Mechanisms of Exposure Therapy for OCD

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06173752
• Other study ID #: 2023P003369
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: April 2029

Study information

• Verified date: June 2024
• Source: Mclean Hospital
• Contact: Jennie M Kuckertz, PhD
• Phone: 617-855-2962
• Email: jkuckertz[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: April 2029
• Est. primary completion date: April 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive Compulsive Scale (YBOCS)	The YBOCS is a 10 self-report measure of OCD severity.	Up to 12 weeks
Secondary	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