Individual Factors of CBT Underlying Success

Official title

Contributions of Self-Focused Attention to Early Warning Indicators of Cognitive Behavioral Therapy Non-Response

Overview

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.

Interventions

• Behavioral Cognitive Behavioral Therapy
  Twelve weekly sessions of individual cognitive behavioral therapy

Primary outcome measures

• 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]

Secondary outcome measures (11)

• Trait rumination assessed by the Ruminative Responses Scale (RRS) [Time frame: 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) [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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 Patient Health Questionnaire-9 (PHQ-9) [Time frame: Across the span of 3 1/2 months: PHQ-9: Baseline (T-2weeks), Repeat Baseline (T0), and Weekly starting from Week 1.]
• Insight, as assessed by the Brown Assessment of Beliefs Scale (BABS) [Time frame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment]
• Disability, assessed by the Sheehan Disability Scale (SDS). [Time frame: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment.]
• Disability, assessed by the World Health Organization Disability Assessment Schedule (WHODAS) [Time frame: Across the span of 3 1/2 months: Baseline (T-2 weeks), Repeat Baseline (T0), Post-treatment]
• Homework compliance, assessed by a modified version of the Patient Exposure/Response Prevention Adherence Scale (PEAS) [Time frame: Weekly starting from Week 1 to Week 12]
• Credibility and expectancies for treatment, assessed by the Credibility and Expectancies Questionnaire (CEQ) [Time frame: Week 3]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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)

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Washington — Seattle

Identifiers

NCT: NCT06678295 · STUDY00019785 · R01MH133581

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