Controlled Study of Chain Blanket for Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-04

Study Completion Date

2018-06-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization to intervention or control parallell groups on a 50/50 basis.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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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)

Group Type EXPERIMENTAL

Weighted metal chain blanket

Intervention Type DEVICE

Use of a weighted metal chain blanket of 8 kg

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).

Group Type SHAM_COMPARATOR

Control plastic chain blanket

Intervention Type DEVICE

A blanket with light plastic chains

Interventions

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Weighted metal chain blanket

Use of a weighted metal chain blanket of 8 kg

Intervention Type DEVICE

Control plastic chain blanket

A blanket with light plastic chains

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No