Precision Brain Mapping to Predict and Track Response to Exposure and Response Prevention Therapy in Youth With Obsessive-Compulsive Disorder

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07570108
Status
Not Yet Recruiting

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Conditions

  • Obsessive-Compulsive Disorder

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Exposure and Response Prevention Therapy — BEHAVIORAL
    Exposure and response prevention (ERP) is an evidence-based form of cognitive behavioral therapy for obsessive-compulsive disorder. ERP involves graded exposure to obsession-triggering cues while supporting participants in refraining from compulsive responses. In this study, participants receive 14 planned weekly ERP sessions of approximately 60 minutes each, followed by three scheduled monthly booster sessions and optional symptom-triggered booster sessions during the maintenance phase. ERP may be delivered in person or by HIPAA-compliant telehealth.
  • Clinical Assessments — OTHER
    Participants complete repeated clinical assessments according to the study schedule to evaluate obsessive-compulsive disorder symptom severity, symptom change, functioning, safety, and related clinical outcomes over time. Assessments may include clinician-administered ratings, participant-report measures, and other study outcome measures. These assessments are conducted for research and clinical monitoring purposes and are not intended as a therapeutic intervention.
  • Research MRI Sessions — DIAGNOSTIC_TEST
    Participants complete research magnetic resonance imaging sessions at scheduled study time points to acquire structural and functional MRI data, including functional MRI measures used to evaluate brain connectivity over time. Imaging sessions are used to examine changes in brain circuitry in relation to obsessive-compulsive disorder symptoms and treatment course. These sessions are conducted for research measurement purposes and are not intended to provide clinical diagnosis or treatment.

Study Details

The goal of this clinical trial is to learn whether brain scan results can help predict and track changes in obsessive-compulsive disorder, or OCD, symptoms in children and teens ages 10 to 17 who receive Exposure and Response Prevention therapy, also called ERP. ERP is a type of therapy in which participants practice facing OCD-related fears while resisting rituals or compulsions. The main question this study aims to answer is: Can each participant's pattern of brain connections, measured with functional MRI brain scans, help predict and track weekly changes in OCD symptoms during and after a 14-week course of ERP, including during planned monthly booster sessions and additional booster sessions offered if symptoms worsen? All participants will receive ERP. There is no placebo and no comparison group. Participants will: * Complete screening, consent or assent, interviews, questionnaires, and MRI safety checks * Receive 14 weekly ERP sessions * Complete OCD symptom assessments and functional MRI brain scans before, during, and after ERP * Receive planned monthly ERP booster sessions after the 14 weekly sessions * Receive additional brief ERP booster sessions if OCD symptoms worsen during follow-up * Take part for up to about 62 weeks

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2030
Completion
Aug 31, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Exposure and Response Prevention Therapy
    Participants receive exposure and response prevention (ERP) therapy, an evidence-based form of cognitive behavioral therapy for obsessive-compulsive disorder. Participants also receive repeated clinical assessments and research MRI sessions. ERP consists of 14 weekly sessions of approximately 60 minutes each, followed by three scheduled monthly booster sessions and optional symptom-triggered booster sessions during the maintenance phase. ERP may be delivered in person or by HIPAA-compliant telehealth. Clinical assessments are used to measure OCD symptoms and related outcomes over time, and MRI sessions are used to evaluate brain connectivity.

Primary Outcome Measure

Association Between CY-BOCS-II Total Score and Orbitofrontal Cortex-Ventral Striatum Resting-State Functional Connectivity During Acute ERP [ Time Frame: Baseline through end-of-acute ERP assessment visit, targeted Week 14 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NewYork-Presbyterian Hospital / Weill Cornell MedicineNew YorkNew York10065
Andrei Gangal
[email protected]
212-746-3663
Conor Liston, MD, PhD (PRINCIPAL_INVESTIGATOR)
Jihoon Kim, MD, MSc (SUB_INVESTIGATOR)

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By research site
NewYork-Presbyterian Hospital / Weill Cornell Medicine· New York, NY

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