Mechanisms of Exposure Therapy for OCD

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Behavioral: Exposure therapy

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennie M Kuckertz, PhD; Phone Number: 617-855-2962; Email: jkuckertz@mclean.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Acute symptoms of psychosis
• Active suicidality (plan, means, intent and/or suicide attempt in past 3 months)
• Presence of co-occurring symptoms that warrant higher level of care (e.g., inpatient treatment)
• Presence of any medical, psychiatric, or developmental condition that would prevent patients from completing assessments or exposure exercises (e.g., non-verbal autism spectrum disorder)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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: Complete an Exposure Feedback Form; 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.

Behavioral: Exposure therapy; Participants will complete exposure therapy for up to 12 weeks, and coached exposure session will be approximately 50 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yale-Brown Obsessive Compulsive Scale (YBOCS)	The YBOCS is a 10 self-report measure of OCD severity.	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Enjoyment & Satisfaction Questionnaire (QLES)	The QLES is a 14-item self-report measure assesses the degree of enjoyment and satisfaction experienced in various daily functioning domains.	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Investigators: Principal Investigator: Jennie M Kuckertz, PhD, McLean Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 2023P003369

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No