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Individual Factors of CBT Underlying Success
NCT06678295 · University of Washington
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Contributions of Self-Focused Attention to Early Warning Indicators of Cognitive Behavioral Therapy Non-Response
About this study
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.
Eligibility criteria
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 target: 160 participants
Allocation: na
Masking: none
Age groups: adult
Timeline
Starts: 2024-10-15
Estimated completion: 2028-09-30
Last updated: 2026-02-17
Interventions
Behavioral: Cognitive Behavioral Therapy
Primary outcomes
- • 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)
- • 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)
- • 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)
Sponsor
University of Washington · other
With: National Institute of Mental Health (NIMH)
Contacts & investigators
ContactAngela Fang, PhD · contact · angfang@uw.edu · (206) 616-5783
InvestigatorAngela Fang, PhD · principal_investigator, University of Washington
All locations (1)
University of WashingtonRecruiting
Seattle, Washington, United States