Insomnia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEWeighted metal chain blanket
Use of a weighted metal chain blanket of 8 kg
DEVICEControl plastic chain blanket
A blanket with light plastic chains
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomization to intervention or control parallell groups on a 50/50 basis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Symptom Inventory (FSI) | Change from start to 4 weeks use of the blanket. | Self-report symptom rating scale for daytime fatigue symptoms. Range 0-130 with higher scores indicating a more severe fatigue. |
| Actigraphy | Change from start to 4 weeks use of the blanket. . | An actigraph attached to the arm of the participants on the week before the intervention and during the fourth (last) week of the intervention assessing sleep by interpretation of movement |
| 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. | Self reported time to sleep onset. |
| Hospital Anxiety and Depression Scale (HAD). | Change from start to 4 weeks use of the blanket. | HAD is a self report rating scale for anxiety and depression symptoms.The HAD is subdivided into subscales for depressive symptoms (HAD-D) and anxiety symptoms (HAD-A), with a range of 0-21 for each subscale. Higher scores indicates more severe symptoms. |
| Insomnia Severity Index (ISI) | Change from start to 8 weeks, 6 and 12 months 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 |
Countries
Sweden
Outcome results
None listed