Precision Analytic Research Methods in OCD

NCT07011901 | Recruiting

• 2 other identifiers: STUDY-24-01125K23MH133997
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Psychiatric disorders characterized by compulsivity, such as obsessive-compulsive disorder (OCD), result in considerable functional impairment and many individuals do not respond to gold-standard treatments. Compulsivity has long been thought to occur due to exaggerated habits and reduced goal-directed control, although more recently, this conceptualization of compulsivity as an imbalance of two cognitive systems has been challenged as overly narrow. This study will recruit 100 individuals (50 adults diagnosed with OCD, 50 healthy controls) and leverage the measurement precision offered by theory-driven computational modeling in combination with electroencephalogram (EEG) to go beyond this binary theory of compulsivity, revealing how more complex interactions of neurocognitive subcomponents contribute to compulsivity-information that could ultimately lead to improved treatment personalization and clinical outcomes.

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive Disorder; Exposure and response prevention; Cognitive Behavioral Therapy; Electroencephalogram

Outcome Measures

Primary Outcomes (1)

• Yale Brown Obsessive Compulsive Scale

  A semi-structured clinician-administered instrument used to measure obsessions and compulsions separately over five dimensions (time consumed, distress, interference, degree of resistance, control). The range of scores for the Obsessions and Compulsions subscales is 0-20, and the range for the total score is 0-40. Higher scores indicate greater symptom severity, and a total score greater or equal to 16 is considered indicative of moderately severe OCD

  Week 1, Week 5, Week 10

Secondary Outcomes (4)

• Obsessive Compulsive Inventory- Revised

  Week 1, Week 5, Week 10

• Cambridge-Chicago Compulsivity Trait Scale

  Week 1, Week 5, Week 10

• Self-Report Habit Index

  Week 1, Week 5, Week 10

• Dimensional Obsessive- Compulsive Scale

  Week 1, Week 5, Week 10

Study Arms (2)

Participants diagnosed with OCD

EXPERIMENTAL

All participants diagnosed with Obsessive Compulsive Disorder (OCD) who enroll in this study will receive 17 sessions of exposure and response prevention, a specialized cognitive behavioral therapy for OCD, over the course of 10 weeks.

Behavioral: Exposure and Response Prevention

Healthy controls

NO INTERVENTION

Individuals who do not have a current or lifetime psychiatric diagnosis will not receive any treatment.

Interventions

Exposure and Response Prevention BEHAVIORAL

Exposure and response prevention (EX/RP) is the gold-standard behavioral treatment for OCD. It involves confronting the content of obsessions (distressing thoughts, images, or impulses) and resisting the urge to engage in compulsions (observable behaviors or mental acts that are repeated to reduce the anxiety/distress associated with compulsions).

Participants diagnosed with OCD

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be:
• between the ages 18-55 years old
• English-speaking
• right-handed
• able to provide consent

You may not qualify if:

• Individuals diagnosed with OCD will be excluded if:
• they meet diagnostic criteria for certain other psychiatric disorders
• are taking psychiatric medication or have received behavioral treatment for OCD within a certain timeframe
• if it is unsafe for them to participate in research
• Healthy control participants will be excluded if:
• they have a current psychiatric disorder
• a lifetime history of certain psychiatric disorders
• are taking psychiatric medication or have in the past
• have a parent or sibling who has been diagnosed with OCD
• if it is unsafe for them to participate in research

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Amy Rapp, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Rapp, Ph.D.

CONTACT

212-241-5288; OCDResearch@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Deidentified data will be deposited to the Open Science Framework (OSF) and the NIMH Data Archive (NDA), in line with data sharing requirements stipulated by the NIMH. In addition to the patient level data, experimental task design specifications will be shared to OSF and posted on the Principal Investigator's (Amy Rapp) GitHub page. A data dictionary will be uploaded to the NDA. Researchers who are interested in obtaining data from this study to submit a written request which would allow access for one year and would be renewable. Deidentified data will be stored indefinitely in the NDA.
• Access Criteria: Researchers who provide a methodologically sound proposal will be given access to deindentified study data needed to achieve aims in the approved proposal. Data will be available indefinitely at site link (to be determined).

Locations

US (1)