Sleep Restriction Therapy for Insomnia in Primary Health Care

NCT04975776 · tracked via the Priya Life Science Sweden tracker

Sponsor

Region Stockholm

Phase

Not applicable

Started

2022-02-01

Last updated

2025-12-23

Condition(s) studied

Insomnia

Investigational drug(s) / intervention(s)

Sleep restriction therapySleep hygiene

Sleep restriction therapy: The intervention includes psychoeducation and sleep restriction therapy, sleep restriction instructions, problem-solving, and support for participants in adjusting sleep restriction instructions to their individual needs and life circumstances. At the final session, participants create an individual plan for maintaining new sleep habits and coping with insomnia relapse. During the intervention, participants are free to seek and receive standard care for insomnia.

Sleep hygiene: The control condition will include written, general information about sleep and lifestyle and environmental factors that could improve or disturb sleep. The participants will be free to seek and receive standard care for insomnia.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Change in Insomnia Severity Index (ISI) score — Baseline and 3, 6, 12, and 24 months after baseline
The ISI is a 7-item scale that asesses the severity of sleep disturbance, how much sleep disturbance interferes with daily life and functioning, the noticeability of these impairments to others, worry and distress resulting from sleep disturbance, and general sleep satisfaction/dissatisfaction. Responses are provided on a Likert-scale (0-4). The total score ranges from 0 to 28, and higher scores indicate more severe problems.

Trial sites (1)

Facility	City	Region	Status
Christina Sandlund	Stockholm	Stockholms Läns Landsting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04975776 on ClinicalTrials.gov ↗ ← All trials in Sweden