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临床试验/NCT04130529
NCT04130529已完成不适用

Better Sleep in Psychiatric Care - Bipolar. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Bipolar Disorder

Karolinska Institutet4 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
4
主要终点
Insomnia Severity Index (ISI)

研究概览

简要总结

Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia. Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep. Patients with Bipolar disorder is a patient group with high levels of sleep difficulties. Sleep problems in this patient group can be both more general such as insomnia, but can also be related to the Bipolar disorder. Other research groups have studied the use of behaviorally sleep treatments in patients with Bipolar disorder, but more studies are needed. In a previous pilot study, the investigators of the current study developed a CBT protocol that would target sleep problems in this population. The basis was CBT for insomnia (CBT-i), but with more emphasis on achieving sleep promoting behaviors specific to Bipolar patients, for instance techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light and darkness), and techniques to target more general sleep related problems (e.g. difficulties waking up in the morning), that are also common in patients with Bipolar disorder. This treatment was well tolerated and gave moderate effects on insomnia severity in the pilot study. In a naturalistic randomized controlled trial, the investigators now evaluate the effects of this psychological treatment on sleep and Bipolar symptoms in patients at the departments of Affective disorders, Northern Stockholm Psychiatry and Southwest Psychiatry, Stockholm, Sweden.

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 (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being a patient at the clinics involved in the project
  • Experiencing sleep problems (subjective report)
  • Being able to participate in a psychological intervention in group format

排除标准

  • Night shift work

研究组 & 干预措施

Adjusted group CBT-i for Bipolar disorder

Experimental

The experimental group receives group-CBT-i adjusted for Bipolar disorder. This is a version of CBT for insomnia (CBT-i) developed during the pilot phase of this Project. Traditional CBT-i is adjusted for use in the population with Bipolar Disorder. This behavioral intervention adresses not only traditional aspects of insomnia, but also sleep phase problems and other aspects of sleep specifically relevant to the Bipolar population.

Treatment is given as 8 weekly group sessions.

干预措施: Adjusted group CBT-i for Bipolar disorder (Behavioral)

Sleep lectures

Active Comparator

The control group is offered a series of 3 lectures on sleep during the same time-period.

干预措施: Sleep lectures (Other)

结局指标

主要结局

Insomnia Severity Index (ISI)

时间窗: Changes from base-line to 8 weeks, 5 months and 14 months

7-item, self-rated questionnaire measuring change in insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.

次要结局

  • Affective Self Rating Scale (AS-18)(Changes from base-line to 8 weeks, 5 months and 14 months)
  • Actigraphy(Changes from base-line to post 8 weeks.)
  • WHO Disability Assessment Schedule (WHODAS)(Changes from base-line to 8 weeks, 5 months and 14 months)
  • Daytime Insomnia Symptoms(Changes from base-line to 8 weeks, 5 months and 14 months)
  • Sleep habits and behaviors(Changes from base-line to 8 weeks, 5 months and 14 months)
  • Sleep diary(Two weeks pre-treatment, two weeks post-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susanna Jernelöv

Principal Investigator

Karolinska Institutet

研究点 (4)

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Better Sleep in Psychiatric Care - Bipolar | 临床试验