Comparing TBT to Disorder-Specific Psychotherapy in Veterans With Social Anxiety Disorder

NCT05858346 | Recruiting DMC

• 1 other identifier: D4516-R
• Study Type: interventional
• Target: 264
• 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. 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

Outcome Measures

Primary Outcomes (3)

• MASA functional impairment

  The MASA is a 38-item self-report measure that was designed to assess trait symptom dimensions consistent with the hybrid model of social anxiety. The MASA contains six subscales that assess behavioral avoidance, physiological arousal and avoidance, thought avoidance, anhedonia, functional impairment, and coping with substances. The six subscales have shown to differentiate symptoms across anxiety disorders and depression and their comorbidities and to be sensitive to improvements evidenced in therapy.

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

• 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

• Illness Intrusiveness Rating Scale (IIRS)

  The IIRS is a 13-item questionnaire that assesses the extent to which a disease interferes with important domains of life, including health, diet, work, and several others. The IIRS has been shown to have strong psychometric properties in the previous literature in participants with physical and emotional health concerns, and has been used in previous TBT studies.

  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

Cognitive Behavioral Therapy for Social Anxiety Disorder

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Behavioral Therapy for Social Anxiety 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 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.

Cognitive Behavioral Therapy for Social Anxiety Disorder

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 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

You may not qualify if:

• 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.

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

RECRUITING

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Daniel F Gros, PhD MA BS

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel F Gros, PhD MA BS

CONTACT

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

Lacey Bonner, MA

CONTACT

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

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: April 25, 2023
• First Posted: May 15, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

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)