Kontrollerad Studie av Behandling Med kedjetäcken Mot sömnstörning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The aim of the study is to compare an intervention with a weighted metal chain blanket of 8 kg with a control plastic chain blanket of 1,5 kg for patients with Major depressive disorder, bipolar disorder, Generalized Anxiety Disorder (GAD) and/or attention deficit hyperactivity disorder (ADHD) and co-occurring insomnia. Patients are evaluated by a rater blind to treatment allocation with Insomnia Severity Index (ISI), Fatigue Symptom Inventory (FSI), Hospital Anxiety and Depression Scale (HAD) and actigraphy before, during and at primary end-point after 4 weeks use of the blanket.
详细描述
Insomnia is a common and problematic symptom in many psychiatric disorders. The aim of this study is to evaluate the effect of weighted chain blankets on insomnia and other sleep-related symptoms for patients with Major depressive disorder, Bipolar disorder, Generalized Anxiety Disorder (GAD) and/or ADHD. Potential participants are asked to participate in a study comparing two different types of chain blankets, not mentioning the difference in weight. After signing a informed consent, participants were randomly assigned on a 50/50 basis to a weighted blanket containing metal chains weighing 8 kg or a control blanket containing plastic chains weighing 1,5 kg. Insomnia severity is assessed before and weekly until endpoint at four weeks use of the blanket by a rater blind to treatment allocation. Participants sleep will also be monitored by actigraphy. The controlled phase of the study is followed by a one year open follow up study where all participants are offered to use a weighted blanket of any type.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Study participants were kept blind to treatment allocation by the information that they would be assigned to one of two types of chain blanket, without any information of the difference in weight. The outcome assessor and investigator did not participate in randomization and treatment and were blind to treatment allocation.
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
- •Clinical insomnia for more than two months with a score over 14 points at the Insomnia Severity Index (ISI)1 and a diagnosis of either major depressive disorder, bipolar disorder, Generalized Anxiety disorder (GAD) or ADHD.
排除标准
- •active drug abuse,
- •overuse of sleep medication,
- •illness affecting cognitive functions, such as dementia, schizophrenia, developmental disorders, Parkinson's disease or an acquired brain injury.
研究组 & 干预措施
Weighted metal chain blanket
As experimental intervention, a weighted metal chain blanket of 8 kg was used during the night. Using a flexible dose protocol, participants who found the 8 kg blanket too heavy were allowed to change to a 6 kg weighted blanket (see below)
干预措施: Weighted metal chain blanket (Device)
Control plastic chain blanket
As sham comparator, light chain blankets were used, were plastic chains of the same shape and size as the metal chains in the weighted blanket were sewn in. The control blanket has a weight of 1535 grams. When checking the weight of standard blankets for sale in one of the largest stores in Stockholm, weight was ranging from 550 to 2389 grams (average 1332).
干预措施: Control plastic chain blanket (Device)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Change from start to 4 weeks use of the blanket.
Self-report rating scale assessing the severity of insomnia symptoms. Range 0-28 with higher scores indicating a more severe insomnia
次要结局
- Fatigue Symptom Inventory (FSI)(Change from start to 4 weeks use of the blanket.)
- Insomnia Severity Index (ISI)(Change from start to 8 weeks, 6 and 12 months use of the blanket)
- Actigraphy(Change from start to 4 weeks use of the blanket. .)
- "Day and night diaries", developed by Assistive technology Stockholm for the evaluation of weighted blankets(Change from start to 4 weeks use of the blanket in patient estimated time (minutes) from going to bed to sleep onset.)
- Hospital Anxiety and Depression Scale (HAD).(Change from start to 4 weeks use of the blanket.)
研究者
Mats Adler
Principal investigator
Karolinska Institutet