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Completed

NCT Number: NCT03546036

Controlled Study of Chain Blanket for Insomnia

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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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psykiatri Sydväst, Huddinge sjukhus

Stockholm, Stockholm County, SE-14186, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weighted metal chain blanket

Device

Use of a weighted metal chain blanket of 8 kg

Control plastic chain blanket

Device

A blanket with light plastic chains

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Kontrollerad Studie av Behandling Med kedjetäcken Mot sömnstörning

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 6, 2018
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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