Sleep Restriction Therapy for Insomnia in Primary Health Care

  • STATUS
    Recruiting
  • End date
    Dec 13, 2025
  • participants needed
    200
  • sponsor
    Region Stockholm
Updated on 13 May 2022
behavior therapy
poor sleep
cognitive behavioral therapy for insomnia
sleep restriction therapy

Summary

The recommended treatment for insomnia, cognitive behavioral therapy for insomnia (CBT-I), is effective. However, its long, multi-component nature makes it challenging to implement in ordinary primary care, where most people are treated. An important component of CBT-I is sleep restriction therapy, which may be comparatively easy to carry out in routine primary care. This project tests whether a brief nurse-led group intervention in primary care based on sleep restriction therapy for insomnia reduces insomnia severity and is cost-effective.

Description

Background: Insomnia is typically treated in primary health care. The most common treatment is hypnotic drugs, despite their limited and short-term effects, the risk for adverse side effects and dependence, and the fact that CBT-I is the recommended first-line treatment. Reasons may include lack of knowledge about insomnia, a culture of prescribing hypnotics, lack of time during consultations, and a shortage of CBT-I providers. Sleep restriction therapy is one of the core components of CBT-I. It is a behavioral technique that may be feasible to deliver in routine care with existing resources and time constraints.

Objectives: This randomized controlled trial aims to investigate whether brief, behavioral group therapy in primary care based on sleep restriction therapy reduces insomnia severity and is cost-effective.

Methods: Health care professionals from participating primary health care centers will complete a 1.5-day digital course on assessing patients for insomnia and delivering the intervention. Patients who seek primary health care and meet the study criteria will be randomized to sleep restriction therapy or to receive written sleep hygiene information. Both groups will be free to seek and receive standard care for insomnia. Sociodemographic and clinical characteristics will be collected prior to baseline. Study outcomes include insomnia severity, sleep, daytime symptoms, quality of life, use of hypnotics, sick leave, and work ability. Outcomes will be assessed over a 24-month period. The cost-effectiveness analysis will include the number of insomnia-free days at the 12-month follow-up and quality-adjusted life years.

Details
Condition Insomnia
Treatment Sleep Restriction Therapy, Sleep Hygiene
Clinical Study IdentifierNCT04975776
SponsorRegion Stockholm
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Fulfills the DSM-5 diagnostic criteria for insomnia disorder: a) Difficulty initiating sleep, difficulty maintaining sleep, and early morning awakenings despite adequate opportunity for sleep (e.g., adequate time and circumstances for sleep and a safe, quiet, and dark bedroom). b) The sleep difficulties cause significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. c) The sleep difficulties occur at least 3 nights per week and have been present for at least 3 months. d) The symptoms are not better explained by and do not occur exclusively during the course of another sleep-wake disorder. e) The symptoms cannot be attributed to the effects of a substance (e.g., drug abuse and medication). f) Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia

Exclusion Criteria

Severe psychiatric illness (e.g., severe depression, schizophrenia, bipolar disorder)
Suicidal ideation
Untreated sleep disorder other than insomnia (e.g., sleep apnea, and restless legs syndrome)
Epilepsy
Cognitive disorder
Pregnancy
Night shift work
Language difficulties (inability to understand and speak Swedish well enough to participate in the intervention and respond to measurement instruments)
≤ 7 points on the Insomnia Severity Index
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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