Exposure and Response Prevention Therapy for Obsessive-Compulsive Disorder

Overseen By Jihoon Kim, MD, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Neurological disorders, MRI contraindications, Pregnancy, Suicidal ideation, Psychotic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Conor Liston, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with OCD by a clinician.

I am between 10 and 17 years old.

* Participant has sufficient English fluency to complete cognitive tasks and assessments. Parent or guardian English fluency is not required; interpreter support is available.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 14 weekly ERP sessions, including clinical assessments and MRI scans

14 weeks

14 visits (in-person or virtual)

Booster Sessions

Participants receive planned monthly ERP booster sessions and additional sessions if symptoms worsen

48 weeks

3 planned visits (in-person or virtual), additional as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, including symptom assessments and MRI scans

Up to 62 weeks

Regular visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Exposure and Response Prevention Therapy

How Is the Trial Designed?

Group I: Exposure and Response Prevention Therapy Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+