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

NCT07570108 | Not Yet Recruiting

• 1 other identifier: 25-12029657
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-compulsive disorder; Pediatric obsessive-compulsive disorder; OCD; Pediatric OCD; Exposure and response prevention; ERP; Cognitive behavioral therapy; Functional magnetic resonance imaging; Resting-state functional connectivity; Precision functional mapping; Longitudinal neuroimaging; Treatment response biomarker

Outcome Measures

Primary Outcomes (1)

• Association Between CY-BOCS-II Total Score and Orbitofrontal Cortex-Ventral Striatum Resting-State Functional Connectivity During Acute ERP

  The primary outcome is the within-participant association between obsessive-compulsive disorder symptom severity and resting-state functional connectivity during the acute ERP phase. OCD symptom severity will be measured using the Children's Yale-Brown Obsessive Compulsive Scale, Second Edition total score. OFC-ventral striatum resting-state functional connectivity will be measured using Fisher z-transformed resting-state fMRI connectivity. The association will be estimated using visit-level linear mixed-effects models. CY-BOCS-II total scores range from 0 to 50, with higher scores indicating greater OCD symptom severity.

  Baseline through end-of-acute ERP assessment visit, targeted Week 14

Secondary Outcomes (4)

• Change From Baseline in CY-BOCS-II Total Score at End of Acute ERP

  Baseline to end-of-acute ERP assessment visit, targeted Week 14

• Number of Participants With Treatment-Emergent Adverse Events

  From first study procedure through last study visit, up to 62 weeks

• Change in CY-BOCS-II Total Score From End of Acute ERP to Last Booster or Maintenance Visit

  End-of-acute ERP assessment visit, targeted Week 14, to last booster or maintenance clinical assessment visit, up to Week 62

• Change in OFC-Ventral Striatum Resting-State Functional Connectivity From End of Acute ERP to Last Booster or Maintenance Imaging Visit

  End-of-acute ERP imaging visit, targeted Week 14, to last booster or maintenance imaging visit, up to Week 62

Study Arms (1)

Exposure and Response Prevention Therapy

EXPERIMENTAL

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.

Behavioral: Exposure and Response Prevention Therapy; Other: Clinical Assessments; Diagnostic Test: Research MRI Sessions

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.

Also known as: Exposure and Response Prevention, ERP

Exposure and Response Prevention Therapy

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.

Exposure and Response Prevention Therapy

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.

Exposure and Response Prevention Therapy

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Any psychiatric condition that, in the investigator's judgment, would interfere with study participation or data interpretation, including but not limited to psychotic disorders, bipolar disorders, severe neurodevelopmental disorders, intellectual disability, severe eating disorders, or recent significant substance use disorders within the past 6 months. Stable psychiatric comorbidities, including anxiety disorders, depressive disorders, ADHD, or tic disorders, are permitted if OCD remains the primary diagnosis.
• Any medical, psychiatric, or situational factor judged by the investigator as likely to compromise participant safety, adherence, or data integrity.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

NewYork-Presbyterian Hospital / Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (8)

• Jaspers-Fayer F, Lin SY, Chan E, Ellwyn R, Lim R, Best J, Belschner L, Lang D, Heran MKM, Woodward TS, Stewart SE. Neural correlates of symptom provocation in pediatric obsessive-compulsive disorder. Neuroimage Clin. 2019;24:102034. doi: 10.1016/j.nicl.2019.102034. Epub 2019 Oct 23.

  PMID: 31734533 BACKGROUND

• Scahill L, Riddle MA, McSwiggin-Hardin M, Ort SI, King RA, Goodman WK, Cicchetti D, Leckman JF. Children's Yale-Brown Obsessive Compulsive Scale: reliability and validity. J Am Acad Child Adolesc Psychiatry. 1997 Jun;36(6):844-52. doi: 10.1097/00004583-199706000-00023.

  PMID: 9183141 BACKGROUND

• Lynch CJ, Elbau IG, Ng T, Ayaz A, Zhu S, Wolk D, Manfredi N, Johnson M, Chang M, Chou J, Summerville I, Ho C, Lueckel M, Bukhari H, Buchanan D, Victoria LW, Solomonov N, Goldwaser E, Moia S, Caballero-Gaudes C, Downar J, Vila-Rodriguez F, Daskalakis ZJ, Blumberger DM, Kay K, Aloysi A, Gordon EM, Bhati MT, Williams N, Power JD, Zebley B, Grosenick L, Gunning FM, Liston C. Frontostriatal salience network expansion in individuals in depression. Nature. 2024 Sep;633(8030):624-633. doi: 10.1038/s41586-024-07805-2. Epub 2024 Sep 4.

  PMID: 39232159 BACKGROUND

• Gordon EM, Laumann TO, Gilmore AW, Newbold DJ, Greene DJ, Berg JJ, Ortega M, Hoyt-Drazen C, Gratton C, Sun H, Hampton JM, Coalson RS, Nguyen AL, McDermott KB, Shimony JS, Snyder AZ, Schlaggar BL, Petersen SE, Nelson SM, Dosenbach NUF. Precision Functional Mapping of Individual Human Brains. Neuron. 2017 Aug 16;95(4):791-807.e7. doi: 10.1016/j.neuron.2017.07.011. Epub 2017 Jul 27.

  PMID: 28757305 BACKGROUND

• Pauls DL, Abramovitch A, Rauch SL, Geller DA. Obsessive-compulsive disorder: an integrative genetic and neurobiological perspective. Nat Rev Neurosci. 2014 Jun;15(6):410-24. doi: 10.1038/nrn3746.

  PMID: 24840803 BACKGROUND

• McGuire JF, Piacentini J, Lewin AB, Brennan EA, Murphy TK, Storch EA. A META-ANALYSIS OF COGNITIVE BEHAVIOR THERAPY AND MEDICATION FOR CHILD OBSESSIVE-COMPULSIVE DISORDER: MODERATORS OF TREATMENT EFFICACY, RESPONSE, AND REMISSION. Depress Anxiety. 2015 Aug;32(8):580-93. doi: 10.1002/da.22389. Epub 2015 Jun 30.

  PMID: 26130211 BACKGROUND

• Pediatric OCD Treatment Study (POTS) Team. Cognitive-behavior therapy, sertraline, and their combination for children and adolescents with obsessive-compulsive disorder: the Pediatric OCD Treatment Study (POTS) randomized controlled trial. JAMA. 2004 Oct 27;292(16):1969-76. doi: 10.1001/jama.292.16.1969.

  PMID: 15507582 BACKGROUND

• Practice parameter for the assessment and treatment of children and adolescents with obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 2012 Jan;51(1):98-113. doi: 10.1016/j.jaac.2011.09.019.

  PMID: 22176943 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Conor Liston, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jihoon Kim, MD, MSc

CONTACT

862-414-3322; gmj9009@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, open-label behavioral intervention study in which all enrolled participants receive exposure and response prevention therapy and undergo repeated clinical and neuroimaging assessments. There is no randomization, comparator group, crossover, or factorial assignment.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): August 1, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)