Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 2
- 主要终点
- Time to new affective episode
研究概览
简要总结
This efficacy study compares an adjuvant specific psychotherapy and an active control intervention for Bipolar Disorder under mood stabilizer to prevent relapse an maintain remission. Patients should be in their early (18-30 yr.) phase of illness without having suffered of to many affective episodes (below 6), already. In addition, psychological, social, and neurobiological mediators and moderators well be identified.
详细描述
There is still a lack of controlled outcome and follow-up studies about the role of adjuvant psychotherapy in Bipolar Disorder. By treating older subjects having suffered of multiple affective episodes, the potential benefit of psychotherapy to prevent relapse and help to adjust to this chronic illness might be underestimated. In addition, the investigators have no knowledge of mechanism (mediators) of positive changes by successful psychotherapy and of subjects with good outcome of adjuvant psychotherapy (moderators, indicators, predictors). Possible mediators and moderators can be sociodemographic, psychological (cognitive, interactional), and/or biological (neuronal, genetic). The planned study will address all three areas of questions. In a multi-center study, 300 younger subjects suffering of a Bipolar Disorder will be included and provide with one of two treatments in addition to stable medication. Moderators and mediators are selected on promising preliminary results and based on a psycho-biological understanding of Bipolar 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bipolar I and Bipolar II Disorder,
- •18 to 55 years of age,
- •giving informed consent to assessment, treatment, and randomization,
- •currently remitted (for at least 4 weeks) and taking medication,
- •less than 6 previous affective episodes
排除标准
- •currently symptomatic (depressed, manic, hypomanic),
- •suicidal,
- •not taking medication,
- •schizo-affective, schizophrenic, borderline personality disorder,
- •not giving or withdrawing consent
结局指标
主要结局
Time to new affective episode
时间窗: 18 months
At baseline, subjects have to be remitted. Psychotherapies focus on maintenance and relapse prevention. Relapse will be assessed by LIFE interview every six month
次要结局
- Social functioning(18 months)
- Young Mania Rating Scale(18 months)
- Qick-Inventory of Depressive Symptoms(18 months)
- Neurobiological changes (functional, genetic) (functional MRI)(6 months)
研究者
Prof. Dr. Martin Hautzinger
University Professor of Clinical Psychology an Psychotherapy
University Hospital Tuebingen