跳至主要内容
临床试验/NCT03015636
NCT03015636已完成不适用

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

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2016年12月最近更新:
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
58
试验地点
2
主要终点
Insomnia Severity Index

研究概览

简要总结

Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia (CBT-i). 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 ADHD 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 ADHD itself and to the use of ADHD medication. In a previous pilot study, the investigators developed a version of CBT-i that would target sleep problems in this population. The basis was CBT-i, but with more emphasis on sleep promoting behaviors specific to ADHD (e.g. appropriate timing of ADHD-medication), techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light and darkness), and techniques to target more general sleep disturbing habits (e.g. not winding down before bed time), that are also common in patients with ADHD. 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 symptoms of ADHD in patients at the ADHD-clinics, Northern Stockholm Psychiatry, 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 ADHD-clinics Northern Stockholm Psychiatry
  • Experiencing sleep problems (subjective report)

排除标准

  • 未提供

研究组 & 干预措施

Behavioral: Adjusted CBT-i for ADHD

Experimental

Cognitive Behavioral group intervention for sleep problems in ADHD, based on Cognitive Behavioral Therapy for insomnia and behavioral treatment for Sleep Phase Disorders.

干预措施: Adjusted CBT-i for ADHD (Behavioral)

Treatment as Usual

Other

Treatment as Usual. (After about ten weeks, participants in this condition are offered the experimental group treatment.)

干预措施: Treatment as Usual (Other)

结局指标

主要结局

Insomnia Severity Index

时间窗: Changes from base-line to 10 weeks and 3 months

7-item, self-rated questionnaire measuring change in insomnia severity.

次要结局

  • Actigraphy(Continuously from treatment start (week 1) to the last week of treatment (week 10))
  • Sleep diary(Changes from base-line to 10 weeks and 3 months)

研究者

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

Susanna Jernelöv

PhD, LP

Karolinska Institutet

研究点 (2)

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