Recruiting

CBT Factors

Sponsor:

University of Washington

Code:

NCT06678295

Conditions

Social Anxiety Disorder

Body Dysmorphic Disorder

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Cognitive Behavioral Therapy

Study Details

Brief summary:

The purpose of this study is to understand why some individuals respond fully to cognitive behavioral therapy and others do not, based on multiple sources of data such as neural, neurocognitive, clinical, and self-report data.

Conditions

Social Anxiety Disorder

Body Dysmorphic Disorder

Study ID

NCT06678295

Start date

Oct 15, 2024

Status verified date

Feb, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

Clinical sample (N=110):

1. Men and women, age 18-45
2. Treatment-seeking individuals who meet criteria for a primary DSM-5 diagnosis of primary social anxiety disorder (SAD) or body dysmorphic disorder (BDD) based on the SCID-5-RV
3. Fluent in English and willing to provide informed consent.

Control sample (N=50):

1. Men and women, age 18-45
2. No current or lifetime history of psychiatric disorders, as assessed using the SCID-5-RV
3. Meet criteria for low levels of anxiety (GAD-7 score of <8) and depression (PHQ-9 score <10)
4. Fluent in English and willing to provide informed consent

Exclusion Criteria:

All groups:

1. Score < 80 based on WRAT5 Word Reading Subtest
2. fMRI contraindications (e.g., electronic medical devices such as pacemakers, implanted defibrillators, etc.; metal implants not approved for MRI; pregnancy; claustrophobia)

2\. Active suicidal or homicidal ideation, or any features requiring a higher level of care 3. Lifetime history of manic or hypomanic episode, psychotic symptoms, traumatic brain injury, neurological disorder, pervasive developmental disorder, or attention deficit-hyperactivity disorder; active alcohol or substance use disorder in the past 6 months 4. Current use of psychotropic medications, except antidepressants taken at a stable dose for 3 months prior to study baseline 5. Previous CBT non-responder or current CBT

Study Design

Enrollment

160 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive behavioral therapy

Twelve weekly sessions of individual cognitive behavioral therapy

Interventions

Cognitive Behavioral Therapy

Twelve weekly sessions of individual cognitive behavioral therapy

Primary outcome measure

  • Trait SFA assessed by the Public Self-Consciousness Scale- Revised (SCS-R) [ Time Frame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment ]
  • Functional connectivity between the Default Mode and Dorsal Attention Networks (DMN-DAN) [ Time Frame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment ]
  • Anxiety symptom severity, assessed by the Structured Interview Guide for Hamilton Anxiety Scale (SIGH-A) and the Generalized Anxiety Disorder (GAD-7) [ Time Frame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment ]
  • Anxiety symptom severity, assessed by the Generalized Anxiety Disorder (GAD-7) [ Time Frame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment ]
  • Symptom severity associated with primary disorder, assessed by self-report versions of the Liebowitz Social Anxiety Scale (LSAS SR). [ Time Frame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment. DSM5 Cross Cutting: Baseline (T-2weeks), Repeat Baseline (T0), Post-treatment ]
  • Symptom severity associated with primary disorder, assessed by self-report version of the Yale-Brown Obsessive-Compulsive Scale Modified for BDD (BDD-YBOCS SR). [ Time Frame: Across the span of 3 1/2 months: BDD-YBOCS: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment. DSM5 Cross Cutting: Baseline (T-2weeks), Repeat Baseline (T0), Post-treatment ]
  • DSM5 Cross Cutting Form [ Time Frame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment. DSM5 Cross Cutting: Baseline (T-2weeks), Repeat Baseline (T0), Post-treatment ]

Central Contacts and Locations

Central contacts

Angela Fang, PhD

(206) 616-5783angfang@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98105

Contacts

Randhara Kotuwelle, B.A.

206-221-1278ifocuscbt@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Body Dysmorphic Disorder
  • Social Anxiety Disorder
  • Social Phobia
  • Self focused attention
  • fMRI
  • CBT
  • Cognitive Behavior Therapy
  • BDD
  • SAD
  • Neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by University of Washington on 2026-02-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.