Controlled Study of Chain Blanket for Insomnia

Kontrollerad Studie av Behandling Med kedjetäcken Mot sömnstörning

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Device: Weighted metal chain blanket; Device: Control plastic chain 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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholms Län
    • Stockholm, Stockholms Län, Sweden, SE-14186
      • Psykiatri Sydväst, Huddinge sjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Device: Weighted metal chain blanket; Use of a weighted metal chain blanket of 8 kg
Sham Comparator: 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).	Device: Control plastic chain blanket; A blanket with light plastic chains

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index (ISI)	Self-report rating scale assessing the severity of insomnia symptoms. Range 0-28 with higher scores indicating a more severe insomnia	Change from start to 4 weeks use of the blanket.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Symptom Inventory (FSI)	Self-report symptom rating scale for daytime fatigue symptoms. Range 0-130 with higher scores indicating a more severe fatigue.	Change from start to 4 weeks use of the blanket.
Actigraphy	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	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	Self reported time to sleep onset.	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).	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.	Change from start to 4 weeks use of the blanket.
Insomnia Severity Index (ISI)	Self-report rating scale assessing the severity of insomnia symptoms. Range 0-28 with higher scores indicating a more severe insomnia	Change from start to 8 weeks, 6 and 12 months use of the blanket

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Mats Adler, M.D. Ph.D., Karolinska Institutet

Publications and helpful links

General Publications

• Ekholm B, Spulber S, Adler M. A randomized controlled study of weighted chain blankets for insomnia in psychiatric disorders. J Clin Sleep Med. 2020 Sep 15;16(9):1567-1577. doi: 10.5664/jcsm.8636.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2015
• Primary Completion (Actual): July 7, 2017
• Study Completion (Actual): June 20, 2018

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 15, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2015/102-31/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No