## Protocol Section
### Identification Module
**NCT ID:** NCT06433271

**Brief Title:** Transdiagnostic Behavior Therapy vs TAU for Adjustment Disorder Following Traumatic Event Exposure

**Official Title:** Comparative Effectiveness of Transdiagnostic Behavior Therapy vs TAU for Adjustment Disorder Following Traumatic Event Exposure

#### Organization Study ID Info
**ID:** Pro00134707
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center, Houston
#### Secondary ID Infos
**Domain:** United States Army Medical Research and Development Command
**ID:** PR230007
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2029-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2028-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** FED

**Name:** Ralph H. Johnson VA Medical Center

**Class:** FED

**Name:** U.S. Army Medical Research and Development Command

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Texas Health Science Center, Houston

#### Responsible Party

**Investigator Affiliation:** The University of Texas Health Science Center, Houston

**Investigator Full Name:** Ronald E. Acierno

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Adjustment Disorder (AjD) is the most common mental health condition diagnosed in Active Duty personnel, and is diagnosed following an extreme stress event such as traumatic loss of a comrade, serious accident or injury, or other intense stress event. Despite its high prevalence, no evidence based treatment for AjD has been subjected to randomized controlled trials. This study seeks to build on the research team's pilot work across several disorders study to benefit service members and Veterans with AjD, a highly prevalent but frequently inadequately treated condition.

We will compare the effects of Transdiagnostic Behavior Therapy (TBT) vs treatment as usual which is Moving Forward Problem Solving Therapy (TAU-PST) on AjD symptom outcomes. We hypothesize that TBT will result in greater overall symptom reduction compared to TAU-PST.

**Detailed Description:** Adjustment Disorder (AjD) is the most common mental health condition diagnosed in Active Duty personnel, and is diagnosed following an extreme stress event such as traumatic loss of a comrade, serious accident or injury, or other intense stress event. Despite its high prevalence, no evidence based treatment for AjD has been subjected to randomized controlled trials.

Currently, the VA suggests a problem solving cognitive behavioral therapy, but this recommendation is not based on replicated, randomized controlled trials. Transdiagnostic Behavior Therapy (TBT), is based on key 'active components' of existing evidence based treatments such as Prolonged Exposure and Behavioral Activation, has been designed by this research team to be easily trained and inexpensively disseminated, and has been evaluated in a series of pilots with anxiety and depression disorders that, importantly, represent the key symptom classes of adjustment disorder.

Thus, the rationale for the proposed trial is that the research team has done preliminary efficacy testing of an easily exportable intervention that has impact on the key symptoms of adjustment disorder, and the standard of evidence demands replicated, randomized controlled trials to determine if initial signals of positive effect are sustained.

The study will use a 2 group repeated measures randomized controlled design to evaluate effectiveness of TBT for AjD compared to treatment as usual (TAU-PST). Participants will be randomly assigned in equal numbers (n = 75; N = 150) to one of two treatment arms: (1) TBT or (2) TAU-PST. Participants assigned to TBT will receive 10-14, 45-60-minute, manualized, individual therapy sessions. Participants assigned to TAU-PST will receive 10-14, 45-60-minute sessions of Problem-Solving Therapy. Dependent measures will include Department of Defense (DoD) specified common data elements and specific measures of AjD, PTSD, anxiety, depression, and functioning collected by blinded assessors at baseline, post-treatment, 3-month, and 6-month follow-up.

### Conditions Module

**Conditions:**

- Adjustment Disorders

- Mental Disorder

**Keywords:**

- Veterans

- Military Personnel

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive 10-14, 45-60-minute, manualized, individual therapy sessions.

**Intervention Names:**

- Behavioral: Transdiagnostic Behavior Therapy (TBT)

**Label:** Transdiagnostic Behavior Therapy (TBT)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive 10-14, 45-60-minute individual therapy sessions.

**Intervention Names:**

- Behavioral: Treatment as Usual-Problem Solving Therapy (TAU-PST)

**Label:** Active Comparator: Treatment as Usual-Problem Solving Therapy (TAU-PST)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Transdiagnostic Behavior Therapy (TBT)

**Description:** TBT manualized treatment incorporates daily exposure exercises from up to four categories of avoidance that are most characteristic of the emotional disorders (i.e., situational, interoceptive, imaginal, and positive emotional).

**Name:** Transdiagnostic Behavior Therapy (TBT)

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Active Comparator: Treatment as Usual-Problem Solving Therapy (TAU-PST)

**Description:** PST is an evidence- based psychotherapy implemented in VA Primary Care - Mental Health Integration (PC-MHI), with hundreds of VA providers trained in the intervention nationally. The primary aim of PST is to improve a patient's ability to cope with stressful events by adopting an adaptive perspective to stressors and using goal-focused, problem-solving behaviors to manage the problems associated with the stressors.

**Name:** Treatment as Usual-Problem Solving Therapy (TAU-PST)

**Other Names:**

- Moving Forward Problem Solving Therapy

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The Adjustment Disorder New Module (ADNM) is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with International Classification of Diseases 11th Revision (ICD-11) criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder.

**Measure:** Adjustment Disorder New Module Self Report

**Time Frame:** Baseline

**Description:** The ADNM is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with ICD-11 criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder.

**Measure:** Adjustment Disorder New Module Self Report

**Time Frame:** 1 week post treatment

**Description:** The ADNM is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with ICD-11 criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder.

