Clinical trial NCT06678295: Individual Factors of CBT Underlying Success
Official title: Contributions of Self-Focused Attention to Early Warning Indicators of Cognitive Behavioral Therapy Non-Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-11-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Trait SFA assessed by the Public Self-Consciousness Scale- Revised (SCS-R)
timeFrame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment
measure: Functional connectivity between the Default Mode and Dorsal Attention Networks (DMN-DAN)
timeFrame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment
measure: Anxiety symptom severity, assessed by the Structured Interview Guide for Hamilton Anxiety Scale (SIGH-A) and the Generalized Anxiety Disorder (GAD-7)
timeFrame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment
measure: Anxiety symptom severity, assessed by the Generalized Anxiety Disorder (GAD-7)
timeFrame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment
measure: Symptom severity associated with primary disorder, assessed by self-report versions of the Liebowitz Social Anxiety Scale (LSAS SR).
timeFrame: 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
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).
timeFrame: 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
measure: DSM5 Cross Cutting Form
timeFrame: 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:
measure: Trait rumination assessed by the Ruminative Responses Scale (RRS)
timeFrame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment
measure: Trait worry assessed by the Penn State Worry Questionnaire (PSWQ)
timeFrame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment
measure: Reaction times during Self trials in Self-Other Task
timeFrame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment
measure: Alerting, orienting, and attentional control reaction time scores on the Attention Network Test (ANT)
timeFrame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment
measure: Depression severity, as assessed by the Quick Inventory of Depressive Symptomatology (QIDS-SR)
timeFrame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment
measure: Depression severity, as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Across the span of 3 1/2 months: PHQ-9: Baseline (T-2weeks), Repeat Baseline (T0), and Weekly starting from Week 1.
measure: Insight, as assessed by the Brown Assessment of Beliefs Scale (BABS)
timeFrame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment
measure: Disability, assessed by the Sheehan Disability Scale (SDS).
timeFrame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment.
measure: Disability, assessed by the World Health Organization Disability Assessment Schedule (WHODAS)
timeFrame: Across the span of 3 1/2 months: Baseline (T-2 weeks), Repeat Baseline (T0), Post-treatment
measure: Homework compliance, assessed by a modified version of the Patient Exposure/Response Prevention Adherence Scale (PEAS)
timeFrame: Weekly starting from Week 1 to Week 12
measure: Credibility and expectancies for treatment, assessed by the Credibility and Expectancies Questionnaire (CEQ)
timeFrame: Week 3
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Angela Fang, PhD
role: PRINCIPAL_INVESTIGATOR
References: