Leveraging Machine Learning Approaches to Understand Mechanisms of Exposure Therapy in Real-World Settings

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Between the ages of 18-65 years old

• Seeking exposure treatment at McLean Hospital OCD Institute or San Diego State University

• Have a diagnosis of OCD

• Able to complete study measures and treatment procedures in English

Locations
United States
California
Center for Understanding and Treating Anxiety
RECRUITING
San Diego
Massachusetts
McLean OCDI
RECRUITING
Belmont
Contact Information
Primary
Jennie M Kuckertz, PhD
jkuckertz@mclean.harvard.edu
617-855-2962
Time Frame
Start Date: 2024-10-16
Estimated Completion Date: 2029-04
Participants
Target number of participants: 400
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Mclean Hospital

This content was sourced from clinicaltrials.gov