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临床试验/NCT00316355
NCT00316355已完成不适用

Stepped Care for Obsessive-Compulsive Disorder

Hartford Hospital2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2006年6月最近更新:
适应症
干预措施

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

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

Active Comparator

Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)

干预措施: Traditional CBT (Behavioral)

Stepped-Care CBT

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Tolin

Principal Investigator

Hartford Hospital

研究点 (2)

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