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Mechanisms of Exposure Therapy for OCD

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06173752
Enrollment
400
Registered
2023-12-18
Start date
2024-10-16
Completion date
2029-04-01
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-Compulsive Disorder

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.

Interventions

BEHAVIORALExposure therapy

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

Sponsors

Mclean Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Yale-Brown Obsessive Compulsive Scale (YBOCS)Up to 12 weeksThe YBOCS is a 10 self-report measure of OCD severity.

Secondary

MeasureTime frameDescription
Quality of Life Enjoyment & Satisfaction Questionnaire (QLES)Up to 12 weeksThe QLES is a 14-item self-report measure assesses the degree of enjoyment and satisfaction experienced in various daily functioning domains.

Countries

United States

Contacts

CONTACTJennie M Kuckertz, PhD
jkuckertz@mclean.harvard.edu617-855-2962
PRINCIPAL_INVESTIGATORJennie M Kuckertz, PhD

Mclean Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026