NCT05858346 Comparing TBT to Disorder-Specific Psychotherapy in Veterans With Social Anxiety Disorder
| NCT ID | NCT05858346 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Social Anxiety Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 264 participants in total. It began in 2024-04-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Daniel F Gros, PhD MA BS
PRINCIPAL INVESTIGATOR
Ralph H. Johnson VA Medical Center, Charleston, SC
Frequently Asked Questions
Who can join the NCT05858346 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Social Anxiety Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05858346 currently recruiting?
Yes, NCT05858346 is actively recruiting participants. Contact the research team at daniel.gros@va.gov for enrollment information.
Where is the NCT05858346 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05858346 clinical trial?
NCT05858346 is sponsored by VA Office of Research and Development. The principal investigator is Daniel F Gros, PhD MA BS at Ralph H. Johnson VA Medical Center, Charleston, SC. The trial plans to enroll 264 participants.
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