Cognitive Bias Modification as an Adjunctive Treatment for Treatment-Refractory OCD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in Average Score on Obsessive Beliefs Questionnaire
研究概览
简要总结
This study will conduct the development and preliminary evaluation of Cognitive Bias Modification for Interpretation (CBM-I) and Approach Avoidance Training (AAT) as augmentations to treatment as usual for OCD and related disorders. CBM-I refers to computerized interventions designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. In AAT, automatic approach tendencies toward feared stimuli are re-trained. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I and AAT.
Adults with obsessive compulsive disorder (OCD) and related disorders will be recruited from a treatment program for these disorders and participants will be randomly assigned to either receive: 1) eight sessions of CBM-I or eight sessions of psychoeducation as a control condition, or 2) AAT or eight sessions of an inactive (sham) version of the AAT training.
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
- Triple (Participant, Investigator, 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
- •Currently receiving treatment at the McLean Hospital OCD Institute
- •For CBM-I condition only: report a score of at least 131 on the Obsessive Beliefs Questionnaire-44 upon admission to the OCD Institute
- •For AAT condition only: endorse score of at least 7 on the DOCS subscale #1 (contamination subscale) upon admission to the OCD Institute
- •Able to complete a computer task for 20 minutes
- •Consent to main OCD Institute study protocol
排除标准
- •Currently undergoing electroconvulsive therapy (ECT)
- •Current symptoms of acute mania or psychosis
- •A reported diagnosis at admission of a psychotic disorder
- •History of traumatic brain injury
结局指标
主要结局
Change in Average Score on Obsessive Beliefs Questionnaire
时间窗: Weeks 0, 2, 4, and 8
Measure of interpretation biases, specifically: Inflated Responsibility/Overestimation of Threat, Perfectionism/Intolerance of Uncertainty, and Importance/Control of Thoughts. 44-item self-report measure, items scored 1-7 and summed; greater scores indicate greater severity.
次要结局
- Change in Average Score on Yale-Brown Obsessive Compulsive Scale(Weeks 0, 4, and 8)
- Exit Interview(Week 4)
- Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales(Weeks 0, 2, 4, and 8)
- Dimensional Obsessive-Compulsive Scale(Weeks 0, 2, 4, and 8)
- Change in Suicide Implicit Association Test(Weeks 0, 2, and 4)
- Change in Columbia-Suicide Severity Rating Scale(Weeks 0, 4, and 8)
- Change in Behavioral Approach Test(Weeks 0, 2, and 4)
- Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity.(Weeks 0, 1, 2, 3, and 4)
- Credibility/Expectancy Questionnaire(Week 0)
研究者
Martha J Falkenstein
Staff Psychologist
Mclean Hospital