Better Sleep in Psychiatric Care - ADHD. (BSIP-ADHD)
2019年10月21日 更新者：Susanna Jernelöv、Karolinska Institutet
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.
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.
研究概览
研究类型
介入性
注册 (实际的)
58
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Stockholm、瑞典、113 21
- Department of ADHD, Northern Stockholm Psychiatry
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Being a patient at the ADHD-clinics Northern Stockholm Psychiatry
- Experiencing sleep problems (subjective report)
Exclusion Criteria:
- None
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Behavioral: Adjusted CBT-i for ADHD
Cognitive Behavioral group intervention for sleep problems in ADHD, based on Cognitive Behavioral Therapy for insomnia and behavioral treatment for Sleep Phase Disorders.
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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 adult ADHD population.
This behavioral intervention adresses not only traditional aspects of insomnia, but also sleep phase problems and other aspects of sleep specifically relevant to the ADHD-population.
Treatment is given as 10 weekly group sessions with telephone calls from the therapist between sessions to increase adherence and adress individual patient needs.
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其他：Treatment as Usual
Treatment as Usual.
(After about ten weeks, participants in this condition are offered the experimental group treatment.)
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Usual care at the ADHD-clinic.
This mostly entails managing pharmacological treatment for ADHD, comorbid psychiatric problems and/or sleep problems.
The clinic also provides different group treatments, for instance mindfulness groups and groups for developing behavioral strategies for managing ADHD symptoms, and individual therapy.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Insomnia Severity Index
大体时间：Changes from base-line to 10 weeks and 3 months
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7-item, self-rated questionnaire measuring change in insomnia severity.
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Changes from base-line to 10 weeks and 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Actigraphy
大体时间：Continuously from treatment start (week 1) to the last week of treatment (week 10)
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An actigraph is placed on the participant's arm for one week.
It measures participants' activity in the form of movements.
It can be used for acquiring data on sleep and daytime activity, including calculated sleep latency, total sleep time, sleep efficiency, wake after sleep onset, variability in sleep timing and daytime activity.
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Continuously from treatment start (week 1) to the last week of treatment (week 10)
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Sleep diary
大体时间：Changes from base-line to 10 weeks and 3 months
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Daily self-ratings on a number of sleep parameters, resulting in several measures including sleep latency, wake after sleep onset, total sleep time, sleep efficiency, subjective sleep quality and variability in sleep timing
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Changes from base-line to 10 weeks and 3 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Brunnsviken brief quality of life scale
大体时间：Changes from base-line to 10 weeks and 3 months
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12-items self-rating questionnaire measuring quality of life.
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Changes from base-line to 10 weeks and 3 months
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Adult ADHD Self-Report Scale
大体时间：Changes from base-line to 10 weeks and 3 months
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18-items self-report questionnaire measuring ADHD-symptoms.
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Changes from base-line to 10 weeks and 3 months
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Dysfunctional Beliefs and Attitudes about Sleep
大体时间：Changes from base-line to 10 weeks and 3 months
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10-items self-rating questionnaire measuring sleep related cognitions.
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Changes from base-line to 10 weeks and 3 months
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Sleep Problems Acceptance Questionnaire
大体时间：Changes from base-line to 10 weeks and 3 months
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8-items self-rating questionnaire measuring acceptance of sleep problems.
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Changes from base-line to 10 weeks and 3 months
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Sleep habits and behaviors
大体时间：Changes from base-line to 10 weeks and 3 months
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Self-rating questionnaire regarding the use of sleep promoting behaviors.
The questionnaire was constructed for the current project and consists of two parts.
The first part includes 16 statements such as "Last week I got out of bed within 15 minutes of waking up" to be answered by number of days the last week this was true (i.e. from 0 to 7).
The other part is to be answered on a 6-point Likert scale from "Not at all true" to "Entirely true", with 7 statements like "I get out of bed the same time every morning".
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Changes from base-line to 10 weeks and 3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Susanna Jernelöv, PhD, LP、Karolinska Institutet
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Adler LA, Spencer T, Faraone SV, Kessler RC, Howes MJ, Biederman J, Secnik K. Validity of pilot Adult ADHD Self- Report Scale (ASRS) to Rate Adult ADHD symptoms. Ann Clin Psychiatry. 2006 Jul-Sep;18(3):145-8. doi: 10.1080/10401230600801077.
- Lindner P, Frykheden O, Forsstrom D, Andersson E, Ljotsson B, Hedman E, Andersson G, Carlbring P. The Brunnsviken Brief Quality of Life Scale (BBQ): Development and Psychometric Evaluation. Cogn Behav Ther. 2016 Apr;45(3):182-95. doi: 10.1080/16506073.2016.1143526. Epub 2016 Feb 17.
- Espie CA, Inglis SJ, Harvey L, Tessier S. Insomniacs' attributions. psychometric properties of the Dysfunctional Beliefs and Attitudes about Sleep Scale and the Sleep Disturbance Questionnaire. J Psychosom Res. 2000 Feb;48(2):141-8. doi: 10.1016/s0022-3999(99)00090-2.
- Bothelius K, Jernelov S, Fredrikson M, McCracken LM, Kaldo V. Measuring Acceptance of Sleep Difficulties: The Development of the Sleep Problem Acceptance Questionnaire. Sleep. 2015 Nov 1;38(11):1815-22. doi: 10.5665/sleep.5170.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年12月1日
初级完成 (实际的)
2018年11月21日
研究完成 (实际的)
2018年11月21日
研究注册日期
首次提交
2017年1月6日
首先提交符合 QC 标准的
2017年1月9日
首次发布 (估计)
2017年1月10日
研究记录更新
最后更新发布 (实际的)
2019年10月23日
上次提交的符合 QC 标准的更新
2019年10月21日
最后验证
2019年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
多动症的临床试验
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University Hospital, Strasbourg, France招聘中
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Centre for Anxiety, Attention Deficit and Trauma...Shire完全的
Adjusted CBT-i for ADHD的临床试验
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VA Office of Research and DevelopmentVA Finger Lakes Healthcare System招聘中
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Indiana UniversityIndiana Clinical and Translational Sciences Institute终止