NCT04975776

Sleep Restriction Therapy for Insomnia in Primary Health Care

Sleep Restriction Therapy for Insomnia Delivered as Group Therapy in Primary Health Care: A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Region Stockholm · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. A process evaluation will explore barriers and facilitators for participation and delivery. 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. Patient characteristics will be analyzed in relation to adherence, and response. Qualitative explorations of patients and nurses' experiences will be conducted alongside the trial (approximately 15 patients and 15 nurses).

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2022-02-01
• Primary completion: 2027-08-30
• Completion: 2027-08-30
• First posted: 2021-07-23
• Last updated: 2025-12-23

Locations

1 site across 1 country: Sweden