Mechanisms of Exposure Therapy for OCD

NCT06173752 | Recruiting DMC

• 1 other identifier: 2023P003369
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive Compulsive Scale (YBOCS)

  The YBOCS is a 10 self-report measure of OCD severity.

  Up to 12 weeks

Secondary Outcomes (1)

• Quality of Life Enjoyment & Satisfaction Questionnaire (QLES)

  Up to 12 weeks

Study Arms (1)

Exposure therapy

EXPERIMENTAL

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.

Behavioral: Exposure therapy

Interventions

Exposure therapy BEHAVIORAL

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

Exposure therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (2)

Center for Understanding and Treating Anxiety

San Diego, California, 92120, United States

RECRUITING

McLean OCDI

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jennie M Kuckertz, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennie M Kuckertz, PhD

CONTACT

617-855-2962; jkuckertz@mclean.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychologist

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 18, 2023
• Study Start: October 16, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

US (2)