Comparing Individual Therapies for Veterans With Depression, PTSD, and Panic Disorder
Part of paid clinical trials in Charleston, South Carolina.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT04293341
- Status
- Completed
Conditions
- Major Depressive Disorder
- Panic Disorder and Agoraphobia
- Posttraumatic Stress Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Transdiagnostic Behavior Therapy — BEHAVIORALTBT 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.
- Cognitive Processing Therapy for PTSD — BEHAVIORALCPT 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.
- Cognitive Behavioral Therapy for MDD — BEHAVIORALCBT 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.
- Cognitive Behavioral Therapy for Panic Disorder — BEHAVIORALCBT 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.
Study Details
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.
Key Dates
- Start date
- Oct 1, 2020
- Status verified
- Oct 2025
- Primary completion
- Jan 1, 2025
- Completion
- Mar 31, 2025
Study Design
- Enrollment
- 304 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Transdiagnostic Behavior TherapyTBT 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.
- Active Comparator: Disorder Specific TherapiesTo 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).
Primary Outcome Measure
PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: change from baseline to week 6 to week 12 to 6-month followup ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5703 | - |
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