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 — 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.
  • Cognitive Behavioral Therapy for Social Anxiety Disorder — BEHAVIORAL
    To 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 Therapy
    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.
  • Active Comparator: Cognitive Behavioral Therapy for Social Anxiety Disorder
    To 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

Locations (1)

FacilityCityStateZIPSite coordinators
Ralph H. Johnson VA Medical Center, Charleston, SCCharlestonSouth Carolina29401-5703
Daniel F Gros, PhD MA BS
843-789-6225
Lacey Bonner, MA
(843) 577-5011
Daniel F Gros, PhD MA BS (PRINCIPAL_INVESTIGATOR)

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