Individual Factors of CBT Underlying Success

Not Applicable

Recruiting

• Conditions: Social Anxiety Disorder; Body Dysmorphic Disorder

• Registration Number: NCT06678295
• Lead Sponsor: University of Washington

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.

Detailed Description

The investigators are conducting this research to evaluate the reliability and construct validity of measures of self-focused attention (SFA) across neural, neurocognitive, and self-report levels of analysis as well as examine whether early changes in the SFA biomarker are associated with CBT non-response.

This will be looked at in a clinical population consisting of individuals with social anxiety disorder (SAD) and body dysmorphic disorder (BDD) compared to healthy volunteers. This study employs an open clinical trial for cognitive behavioral therapy with pre-, mid- and post-treatment neuroimaging scans, clinical interviews, neurocognitive, behavioral, and self-report assessments. Clinical participants will be invovled for 3.5 months and complete 12 CBT sessions and 4 fMRI scans. Control participants will not participate in CBT treatment and will complete 3 fMRI scans across a 3.5 month period. About 160 people will take part in this research study, all at the University of Washington (UW). This will include 110 clinical participants and 50 healthy control participants.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-10-15
• Study First Submitted: 2024-10-29
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-05
• Last Update Submitted: 2024-11-05
• Study First Posted: 2024-11-07
• Last Update Posted: 2024-11-07
• Primary Completion: 2028-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

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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)

3. 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Trait SFA assessed by the Public Self-Consciousness Scale- Revised (SCS-R)	Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment	Participants will complete the 7-item self-report Public SCS-R measure to assess trait self-focused attention.
Functional connectivity between the Default Mode and Dorsal Attention Networks (DMN-DAN)	Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment	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.
Anxiety symptom severity, assessed by the Structured Interview Guide for Hamilton Anxiety Scale (SIGH-A) and the Generalized Anxiety Disorder (GAD-7)	Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment	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
Anxiety symptom severity, assessed by the Generalized Anxiety Disorder (GAD-7)	Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment	Generalized Anxiety Disorder (GAD-7) is a 7-item self-report measure of severe anxiety
Symptom severity associated with primary disorder, assessed by self-report versions of the Liebowitz Social Anxiety Scale (LSAS SR).	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	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.
Symptom severity associated with primary disorder, assessed by self-report version of the Yale-Brown Obsessive-Compulsive Scale Modified for BDD (BDD-YBOCS SR).	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	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.
DSM5 Cross Cutting Form	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	The DSM-5 Cross Cutting Measure is a 24-item self-report measure that assesses symptom related problems over the past 2 weeks.

Secondary Outcome Measures

Name	Time	Method
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	Participants will complete the 22-item self-report RRS measure to assess trait levels of rumination.
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	Participants will complete the Self-Other fMRI task and reaction time responses assessed simultaneously during fMRI will be examined as a measure of self-referential processing.
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	Participants will complete the 16-item self-report PSWQ measure to assess trait worry.
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	Participants will complete the Attention Network Test, which is a well-validated neurocognitive assay of general attentional mechanisms (alerting, orienting, and attentional control).
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	The QIDS SR is a 16-item self-report measure of depressive symptom severity.
Depression severity, as assessed by the Patient Health Questionnaire-9 (PHQ-9)	Across the span of 3 1/2 months: PHQ-9: Baseline (T-2weeks), Repeat Baseline (T0), and Weekly starting from Week 1.	The Patient Health Questionnaire-9 (PHQ-9) is a 9-item, self-report measure of depression
Insight, as assessed by the Brown Assessment of Beliefs Scale (BABS)	Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment	The BABS is a 7-item clinician-rated instrument of insight and delusionality designed to assess delusions across a wide range of disorders.
Disability, assessed by the Sheehan Disability Scale (SDS).	Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment.	The SDS is a 5-item self-report measure of disability in work/school, social life, and family life.
Disability, assessed by the World Health Organization Disability Assessment Schedule (WHODAS)	Across the span of 3 1/2 months: Baseline (T-2 weeks), Repeat Baseline (T0), Post-treatment	The WHODAS is a 12-item self-report measure of health-related difficulties
Homework compliance, assessed by a modified version of the Patient Exposure/Response Prevention Adherence Scale (PEAS)	Weekly starting from Week 1 to Week 12	The Modified PEAS is a therapist-rated measure of homework compliance for exposure and nonexposure-related homework
Credibility and expectancies for treatment, assessed by the Credibility and Expectancies Questionnaire (CEQ)	Week 3	The CEQ is a 6-item self-report measure of patient's beliefs about the credibility of treatment and expectancies for treatment.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States