Interpretation Bias as a Mechanism of Treatment Response in OCD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Change in Average Score on Yale-Brown Obsessive Compulsive Scale
研究概览
简要总结
This study will conduct a randomized controlled trial of Cognitive Bias Modification for Interpretation (CBM-I) as an augmentation to treatment as usual for obsessive compulsive disorder (OCD). CBM-I is a digital intervention designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I.
Adults with obsessive compulsive disorder (OCD) will be recruited from a treatment program for this disorder and participants will be randomly assigned to either receive: 1) up to 12 sessions of CBM-I, or or up to 12 sessions of psychoeducation as a control condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •1) OCD Institute patients
- •2) adults (> 18 years old)
- •3) able to complete a computer task for 20 minutes
- •4) consent to main OCD Institute study protocol
- •5) primary diagnosis of OCD (as measured by a score of >16 on the Y-BOCS and a clinical diagnosis of OCD by their treatment team
- •6) score of >131 on the Obsessive Beliefs Questionnaire-44 at admission [which is 1 SD above the mean score of the non-clinical sample reported in the original validation paper by the Obsessive Compulsive Cognitions Working Group (2005)]
排除标准
- •1) Currently experiencing acute symptoms of psychosis
- •2) Psychotic disorder diagnosis
研究组 & 干预措施
Psychoeducation with treatment as usual
Participants in this group will receive usual treatment in the program up to 12 sessions of digitized psychoeducation
干预措施: Psychoeducation (Behavioral)
Cognitive bias modification with treatment as usual
Participants in this group will receive usual treatment in the program up to 12 sessions of a digital cognitive training targeting interpretation bias
干预措施: Cognitive bias modification for interpretation bias (Behavioral)
结局指标
主要结局
Change in Average Score on Yale-Brown Obsessive Compulsive Scale
时间窗: Weeks 0, 4, and 8
Interviewer-rated measure of OCD symptoms. It is 19 items, with only items 1-10 scored (from 0-4). Total scores range from 0-40, with higher scores reflecting greater severity.
次要结局
- Change in Average Score on Obsessive Beliefs Questionnaire(Time Frame: Weeks 0, 2, 4, and 8)
研究者
Martha J Falkenstein
Director of Research, OCD Institute
Mclean Hospital