Comparing Individual Therapies for Veterans With Depression, PTSD, and Panic Disorder

NCT04293341 | Completed Results DMC

• 1 other identifier: MHBB-005-19S
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive behavioral therapy (CBT) is a brief, efficient, and effective treatment for individuals with depressive/anxiety disorders. However, CBT is largely underutilized within the Department of Veterans Affairs due to the cost and burden of trainings necessary to deliver all of the related disorder-specific treatments (DSTs). Transdiagnostic Behavior Therapy (TBT), in contrast, is specifically designed to address numerous distinct disorders within a single protocol in Veterans with depressive/anxiety disorders, including posttraumatic stress disorder. The proposed research seeks to evaluate the efficacy of TBT by assessing psychiatric symptomatology and related impairment outcomes in Veterans with depressive/anxiety disorders via a randomized controlled trial of TBT and existing DSTs in Veterans with major depressive disorder, posttraumatic stress disorder, and panic disorder. Assessments will be completed at pre-, mid-, and post-treatment, and at 6-month follow-up. Process variables also will be investigated.

Conditions

Major Depressive Disorder; Posttraumatic Stress Disorder; Panic Disorder and Agoraphobia

Outcome Measures

Primary Outcomes (3)

• PTSD Checklist for DSM-5 (PCL-5)

  The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses DSM-5 criteria PTSD symptoms. Items are scored on a 5-point scale, range from 0 (not at all) to 4 (extremely). The total scale score ranges from 0 to 80 with higher scores associated with more severe symptomatology. Previous versions of the PCL have been shown to have excellent internal consistency and excellent test-retest reliability in Veterans. In addition, the PCL-5 has been incorporated into standard assessment for PTSD at the VA. The PCL5 will be used to assess symptoms of PTSD.

  change from baseline to week 6 to week 12 to 6-month followup

• Patient Health Questionnaire - 9 (PHQ-9)

  The Patient Health Questionnaire - 9 (PHQ-9) is a 9-item depression scale derived from the Patient Health Questionnaire to assess the symptoms and diagnosis of depression. Items are scored on a 4-point scale, range from 0 (not at all) to 3 (nearly every day). The total scale score ranges from 0 to 27 with higher scores associated with more severe symptomatology. The PHQ-9 has been shown to have good reliability as well as validity in clinical samples. In addition, the PHQ-9 has been incorporated into standard screenings at the VA. The PHQ-9 will be used to assess symptoms of MDD.

  change from baseline to week 6 to week 12 to 6-month followup

• Panic Disorder Severity Scale (PDSS)

  The Panic Disorder Severity Scale (PDSS) is a 7-item scale for the frequency and distress of panic attacks and related symptoms. Items are scored on a 5-point scale, range from 0 (no symptoms) to 4 (extreme symptoms). The total scale score ranges from 0 to 28 with higher scores associated with more severe symptomatology. The scale has demonstrated good internal consistency, test-retest reliability, and sensitivity to change during the course of treatment . The PDSS will be used to assess symptoms of PD/AG.

  change from baseline to week 6 to week 12 to 6-month followup

Study Arms (2)

Transdiagnostic Behavior Therapy

EXPERIMENTAL

TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.

Behavioral: Transdiagnostic Behavior Therapy

Disorder Specific Therapies

ACTIVE COMPARATOR

To provide an evidence-based comparison for the TBT condition, DSTs will be used that are matched to the participant's most severe diagnosis, based upon the average of the ADIS interference and distress scores. If the scores are equivalent for two or more diagnoses, participants will be asked to list which diagnosis/symptoms that they find most impairing. DSTs will be included for each of the three targeted diagnoses, including PTSD (CPT for PTSD), PD/AG (CBT for PD/AG), and MDD (CBT for MDD). Each of these DSTs have published manuals for administration and have received extensive support in the literature (Barlow, 2014).

Behavioral: Cognitive Processing Therapy for PTSD; Behavioral: Cognitive Behavioral Therapy for MDD; Behavioral: Cognitive Behavioral Therapy for Panic Disorder

Interventions

Transdiagnostic Behavior Therapy BEHAVIORAL

TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.

Transdiagnostic Behavior Therapy

Cognitive Processing Therapy for PTSD BEHAVIORAL

CPT is a well established evidence-based psychotherapy for PTSD. CPT focuses on teaching patients to evaluate and change the upsetting thoughts that they have had since their trauma.

Disorder Specific Therapies

Cognitive Behavioral Therapy for MDD BEHAVIORAL

CBT for MDD is a well established evidence-based psychotherapy for depression. CBT for MDD focuses teaching patients how to change their behaviors and challenge their negative thoughts to improve their mood.

Disorder Specific Therapies

Cognitive Behavioral Therapy for Panic Disorder BEHAVIORAL

CBT for Panic Disorder is a well established evidence-based psychotherapy. CBT for Panic Disorder focuses teaching patients how to change their behaviors through exposure practices and challenge their anxious thoughts to reduce their experience of panic attacks and avoidance.

Disorder Specific Therapies

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be Veterans
• Participants must be clearly competent to provide informed consent for research participation
• Participants must meet DSM-5 criteria for panic disorder, major depressive disorder, or posttraumatic stress disorder
• Participants must be 18-80 years old

You may not qualify if:

• recent history (\< 2 months) of psychiatric hospitalization or a suicide attempt as documented in their medical record or reported during clinical interview
• acute, severe illness or medical condition that likely will require hospitalization and/or otherwise interfere with study procedures as documented in their medical record (e.g., active chemotherapy/radiation treatment for cancer),
• recent start of new psychiatric medication (\< 4 weeks)
• diagnosis of moderate-to-severe traumatic brain injury in their medical record and/or endorsement of screener questionnaire
• ineligible Veterans will be referred for non-study-related treatments within mental health at the RHJ VAMC

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Stress Disorders, Post-Traumatic; Panic Disorder; Agoraphobia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Anxiety Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Due to COVID-19 pandemic safety protocols, all procedures were completed via telehealth technologies with paper documentation exchanged via the United States Postal Service in accordance with VA pandemic-related research policies from November 2020 to September 2023, at which point procedures were transitioned to electronic delivery (e.g., REDCap) and in-person appointments (when requested) for the remainder of the study. These procedures resulted in higher than expected rates of missing data.

Results Point of Contact

• Title: Daniel Gros, PhD
• Organization: Department of Veterans Affairs

daniel.gros@va.gov

843-789-7311

Study Officials

• Daniel F Gros, PhD MA BS

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: October 1, 2020
• Primary Completion: January 1, 2025
• Study Completion: March 31, 2025
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after publication of the primary outcome papers

Locations

US (1)