Individual Factors of CBT Underlying Success

NCT ID: NCT06678295

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2028-09-30

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.

Conditions

Social Anxiety Disorder; Body Dysmorphic Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive behavioral therapy

Twelve weekly sessions of individual cognitive behavioral therapy

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Twelve weekly sessions of individual cognitive behavioral therapy

Interventions

Cognitive Behavioral Therapy

Twelve weekly sessions of individual cognitive behavioral therapy

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Angela Fang

Associate Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela Fang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Angela Fang, PhD

Role: CONTACT

angfang@uw.edu

(206) 616-5783

Facility Contacts

Randhara Kotuwelle, B.A.

Role: primary

ifocuscbt@uw.edu

206-221-1278

Other Identifiers

R01MH133581

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00019785

Identifier Type: -

Identifier Source: org_study_id