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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorWeill Medical College of Cornell University

About 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

Eligibility criteria

Qualifiers

Age 10 to 17 years at the time of initial consent. Participants who reach age 18 while enrolled may remain in the study after completing the adult re-consent process; no new participants age 18 years or older will be recruited.

DSM-5 diagnosis of obsessive-compulsive disorder, established through a clinical interview by a clinician.

Parent or guardian able to provide informed consent and participant able to provide assent.

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

Disqualifiers

History or current evidence of a significant neurological disorder, including but not limited to seizure disorder, stroke, or traumatic brain injury with loss of consciousness.

Any standard MRI contraindication identified during initial screening or on the MRI safety checklist, including but not limited to ferromagnetic implants, certain medical devices or metal fragments, severe claustrophobia, or pregnancy.

Pregnancy at screening or pregnancy identified during study participation.

Active suicidal ideation.

Trial design

Treatments tested in this trial

  • Exposure and Response Prevention Therapy
  • Clinical Assessments
  • Research MRI Sessions

Treatment groups

30 Participants
are divided into 1 treatment group