**Measure:** Adjustment Disorder New Module Self Report

**Time Frame:** 3 months post treatment

**Description:** The ADNM is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with ICD-11 criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder.

**Measure:** Adjustment Disorder New Module Self Report

**Time Frame:** 6 months post treatment

**Description:** The Post-traumatic stress disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (PCL-5) (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity.

**Measure:** PTSD Checklist-5

**Time Frame:** Baseline

**Description:** The PCL-5 (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity.

**Measure:** PTSD Checklist-5

**Time Frame:** 1 week post treatment

**Description:** The PCL-5 (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity.

**Measure:** PTSD Checklist-5

**Time Frame:** 3 months post treatment

**Description:** The PCL-5 (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity.

**Measure:** PTSD Checklist-5

**Time Frame:** 6 months post treatment

**Description:** The Patient Health Questionnaire-9 (PHQ-9) (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for major depressive disorder (MDD). This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).

**Measure:** Patient Health Questionnaire-9

**Time Frame:** Baseline

**Description:** The PHQ-9 (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).

**Measure:** Patient Health Questionnaire-9

**Time Frame:** 1 week post treatment

**Description:** The PHQ-9 (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).

**Measure:** Patient Health Questionnaire-9

**Time Frame:** 3 months post treatment

**Description:** The PHQ-9 (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).

**Measure:** Patient Health Questionnaire-9

**Time Frame:** 6 months post treatment

#### Secondary Outcomes

**Description:** The Insomnia Severity Index (ISI) self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.

**Measure:** Insomnia Severity Index

**Time Frame:** Baseline

**Description:** The ISI self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.

**Measure:** Insomnia Severity Index

**Time Frame:** 1 week post treatment

**Description:** The ISI self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.

**Measure:** Insomnia Severity Index

**Time Frame:** 3 months post treatment

**Description:** The ISI self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.

**Measure:** Insomnia Severity Index

**Time Frame:** 6 months post treatment

**Description:** The Short Form-36 (SF-36) (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status.

**Measure:** Medical Outcome Study Short Form-36 Health Survey

**Time Frame:** Baseline

**Description:** The SF-36 (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status.

**Measure:** Medical Outcome Study Short Form-36 Health Survey

**Time Frame:** 1 week post treatment

**Description:** The SF-36 (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status.

**Measure:** Medical Outcome Study Short Form-36 Health Survey

**Time Frame:** 3 months post treatment

**Description:** The SF-36 (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status.

**Measure:** Medical Outcome Study Short Form-36 Health Survey

**Time Frame:** 6 months post treatment

**Description:** Number of treatment sessions completed.

**Measure:** Dose Received

**Time Frame:** 14 weeks after treatment starts

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult male or female over the age of 18 that has served, or is currently serving, in the military.
* Stable psychotropic medication for at least 4 weeks if applicable
* Current DSM-5 diagnosis of Adjustment Disorder

Exclusion Criteria:

* Active psychosis
* Suicidal ideation with clear intent
* Severe substance use

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** stephanie.hart4@va.gov

**Name:** Stephanie M Hart, MPH

**Phone:** 8435775011

**Phone Ext:** 205103

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Charleston

**Contacts:**

***Contact 1:***

- **Email:** stephanie.hart4@va.gov

- **Name:** Stephanie M Hart, MPH

- **Phone:** 843-577-5011

- **Phone Ext:** 205103

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ron Acierno, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Daniel Gros, PhD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Ralph H. Johnson VA Health Care System

**State:** South Carolina

**Zip:** 29401

#### Overall Officials

**Official 1:**

**Affiliation:** McGovern Medical School at UTHealth Houston

**Name:** Ron Acierno, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Gros DF. Development and initial evaluation of Transdiagnostic Behavior Therapy (TBT) for veterans with affective disorders. Psychiatry Res. 2014 Dec 15;220(1-2):275-82. doi: 10.1016/j.psychres.2014.08.018. Epub 2014 Aug 15.

**PMID:** 25193379

**Citation:** Gros DF, Allan NP. A randomized controlled trial comparing Transdiagnostic Behavior Therapy (TBT) and behavioral activation in veterans with affective disorders. Psychiatry Res. 2019 Nov;281:112541. doi: 10.1016/j.psychres.2019.112541. Epub 2019 Aug 29.

**PMID:** 31514043

**Citation:** Gros DF, Merrifield C, Rowa K, Szafranski DD, Young L, McCabe RE. A Naturalistic Comparison of Group Transdiagnostic Behaviour Therapy (TBT) and Disorder-Specific Cognitive Behavioural Therapy Groups for the Affective Disorders. Behav Cogn Psychother. 2019 Jan;47(1):39-51. doi: 10.1017/S1352465818000309. Epub 2018 May 29.

**PMID:** 29807553

**Citation:** Gros DF, Szafranski DD, Shead SD. A real world dissemination and implementation of Transdiagnostic Behavior Therapy (TBT) for veterans with affective disorders. J Anxiety Disord. 2017 Mar;46:72-77. doi: 10.1016/j.janxdis.2016.04.010. Epub 2016 Apr 27.

**PMID:** 27158076

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M4815

- Name: Mental Disorders

- Relevance: HIGH

- As Found: Mental Disorders

- ID: M3627

- Name: Adjustment Disorders

- Relevance: HIGH

- As Found: Adjustment Disorders

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001523

- Term: Mental Disorders

- ID: D000000275

- Term: Adjustment Disorders

### Misc Info Module

- Version Holder: 2024-05-31
