Mechanisms of Exposure Therapy for OCD
Part of paid clinical trials in San Diego, California.
- Sponsor
- Mclean Hospital
- Study ID
- NCT06173752
- Status
- Recruiting
Conditions
- Obsessive-Compulsive Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Exposure therapy — BEHAVIORALParticipants will complete exposure therapy for up to 12 weeks, and coached exposure session will be approximately 50 minutes.
Study Details
Exposure therapy is the most effective treatment available for obsessive compulsive disorder, yet up to 50% of patients do not recover because the mechanisms underlying successful response are poorly understood, leading to significant variability in how clinicians conduct exposure therapy. The main purpose of this study is to determine which target mechanisms are most critical to engage in real-world exposure sessions to produce good treatment outcomes. Adult participants (N = 400) with Obsessive Compulsive Disorder (OCD) receiving exposure therapy from two sites (McLean Hospital, San Diego State University) across the continuum of care (outpatient, partial hospital, residential) will complete baseline clinical and demographic measures as well as weekly symptom reports. The project will measure exposure mechanisms across three levels of analysis (self-report, observer-rated behavior, physiology) during each exposure session. Mechanisms assessed will include a broad range of variables based on both habituation and inhibitory learning models of exposure. Self-report and observer-rated mechanisms will be measured with the Exposure Feedback Form, created and piloted by the study team. Physiological mechanisms will include skin conductance response, heart rate, and heart rate variability measured with a wristwatch. The current study will determine (1) which exposure mechanisms lead to favorable clinical outcomes, and (2) what makes a good exposure for whom. Results of this study have the potential to improve personalized care for the many patients who do not remit following exposure therapy for OCD.
Key Dates
- Start date
- Oct 16, 2024
- Status verified
- Dec 2025
- Primary completion
- Apr 30, 2029
- Completion
- Apr 30, 2029
Study Design
- Enrollment
- 400 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Exposure therapyParticipants will complete exposure therapy for up to 12 weeks, and each coached exposure session will be approximately 50 minutes. Exposure plans will be developed collaboratively between participants and their clinician at the beginning of treatment, and refined iteratively as clinically appropriate. In each coached exposure, participants will: 1. Complete an Exposure Feedback Form 2. Wear a wristwatch that provides psychophysiological data The intervention will occur across two study sites (McLean Hospital, San Diego State University). Sites will differ on level of care. At McLean Hospital, participants will be recruited from the OCD Institute and will receive exposure therapy via partial hospital or residential setting as part of their standard care, regardless of participation in the study. At San Diego State University, participants will be recruited to receive exposure therapy via outpatient setting.
Primary Outcome Measure
Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Up to 12 weeks ]
Central Contacts
- Jennie M Kuckertz, PhD617-855-2962
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Center for Understanding and Treating Anxiety | San Diego | California | 92120 | Nader Amir, PhD (PRINCIPAL_INVESTIGATOR) |
| McLean OCDI | Belmont | Massachusetts | 02478 | Jennie M Kuckertz, PhD (PRINCIPAL_INVESTIGATOR) |
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