baseline, 6 months post GOALS training
**Title:** Long Term Follow-up After GOALS Training - Change in Performance on Complex Functional Task -Goal Processing Scale 6+ Months Post GOALS Intervention Relative to Baseline
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.
**ID:** OG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
#### Outcome Measure 5
**Description:** Overall psychological distress will be assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure).

(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Out of 21 participants who completed GOALS training 3 participants did not complete one or more questions on POMS Out of 19 participants who completed EDU training 2 participants did not complete one or more questions on POMS
**Reporting Status:** POSTED
**Time Frame:** baseline, 5 weeks
**Title:** Change on Self Report Measures of Emotional Regulation GOALS Post Intervention vs EDU Control Training
**Type:** SECONDARY
**Unit of Measure:** z score
##### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training, 3 hours of individual training, and approximately 20 hours of home practice. GOALS is therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and problem solving applied to participant-defined real-life goals.

Participants randomized to the GOALS intervention, did no receive EDU training after completion of GOALS.
**ID:** OG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
##### Group
**Description:** Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training), 3 hours of individual training, and approximately 20 hours of homework). The EDU intervention is therapist administered, and involves education on brain health and functioning in a classroom format, with study materials for homework.

Participants randomized to EDU intervention were offered to participate in GOALS training after completion of EDU training.
**ID:** OG001
**Title:** EDU (Brain Health Education)
#### Outcome Measure 6
**Description:** Overall psychological distress is assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure)

(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** baseline, 6 months
**Title:** Long Term Follow-up Change on Self Report Measures of Emotional Regulation 6+ Months Post GOALS Intervention
**Type:** SECONDARY
**Unit of Measure:** z score
##### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.
**ID:** OG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
### Participant Flow Module
#### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.
**ID:** FG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
#### Group
**Description:** Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.
**ID:** FG001
**Title:** EDU (Brain Health Education)
#### Period
**Title:** 5 Week Randomized GOALS vs EDU Training
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 24
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 22
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 19
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
#### Period
**Title:** Long Term Follow-up After GOALS Training
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 32
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Pre-Assignment Details:** Out of 76 enrolled participants: 12 were excluded after in person screening for not meeting inclusion criteria CAPS diagnosis of PTSD (n=11), or substance abuse (n=1); 8 participants left study after consent for scheduling, medical/family issues; and 10 left study during baseline assessment (were not randomized)

46 participants were randomized
**Has Results:** True