NCT02867449已完成不适用
A Non-Inferiority Trial of Metacognitive Therapy Versus Exposure and Response Prevention for Individuals With Obsessive-Compulsive Disorder
University of Leipzig2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2016年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)
研究概览
简要总结
Cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder. However, the majority of treated patients remain symptomatic. The metacognitive therapy by Wells (1997) could achieve substantial gains in first pilot studies. The purpose of this study is to investigate this approach with a randomized controlled trial by comparing metacognitive therapy with exposure and response prevention for obsessive-compulsive disorder.
详细描述
The purpose of this study is to investigate metacognitive therapy by Wells (1997) with a randomized controlled trial by comparing metacognitive therapy with exposure and response prevention for obsessive-compulsive disorder.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis: obsessive-compulsive disorder
- •German-speaking
- •Agreeing to participate, verified by completion of informed consent
- •Stable medication (at least 4 weeks)
排除标准
- •Current or past diagnosis of substance dependence, psychosis, neurological conditions
- •Mental retardation
研究组 & 干预措施
Metacognitive Therapy
Experimental
Metacognitive Therapy for OCD according to Wells (1997)
干预措施: Metacognitive Therapy (Behavioral)
Exposure and Response Prevention
Experimental
Exposure and Response Prevention for OCD according to Kozak & Foa (1997)
干预措施: Exposure and Response Prevention (Behavioral)
结局指标
主要结局
Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)
时间窗: at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment)
Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)
次要结局
- Change in Symptom Severity (Padua Inventory; PI)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
- Change in Depression (Beck Depression Inventory, BDI-II)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
- Change in Symptom Severity (Clinical Global Impressions; CGI)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
- Difference in efficiency (length of treatment)(immediately after completion of therapy (after an expected avarage of 12 weeks))
- Difference in negative effects of psychotherapy (Inventory for the Assessment of Negative Effects of Psychotherapy, INEP)(after completion of 6 therapeutic sessions (after an expected avarage of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected avarage of 12 weeks), at follow-up (6 months after end of treatment))
- Difference in satisfaction with the treatment(immediately after completion of therapy (after an expected avarage of 12 weeks))
- Change in general psychopathology (Symptom Checklist-90-Revised, SCL-90-R)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
- Change in Metacognitions (Metacognitions Questionnaire, short version, MCQ-30)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
- Change in Obsessive Beliefs (Obsessive Beliefs Questionnaire, OBQ)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
- Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
- Change in Anxiety (Beck Anxiety Inventory, BAI)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
- Difference in medical costs (based on the length of treatment)(immediately after completion of therapy (after an expected avarage of 12 weeks))
- Change in psychosocial functioning (Global Assessment of Functioning Scale, GAF)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
- Change in quality of life (The World Health Organization Quality of Life, WHOQOL_BREF)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
研究者
Cornelia Exner
Prof. Dr. Cornelia Exner
University of Leipzig
研究点 (2)
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