Individual Factors of CBT Underlying Success
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Men and women, age 18-45
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Cognitive Behavioral Therapy
BehavioralTwelve weekly sessions of individual cognitive behavioral therapy
Treatment groups
160 Participants
are divided into 1 treatment groupGroup A: Cognitive behavioral therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment2
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.
Time frame
Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment3
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
Time frame
Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment4
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
Time frame
Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatmentSecondary outcomes
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.
Time frame
Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment2
Trait worry assessed by the Penn State Worry Questionnaire (PSWQ)
Participants will complete the 16-item self-report PSWQ measure to assess trait worry.
Time frame
Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment3
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.
Time frame
Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment4
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).
Time frame
Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov