Recruiting

Exposure Therapy

Sponsor:

Mclean Hospital

Code:

NCT06173752

Conditions

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Exposure therapy

Study Details

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

Study ID

NCT06173752

Start date

Oct 16, 2024

Status verified date

Jun, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Exposure therapy

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

Primary outcome measure

  • Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Up to 12 weeks ]

Central Contacts and Locations

Central contacts

Jennie M Kuckertz, PhD

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

Locations

Center for Understanding and Treating Anxiety

Recruiting

San Diego, California, United States, 92120

Contacts

Olivia Wallace, BS

619-229-3740owallace@sdsu.edu

Principal Investigator:

Nader Amir, PhD

McLean OCDI

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Paisley Annes, BA

617-855-4395pannes@mgb.org

Principal Investigator:

Jennie M Kuckertz, PhD

More Information

Sponsor

Mclean Hospital

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2026-06-25.