Stepped Care for Obsessive-Compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score
研究概览
简要总结
This study will determine the effectiveness and cost-effectiveness of a stepped-care treatment program for people with obsessive-compulsive disorder.
详细描述
Obsessive-Compulsive Disorder (OCD) is a chronic and debilitating anxiety disorder. People with OCD often experience recurrent unwanted thoughts, called obsessions, and repetitive behaviors, called compulsions. These thoughts and behaviors interfere with everyday life to a great extent. Currently, the most frequently used psychosocial treatment for OCD is cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP). However, although effective, this treatment approach is largely inaccessible, time-consuming, labor-intensive, and expensive. A stepped-care approach to treating OCD may be more cost-effective and therefore more accessible for many individuals. Stepped-care CBT begins with the least expensive, least intrusive, most accessible option, and works up to the most expensive option if the less intrusive treatments do not work. This study will determine the benefits and cost-effectiveness of a stepped care treatment program for OCD.
Participants in this open label study will be randomly assigned to receive CBT for 6 to 14 weeks either through the stepped-care approach or immediately upon study entry. Participants will report to the study site for treatments and assessments on a regular basis, ranging from every 2 weeks to twice a week, depending on the stage of the study and the assigned treatment group. Stepped-care CBT will begin with self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement. If ineffective, this treatment will be followed by therapist-administered EX/RP. OCD symptoms will be assessed at Week 6. Participants who have responded to treatment after 6 weeks will not receive further treatment. All others will continue for an additional 8 weeks. These participants' OCD symptoms will be assessed again at Week 14. Participants assigned to the stepped-care approach whose OCD symptoms improved initially, but relapsed without further treatment by the Week 14 evaluation will receive full-scale CBT. Outcomes will be assessed again at 1- and 3-month follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of OCD of moderate or greater severity
- •Presence of OCD symptoms for at least 1 year
排除标准
- •History of psychotic or developmental disorder
- •Uncontrolled bipolar disorder
- •Serious suicide risk
- •Prior history of adequate CBT, including exposure and response prevention
研究组 & 干预措施
Traditional CBT
Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)
干预措施: Traditional CBT (Behavioral)
Stepped-Care CBT
Stepped-care CBT
干预措施: Stepped-Care CBT (Behavioral)
结局指标
主要结局
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score
时间窗: Pretreatment, Posttreatment, and 3-month follow-up
The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score was used as the outcome measure. The Y-BOCS is a clinician-rated scale assessing obsession (5 items) and compulsion (5 items) symptom severity on a 0 to 4 scale. All 10 items are added for the total score, with total scores ranging from 0 to 40, and higher numbers indicating more severe symptoms.
Treatment-related Total Cost Estimates
时间窗: Posttreatment
total estimated costs calculated based upon the fixed-dose schedule
次要结局
未报告次要终点
研究者
David Tolin
Principal Investigator
Hartford Hospital
