Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change from baseline in quality of sleep at 8 weeks
研究概览
简要总结
Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases. Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and insomnia.
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
- 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
- •Fulfilling criteria for SCID-1-verified bipolar I or II disorder
- •Euthymic, as defined by Montgomery Åsberg Depression Rating Scale (MADRS) not higher than eleven, and Young Mania Rating scale (YMRS) not higher than five.
- •Fulfilling DSM-IV criteria for primary insomnia or insomnia related to another mental disorder, as assessed by the Insomnia Interview Schedule (IIS).
排除标准
- •Being or having been in a defined affective episode the last month before inclusion
- •Hospitalization in the last two months before inclusion
- •Working night shifts
- •Sleep apnea
- •Medical conditions incompatible with participation.
- •Inability to cooperate in the 3-week initial phase before randomization.
研究组 & 干预措施
CBT-I
Cognitive behavioral therapy for insomnia (CBT-I) is a multicomponent treatment consisting of sleep restriction therapy, psychoeducation about sleep, stimulus control, stabilizing circadian rhythm and challenging beliefs and perception of sleep.
干预措施: Cognitive behavioral therapy for insomnia (Behavioral)
Treatment as usual
Treatment as usual (TAU) consists of pharmacological and supportive psychosocial treatment according to the needs of the patient.
结局指标
主要结局
Change from baseline in quality of sleep at 8 weeks
时间窗: At 8 weeks from randomization
As assessed by the Insomnia Severity Index (ISI)
Change from baseline in quality of sleep at 6 months follow-up
时间窗: 6 months from end of treatment phase
As assessed by the Insomnia Severity Index (ISI)
次要结局
- Variation in sleep registration from baseline to 6 months follow-up(At 6 months)
- Variation in sleep registration from baseline to 8 weeks(At 8 weeks)