Individual Factors of CBT Underlying Success

NCT06678295 | Recruiting DMC

• 2 other identifiers: STUDY00019785R01MH133581
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Trait SFA assessed by the Public Self-Consciousness Scale- Revised (SCS-R)

  Participants will complete the 7-item self-report Public SCS-R measure to assess trait self-focused attention.

  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)

  Participants will complete an MRI scan comprising both task and resting state fMRI to derive a measure of intrinsic functional connectivity between DMN and DAN using general functional connectivity.

  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)

  The SIGH-A is a 14-item clinician-rated assessment of past-week anxiety symptom severity. Scores on the SIGH-A (together with scores on the CGI-I) will be used to calculate a categorical measure of treatment response (e.g., Remitters, Partial Responders, or NonResponders). SIGH-A items will be adapted to accommodate anxiety symptoms in a transdiagnostic sample (e.g., accounting for specific disorder-relevant fears in item 3, such as fear of negative appearance evaluation in BDD). Generalized Anxiety Disorder (GAD-7) is a 7-item self-report measure of severe anxiety

  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)

  Generalized Anxiety Disorder (GAD-7) is a 7-item self-report measure of severe anxiety

  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).

  Total scores from the LSAS-SR will be used toward calculating a categorical measure of treatment response (e.g., Remitters, Partial Responders, or NonResponders). Scores will also be examined as a dimensional measure of symptom severity change during treatment based on the participant's primary disorder. Standardized change scores will be calculated based on the pretreatment score on the selected measure.

  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).

  Total scores from the BDD-YBOCS-SR will be used toward calculating a categorical measure of treatment response (e.g., Remitters, Partial Responders, or NonResponders). Scores will also be examined as a dimensional measure of symptom severity change during treatment based on the participant's primary disorder. Standardized change scores will be calculated based on the pretreatment score on the selected measure.

  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

  The DSM-5 Cross Cutting Measure is a 24-item self-report measure that assesses symptom related problems over the past 2 weeks.

  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

Secondary Outcomes (11)

• Trait rumination assessed by the Ruminative Responses Scale (RRS)

  Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment

• Trait worry assessed by the Penn State Worry Questionnaire (PSWQ)

  Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment

• Reaction times during Self trials in Self-Other Task

  Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment

• Alerting, orienting, and attentional control reaction time scores on the Attention Network Test (ANT)

  Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment

• Depression severity, as assessed by the Quick Inventory of Depressive Symptomatology (QIDS-SR)

  Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment

Study Arms (1)

Cognitive behavioral therapy

EXPERIMENTAL

Twelve weekly sessions of individual cognitive behavioral therapy

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Twelve weekly sessions of individual cognitive behavioral therapy

Cognitive behavioral therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical sample (N=110):
• Men and women, age 18-45
• 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
• Fluent in English and willing to provide informed consent.
• Control sample (N=50):
• Men and women, age 18-45
• No current or lifetime history of psychiatric disorders, as assessed using the SCID-5-RV
• Meet criteria for low levels of anxiety (GAD-7 score of \<8) and depression (PHQ-9 score \<10)
• Fluent in English and willing to provide informed consent

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Phobia, Social; Body Dysmorphic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Somatoform Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Angela Fang, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Fang, PhD

CONTACT

(206) 616-5783; angfang@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 7, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)