Clinical trial NCT06173752: Mechanisms of Exposure Therapy for OCD
Official title: Leveraging Machine Learning Approaches to Understand Mechanisms of Exposure Therapy in Real-World Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Quality of Life Enjoyment & Satisfaction Questionnaire (QLES)
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Center for Understanding and Treating Anxiety
state: California
city: Belmont
country: United States
facility: McLean OCDI
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Jennie M Kuckertz, PhD
role: PRINCIPAL_INVESTIGATOR
References: