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 — BEHAVIORAL
    Participants 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 therapy
    Participants 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

Locations (2)

FacilityCityStateZIPSite coordinators
Center for Understanding and Treating AnxietySan DiegoCalifornia92120
Olivia Wallace, BS
619-229-3740
Nader Amir, PhD (PRINCIPAL_INVESTIGATOR)
McLean OCDIBelmontMassachusetts02478
Nicholas Kim, BS
617-855-4395
Jennie M Kuckertz, PhD (PRINCIPAL_INVESTIGATOR)

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