Individual Versus Group Exposure and Response Prevention Therapy for the Treatment of Obsessive-Compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Yale-Brown Obsessive-Compulsive Scale
研究概览
简要总结
The primary objective is to examine the efficacy of implementing evidence based Exposure and Response Prevention (ERP) within group therapy versus individual therapy by monitoring reduction of Obsessive-Compulsive Disorder (OCD) symptomology.
详细描述
The purpose of the following study is to observe the effectiveness of group Exposure and Response Prevention verses individual Exposure and Response Prevention on patients with OCD for the use of future publications.
A total of 70 individuals will be recruited through different methods. The primary recruitment sources will be through BCM Psychiatric Clinic patient flow. Although it is anticipated that most of the study recruitment will occur through normal BCM Psychiatric Clinic patient flow, study advertisements will also be circulated through several relevant sources (e.g. BCM OCD Program website, Peace of Mind Foundation website and listserv, social media pages and OCD organizations and groups). The investigators will also contact clinicians and professionals working with OCD patients (e.g., private clinics, community organizations) in the community to distribute advertisement flyers to potential participants.
Enrollment will occur in person at Baylor College of Medicine after obtaining informed consent.
Pertinent clinical information will be collected from paper or electronic medical records. Demographics (race, ethnicity, gender, education, employment status), and health history (concomitant medical history) will be collected and entered in the database. Data entered in the database will be coded. Patient identifying information such as name, address, telephone, date of birth, and medical record number will be extracted from the medical record. A study ID will be assigned to each subject. The code linking the consented subjects' clinical information to their study ID will be stored in a password protected database. The code linking key containing patient identifying information will be kept separately from the database. Any relevant paperwork, including videos, will be stored in a locked file cabinet in the PIs office.
Prospective data collection will continue for those subjects that consent to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be adults 18 years or older.
- •Participants must have the capacity and ability to give informed consent.
- •Participants have been given an assessment and received a diagnosis of OCD.
- •Participants must speak English.
- •Participants must be able to physically attend treatment.
排除标准
- •Prisoners or any other high-risk population group.
- •experiencing active psychosis
- •experiencing active substance abuse disorder
- •experiencing active suicidality
结局指标
主要结局
Yale-Brown Obsessive-Compulsive Scale
时间窗: Post-treatment, 6 weeks after baseline
Participant OCD severity is measured with Yale-Brown Obsessive-Compulsive Scale over the course of their time in the study. Severity is measured at baseline (week 1), mid (week 3), and post (week 6) participation in ERP over the course of 6 weeks. Severity on the scale is measured based on a score range of 0-40. Participants with scores of 0-13 are considered to have mild symptoms. Scores of 14-25 are considered moderate. 26-34 are considered to be moderate-severe. 35-40 are considered to be very severe.
次要结局
未报告次要终点
研究者
Eric Alan Storch
Professor, Psychiatry Research
Baylor College of Medicine