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Social Anxiety DisorderI-FOCUSNCT06678295

Individual Factors of CBT Underlying Success

A study testing Cognitive Behavioral Therapy in people with Social Anxiety Disorder and Body Dysmorphic Disorder, run by University of Washington at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
15 Oct 2024to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Angela Fang, PhD contact

(206) 616-5783

angfang@uw.edu

United States1 site, 1 recruiting
  • University of Washington

    Seattle, Washington, 98105

    Randhara Kotuwelle, B.A., 206-221-1278, ifocuscbt@uw.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Keywords
Body Dysmorphic Disorder, Social Anxiety Disorder, Social Phobia, Self focused attention, fMRI, CBT, Cognitive Behavior Therapy, BDD, SAD, Neuroimaging
Medical subject headings
Phobia, Social, Body Dysmorphic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06678295
Study groupRoleWhat they receive
Cognitive behavioral therapyExperimentalTwelve weekly sessions of individual cognitive behavioral therapy
Receives: Behavioral: Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trait SFA assessed by the Public Self-Consciousness Scale- Revised (SCS-R)

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

    Measured: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment

  2. Functional connectivity between the Default Mode and Dorsal Attention Networks (DMN-DAN)

    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.

    Measured: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment

  3. Anxiety symptom severity, assessed by the Structured Interview Guide for Hamilton Anxiety Scale (SIGH-A) and the Generalized Anxiety Disorder (GAD-7)

    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

    Measured: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment

  4. Anxiety symptom severity, assessed by the Generalized Anxiety Disorder (GAD-7)

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

    Measured: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment

  5. Symptom severity associated with primary disorder, assessed by self-report versions of the Liebowitz Social Anxiety Scale (LSAS SR).

    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.

    Measured: 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

  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).

    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.

    Measured: 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

  7. DSM5 Cross Cutting Form

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

    Measured: 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 (11)
  1. Trait rumination assessed by the Ruminative Responses Scale (RRS)

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

    Measured: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment

  2. Trait worry assessed by the Penn State Worry Questionnaire (PSWQ)

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

    Measured: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment

  3. Reaction times during Self trials in Self-Other Task

    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.

    Measured: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment

  4. Alerting, orienting, and attentional control reaction time scores on the Attention Network Test (ANT)

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

    Measured: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment

  5. Depression severity, as assessed by the Quick Inventory of Depressive Symptomatology (QIDS-SR)

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

    Measured: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment

  6. Depression severity, as assessed by the Patient Health Questionnaire-9 (PHQ-9)

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

    Measured: Across the span of 3 1/2 months: PHQ-9: Baseline (T-2weeks), Repeat Baseline (T0), and Weekly starting from Week 1.

  7. Insight, as assessed by the Brown Assessment of Beliefs Scale (BABS)

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

    Measured: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment

  8. Disability, assessed by the Sheehan Disability Scale (SDS).

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

    Measured: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment.

  9. Disability, assessed by the World Health Organization Disability Assessment Schedule (WHODAS)

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

    Measured: Across the span of 3 1/2 months: Baseline (T-2 weeks), Repeat Baseline (T0), Post-treatment

  10. Homework compliance, assessed by a modified version of the Patient Exposure/Response Prevention Adherence Scale (PEAS)

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

    Measured: Weekly starting from Week 1 to Week 12

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

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

    Measured: Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2024
  2. Study start15 Oct 2024
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06678295
Sponsor's protocol ID
STUDY00019785
Other IDs
R01MH133581
Acronym
I-FOCUS
Status last verified
Feb 2026
First submitted
29 Oct 2024
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy in people with Social Anxiety Disorder and Body Dysmorphic Disorder, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Angela Fang, PhD ((206) 616-5783, angfang@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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