Group-based Psychoeducation for Relatives of Patients With Bipolar Disorder - a Large Scale Real-world Randomized Controlled Parallel Group Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Change in mood instability in the corresponding patients
研究概览
简要总结
Relatives of patients with bipolar disorder (BD) often experience emotional burden with stress, and depressive symptoms that again increases the likelihood of destabilization and relapses in the patient. The effects of group-based psychoeducation have not been investigated in large-scale real-world settings. The investigators are currently conducting a large-scale real-world randomized controlled parallel group trial (RCT) to test whether group-based psychoeducation for relatives to patients with BD improves mood instability and other critical outcomes in relatives and the corresponding patients with BD.
The trial is designed as a two-arm, parallel group randomized trial with a balanced randomization 1:1 to either group-based psychoeducation or a waiting list for approximately 4 months and subsequent group-based psychoeducation. the investigators plan to include 200 relatives. The group sizes for psychoeducation is between 20-40 relatives.The primary outcome measure is mood instability calculated based on daily smartphone-based mood self-assessment. Other relevant outcomes are measured, including patients' reported outcomes, assessing self-assessed burden, self-efficacy, and knowledge about BD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relatives of patients with Bipolar Disorder who are affiliated with the Copenhagen Affective Disorder Clinic.
排除标准
- •Insufficient Danish language.
- •Age below 18 years.
结局指标
主要结局
Change in mood instability in the corresponding patients
时间窗: daily in 4-8 months.
Mood instability is calculated from daily self-reported mood registration via the app Monsenso. The patients score their daily mood on a scale from -3 to +3, where -3 is the worst and +3 is the best mood. Patients' data from the Monsenso app is collected from a parallel RCT, in the time frame in which the relatives are in the study.
Change in mood instability in the relatives
时间窗: daily in 4-8 months.
Mood instability is calculated from daily self-reported mood registration in the app Monsenso. Participating relatives score their daily mood on a 9-point scale from 0-8 where 8 is 'in a brilliant mood' and 0 is 'really sad' The participant rate daily in the Monsenso app during the time the participate in the study (4-8 months depending on which group they are randomly allocated to). For each participant, a mood instability measure will be estimated for each day and aggregated by applying the root mean square successive difference (rMSSD) method.
次要结局
- Self-rated carer self-efficacy(at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months)
- Clinically observer rated Manic symptoms(at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months)
- Self-reported daily registrations in the Monsenso app on the following topics: daily activity level, sleep, mixed moods, anxiety, irritability, cognition, stress, alchohol consumption, patient support and level of burden from being a caregiver,(daily 4-8 months.)
- Self-rated caregiver burden(at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months)
- Self-rated expressed emotions(at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months)
- Self-rated quality of life(at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months)
- Self-rated Childhood trauma(Only at inclusion)
- Knowledge about bipolar(at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months)
- Self-rated health related quality of life(at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months)
- Self-rated mental health(at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months)
- Self-rated stress(at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months)
- Self-rated bipolar symptoms(at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months)
- Self-rated depressive symptoms(at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months)
- Clinically observer rated Depressive symptoms(At inclusion, at 3-4 months and for the control-group also at 7-8 months.)
- Clinically observer rated General functioning(at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months)
研究者
Lars Vedel Kessing
professor
Mental Health Services in the Capital Region, Denmark