Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06678295

Individual Factors of CBT Underlying Success

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Body Dysmorphic Disorder Body Dysmorphic Disorders Mental Disorders Phobia, Social Phobic Disorders Somatoform Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98105, United States

Location status: Recruiting

Location contact

Randhara Kotuwelle, B.A.

CONTACT

[email protected]

206-221-1278

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)
  • 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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

Twelve weekly sessions of individual cognitive behavioral therapy

Primary outcomes

  1. 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

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

  2. 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

    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.

  3. 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

    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

  4. 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

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

  5. 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

    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.

  6. 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

    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.

  7. 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

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

Secondary outcomes

  1. 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

    Participants will complete the 22-item self-report RRS measure to assess trait levels of rumination.

  2. 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

    Participants will complete the 16-item self-report PSWQ measure to assess trait worry.

  3. 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

    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.

  4. 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

    Participants will complete the Attention Network Test, which is a well-validated neurocognitive assay of general attentional mechanisms (alerting, orienting, and attentional control).

  5. 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

    The QIDS SR is a 16-item self-report measure of depressive symptom severity.

  6. 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.

    The Patient Health Questionnaire-9 (PHQ-9) is a 9-item, self-report measure of depression

  7. 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

    The BABS is a 7-item clinician-rated instrument of insight and delusionality designed to assess delusions across a wide range of disorders.

  8. 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.

    The SDS is a 5-item self-report measure of disability in work/school, social life, and family life.

  9. 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

    The WHODAS is a 12-item self-report measure of health-related difficulties

  10. 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

    The Modified PEAS is a therapist-rated measure of homework compliance for exposure and nonexposure-related homework

  11. Credibility and expectancies for treatment, assessed by the Credibility and Expectancies Questionnaire (CEQ)

    Time frame: Week 3

    The CEQ is a 6-item self-report measure of patient's beliefs about the credibility of treatment and expectancies for treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Fang, PhD

CONTACT

[email protected]

(206) 616-5783

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: I-FOCUS

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 7, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.