Recruiting

TBT vs. Disorder-Specific Psychotherapy

Sponsor:

VA Office of Research and Development

Code:

NCT05858346

Conditions

Social Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transdiagnostic Behavior Therapy

Cognitive Behavioral Therapy for Social Anxiety Disorder

Study Details

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. 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.

Conditions

Social Anxiety Disorder

Study ID

NCT05858346

Start date

Apr 1, 2024

Status verified date

Feb, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must be Veterans and registered at Ralph H. Johnson Veterans Affairs Health Care System
  • Participants must be clearly competent to provide informed consent for research participation
  • Participants must meet DSM-5 criteria for social anxiety disorder
  • Participants must have clinically significant symptoms of comorbid posttraumatic stress

Exclusion Criteria:

  • recent history (< 2 months) of psychiatric hospitalization or a suicide attempt as documented in their medical record,
  • acute, severe illness or medical condition that likely will interfere with study procedures as documented in their medical record
  • recent start of new psychiatric medication(s) (< 4 weeks),
  • primary diagnosis of a condition associated with psychotic symptoms, personality disorder, substance use disorder, or bipolar disorder.

Study Design

Enrollment

264 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 ]
  • PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: change from baseline to week 6 to week 12 to 6-month followup ]
  • Illness Intrusiveness Rating Scale (IIRS) [ Time Frame: change from baseline to week 6 to week 12 to 6-month followup ]

Central Contacts and Locations

Central contacts

Daniel F Gros, PhD MA BS

(843) 789-6225daniel.gros@va.gov

Lacey Bonner, MA

(843) 577-5011lacey.bonner@va.gov

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Recruiting

Charleston, South Carolina, United States, 29401-5703

Contacts

Daniel F Gros, PhD MA BS

843-789-6225daniel.gros@va.gov

Lacey Bonner, MA

(843) 577-5011lacey.bonner@va.gov

Principal Investigator:

Daniel F Gros, PhD MA BS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-02-10.