Metacognitive Therapy Versus Cognitive Behavioral Therapy for Mixed Anxiety Disorders: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Modum Bad
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version
研究概览
简要总结
Comorbidity is normal in clinical practice. Metacognitive Therapy (MCT) is a transdiagnostic model and could therefore be well suited when it comes to treating patients with high rates of comorbidity. So far, no studies have examined MCT in comparison with the best documented and evidence based treatment, cognitive behavioral treatment(CBT), in a randomized controlled trial consisting of mixed anxiety disorder sample with high degree of comorbidity.
The main aim of this study is to 1) Evaluate the effectiveness of metacognitive therapy in a sample of mixed anxiety disorders as compared to a group receiving existing evidence-based single diagnosis CBT- treatment protocols 2) Investigate patterns and mechanisms of change in the two treatments.
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
- Single (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
- 是
入选标准
- •DSM IV diagnoses of SAD, PD/A or PTSD (CSR>4)
- •Withdraw of all psychotropic medications before treatment
排除标准
- •Psychosis
- •Not willing to accept randomization
- •Comorbid conditions are in immediate need of treatment
研究组 & 干预措施
Metacognitive therapy
The treatment is based on the generic manual by Wells (2009).
干预措施: Metacognitive therapy (Behavioral)
Cognitive behavorial therapy
CBT includes the diagnose specific manuals for panic disorder (Clark, 1986), Social Phobia (Clark & Wells, 1995) and PTSD (Foa, 2007).
干预措施: Cognitive behavioral therapy (Behavioral)
结局指标
主要结局
Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version
时间窗: PRE/POST/1 year follow up
The ADIS -IV is a semistructured diagnostic interview designed to establish reliable DSM-IV anxiety, mood, somatoform and substance disorders. Interviewers assign a 0-8 clinical severity rating (CSR), that indicate their judgement of the degree of distress.
Beck Anxiety Inventory (BAI)
时间窗: PRE/POST/weekly and 1 year follow up
次要结局
- Metacognitions Questionnaire- 30 (MCQ-30; Wells & Cartwright-Hatton, 2003)(Pre/Post/weekly and 1 year follow up)
- Working Alliance Inventory (WAI; Horwath & Greenberg, 1989)(Pre/Post/weekly and 1 year follow up)
- The Repetitive Thinking Questionnaire(RTQ; McEvoy et al., 2010)(Pre/Post and 1 year follow up)
- PTSD Symptom scale Self Report (PSSR; Foa et al., 1993)(Pre/Post and 1 year follow up)
- Dysfunctional emotion regulations scale (DERS; Graz & Roemer, 2004)(Pre/Post/ and 1 year follow up)
- Cognitive attentional syndrome 1 (CAS1; Wells, 2009)(Pre/Post/weekly and 1 year follow up)
- Social Phobia Inventory (SPIN; Connor et al., 2000)(Pre/Post and 1 year follow up)
- Mobility inventory (MI; Chambless, 1985)(Pre/Post and 1 year follow up)
- The Inventory of Interpersonal Problems (IIP 64 C; Horowitz et al., 1988)(Pre/Post and 1 year follow up)
- Youngs Schema Questionnaire YSQ -75 (Young, 1998)(Pre/Post and 1 year follow up)
- SF 36(Pre/Post and 1 year follow up)
- The Symptom Checklist 90(SCL90; Derogatis et al., 1996)(Pre/Post/1 year follow up)
- The Patient Health Questionnaire depression module (PHQ 9; Spitzer et al., 1999)(Pre/Post and 1 year follow up)
- The Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger & Borkovec, 1990)(Pre/Post and 1 year follow up)