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临床试验/NCT03852966
NCT03852966已完成不适用

Better Sleep in Psychiatric Care - ADHD. A Pragmatic Within-group Pilot Study to Develop and Evaluate Effects and Feasibility of a CBT-based Manual for Treating Sleep Problems in Adult Patients With ADHD

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2015年9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
19
试验地点
1
主要终点
Insomnia Severity Index (ISI)

研究概览

简要总结

Comorbidities, including sleep problems, are common in adult Attention Deficit Hyperactivity Disorder (ADHD). Treatment of choice for insomnia is cognitive behavioral therapy (CBT-i), but evidence is lacking for CBT-i in patients with ADHD and sleep problems.

The purpose of this study was to investigate if patients at a specialist clinic for ADHD benefit from a group delivered CBT-i treatment; whether insomnia severity improves following this treatment.

This pragmatic within-group pilot study with a pre to post and three-month follow-up design was set at a specialist psychiatric out-patient clinic for adult ADHD.

As an adjunct to care-as-usual at the clinic, a CBT-i-based group treatment targeting sleep problems prevalent in the ADHD-population, designed for patients with executive difficulties, was offered as 10 weekly 90-minute group sessions and scheduled telephone support.

All outcome measures were subjectively reported by participants. Data analyzed with dependent t-tests according to intent-to-treat.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • •being a patient at the clinic (i.e. having a diagnosis of AD(H)D)
  • •self-reported sleep problems
  • •returning pre-treatment questionnaires and signed consent form

排除标准

  • 未提供

研究组 & 干预措施

CBT-i/ADHD

Experimental

Behavioral treatment for sleep problems in ADHD

干预措施: CBT-i/ADHD (Behavioral)

结局指标

主要结局

Insomnia Severity Index (ISI)

时间窗: Change from baseline to 24 weeks

7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)

Insomnia Severity Index (ISI)

时间窗: Change from baseline to 10 weeks

7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)

次要结局

  • Adult ADHD Self-Report Scale (ASRS)(Change from baseline to 24 weeks)
  • Adult ADHD Self-Report Scale (ASRS)(Change from baseline to 10 weeks)

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 (1)

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