Process-based Therapy vs. Routine-CBT for Difficult-to-treat Anxiety Disorders and Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Depression Anxiety Stress Scale (DASS-21)
研究概览
简要总结
The aim of this study is to test the relative efficacy of Process-based Therapy compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.
详细描述
Process-based Therapy (PBT) is a new framework to intervention planning, based on the use of ecological momentary assessment (EMA) data, feedback of dynamic network analysis and matching of interventions to central nodes of the network. Although preliminary support for its applicability has been reported from a single-case study, there are no data on the feasibility and effectiveness in a larger clinical sample. The investigators have translated a Training Manual of PBT and modified for delivery of CBT in Mental Health Service. The aim of this study is to test the relative efficacy of PBT compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.
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
- 否
入选标准
- •A primary DSM-5 diagnosis of depressive or anxiety disorder
- •At least two unsuccessful attempts of pharmacological or psychological treatment according to the German guidelines for the treatment of depression or anxiety disorders (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF)
- •Age 18-65 years
- •Sufficient knowledge of the German language
- •Participating patients are not required to discontinue medication, but to keep medication constant over the treatment period
排除标准
- •Increased suicidality
- •Substance abuse or dependency
- •Borderline personality disorder
- •Pervasive developmental disorder
- •Psychotic disorder
- •Eating disorder
- •Bipolar disorder
- •Severe physical illness
结局指标
主要结局
Depression Anxiety Stress Scale (DASS-21)
时间窗: Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up
Emotional distress, minimum value=0, maximum value=63, higher scores mean worse outcome
次要结局
- Reflective Functioning Questionnaire (RFQ-8)(Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up)
- Acceptance and Action Questionnaire Version 2 (AAQ-2)(Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up)
- Positive-Mental Health Scale (PMH)(Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up)
- Depression Anxiety Stress Scale (DASS-10)(Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up)
- Euroqol-5D (EQ-5D)(Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up)
- Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)(Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up)
- Client Satisfaction Questionnaire (CSQ-8)(Assessed at post-treatment at week 32)
- Process-based Assessment Tool (PBAT)(Assessed at inclusion, at pre-treatment, at post-treatment (week 32) and at 6 month follow-up)
- Cognitive-Behavioral-Therapy Skills Questionnaire (CBTSQ)(Assessed at inclusion, pre-treatment, weekly during the treatment (from week 11 to 30), at post-treatment (week 32) and at 6 month follow-up)
研究者
Prof. Dr. Ulrich Stangier
Director of the Department of Clinical Psychology and Psychotherapy and Center for Psychotherapy
Goethe University