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Controlled Study of Chain Blanket for Insomnia

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ClinicalTrials.gov Identifier: NCT03546036
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
Region Stockholm
Information provided by (Responsible Party):
Mats Adler, Karolinska Institutet

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insomnia Device: Weighted metal chain blanket Device: Control plastic chain blanket Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization to intervention or control parallell groups on a 50/50 basis.
Masking: Triple (Participant, 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.
Primary Purpose: Treatment
Official Title: Kontrollerad Studie av Behandling Med kedjetäcken Mot sömnstörning
Actual Study Start Date : March 4, 2015
Actual Primary Completion Date : July 7, 2017
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Insomnia Severity Index (ISI) [ Time Frame: 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 Outcome Measures :
  1. Fatigue Symptom Inventory (FSI) [ Time Frame: 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.

  2. Actigraphy [ Time Frame: 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

  3. "Day and night diaries", developed by Assistive technology Stockholm for the evaluation of weighted blankets [ Time Frame: 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.

  4. Hospital Anxiety and Depression Scale (HAD). [ Time Frame: 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.

  5. Insomnia Severity Index (ISI) [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546036


Locations
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Sweden
Psykiatri Sydväst, Huddinge sjukhus
Stockholm, Stockholms Län, Sweden, SE-14186
Sponsors and Collaborators
Karolinska Institutet
Region Stockholm
Investigators
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Principal Investigator: Mats Adler, M.D. Ph.D. Karolinska Institutet
  Study Documents (Full-Text)

Documents provided by Mats Adler, Karolinska Institutet:
Study Protocol  [PDF] November 1, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mats Adler, Principal investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03546036    
Other Study ID Numbers: 2015/102-31/2
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders