Leveraging Machine Learning Approaches to Understand Mechanisms of Exposure Therapy in Real-World Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Yale-Brown Obsessive Compulsive Scale (YBOCS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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:
- Complete an Exposure Feedback Form
- 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.
干预措施: Exposure therapy (Behavioral)
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale (YBOCS)
时间窗: Up to 12 weeks
The YBOCS is a 10 self-report measure of OCD severity.
次要结局
- Quality of Life Enjoyment & Satisfaction Questionnaire (QLES)(Up to 12 weeks)
研究者
Jennie M. Kuckertz, PhD
Research Psychologist
Mclean Hospital