Comparing TBT to Disorder-Specific Psychotherapy in Veterans With Social Anxiety Disorder
Part of paid clinical trials in Charleston, South Carolina.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT05858346
- Status
- Recruiting
Conditions
- Social Anxiety 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 Behavioral Therapy for Social Anxiety Disorder — BEHAVIORALTo provide an evidence-based comparison for the TBT condition, the research-supported psychological treatment of CBT for SAD will be used. CBT for SAD demonstrates efficacy in improving SAD symptoms and quality of life for patients with SAD, with durable improvements evidenced at follow-up assessments. CBT for SAD was used as a comparison to TBT in previous preliminary research. CBT for SAD involves several primary components, including: 1) psychoeducation, 2) training in cognitive restructuring, 3) exposures, 4) advanced cognitive restructuring, and 5) termination.
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. The proposed research seeks to evaluate the efficacy of TBT by assessing psychiatric symptomatology and related impairment outcomes in Veterans with social anxiety disorder and comorbid posttraumatic stress via a randomized controlled trial of TBT and an existing DST. 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
- Apr 1, 2024
- Status verified
- Feb 2026
- Primary completion
- Apr 1, 2027
- Completion
- Oct 31, 2027
Study Design
- Enrollment
- 264 participants (estimated)
- 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: Cognitive Behavioral Therapy for Social Anxiety DisorderTo provide an evidence-based comparison for the TBT condition, the research-supported psychological treatment of CBT for SAD will be used. CBT for SAD demonstrates efficacy in improving SAD symptoms and quality of life for patients with SAD, with durable improvements evidenced at follow-up assessments. CBT for SAD was used as a comparison to TBT in previous preliminary research. CBT for SAD involves several primary components, including: 1) psychoeducation, 2) training in cognitive restructuring, 3) exposures, 4) advanced cognitive restructuring, and 5) termination.
Primary Outcome Measure
MASA functional impairment [ Time Frame: change from baseline to week 6 to week 12 to 6-month followup ]
Central Contacts
- Daniel F Gros, PhD MA BS(843) 789-6225
- Lacey Bonner, MA(843) 577-5011
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5703 | Daniel F Gros, PhD MA BS (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Charleston, SC
Related Studies
- Computer - Based Treatment for Social Anxiety DisorderRecruiting · New York State Psychiatric Institute · New York, New York
- Validating an Autonomous Interactive Internet-Based Delivery of an Empirically Supported Cognitive Behavioral Therapy for ComorbidityRecruiting · University of Minnesota · Minneapolis, Minnesota
- Respiratory Training in the Treatment of Transdiagnostic Pathological AnxietyRecruiting · University of Texas at Austin · Austin, Texas
- CO2 Reactivity as a Biomarker of Non-Response to Exposure-Based TherapyRecruiting · Jasper A. Smits · Boston, Massachusetts