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
- 1
- 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
研究组 & 干预措施
FEST Clinical Supportive Educational
This supportive, active control psychotherapy (FEST) is using general principals and non-specific interventions such as positive attitude, optimism, support, empathy, focus on emotion, self-help, strengthening and eliciting own resources, time and room for discussion of personal experiences. Psychoeducation about illness and drug treatment (mood stabilizer) to facilitate compliance.
干预措施: FEST - Clinical Supportive Educational (Behavioral)
SEKT Cognitive-Behavioral-Emotional
Specific psychotherapy (SEKT - 4 modules) for typical problems of Bipolar patients to maintain remission and to prevent relapse. Including classical elements of self observation, psychoeducation, cognitive and behavioral interventions, social rhythm but also emotion regulation and meta-cognitive techniques. Delivered in a group setting in 4 one day treatment workshops, each one month apart. Homework assignment and electronical monitoring during time between sessions.
干预措施: SEKT - Cognitive-Behavioral-Emotional (Behavioral)
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
- Neurobiological changes (functional, genetic) (functional MRI)(6 months)
- Social functioning(18 months)
- Young Mania Rating Scale(18 months)
- Qick-Inventory of Depressive Symptoms(18 months)
研究者
Prof. Dr. Martin Hautzinger
University Professor of Clinical Psychology an Psychotherapy
University Hospital Tuebingen