Sleep Restriction Therapy for Insomnia in Primary Health Care

NCT ID: NCT04975776

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2027-08-30

Brief 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

Keywords

Disorders of Initiating and Maintaining Sleep; DIMS; Early Awakening; Awakening, Early; Nonorganic Insomnia; Insomnia, Nonorganic; Primary Insomnia; Insomnia, Primary; Transient Insomnia; Insomnia, Transient; Rebound Insomnia; Insomnia, Rebound; Secondary Insomnia; Insomnia, Secondary; Sleep Initiation Dysfunction; Dysfunction, Sleep Initiation; Dysfunctions, Sleep Initiation; Sleep Initiation Dysfunctions; Sleeplessness; Insomnia Disorder; Insomnia; Insomnias; Chronic Insomnia; Insomnia, Chronic; Psychophysiological Insomnia; Insomnia, Psychophysiological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sleep restriction therapy

Four group sessions delivered at the participants' primary health care centers once a week for 3 weeks and again after a 4-week pause. The first session will last for 2 hours and the other sessions for 1 hour.

Group Type: EXPERIMENTAL

Sleep restriction therapy

Intervention Type: BEHAVIORAL

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

Participants in the active comparator group will receive a brochure with sleep hygiene advice from the primary health care center at baseline.

Group Type: ACTIVE_COMPARATOR

Sleep hygiene

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Sandlund, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Stockholm

Locations

Christina Sandlund

Stockholm, Stockholms Läns Landsting, Sweden

Countries

Sweden

References

Maurer LF, Schneider J, Miller CB, Espie CA, Kyle SD. The clinical effects of sleep restriction therapy for insomnia: A meta-analysis of randomised controlled trials. Sleep Med Rev. 2021 Aug;58:101493. doi: 10.1016/j.smrv.2021.101493. Epub 2021 Apr 21.

Reference Type: BACKGROUND

PMID: 33984745 (View on PubMed)

Kyle SD, Morgan K, Spiegelhalder K, Espie CA. No pain, no gain: an exploratory within-subjects mixed-methods evaluation of the patient experience of sleep restriction therapy (SRT) for insomnia. Sleep Med. 2011 Sep;12(8):735-47. doi: 10.1016/j.sleep.2011.03.016. Epub 2011 Sep 9.

Reference Type: BACKGROUND

PMID: 21907616 (View on PubMed)

Sandlund C, Hetta J, Nilsson GH, Ekstedt M, Westman J. Improving insomnia in primary care patients: A randomized controlled trial of nurse-led group treatment. Int J Nurs Stud. 2017 Jul;72:30-41. doi: 10.1016/j.ijnurstu.2017.03.007. Epub 2017 Apr 14.

Reference Type: BACKGROUND

PMID: 28445790 (View on PubMed)

Sandlund C, Kane K, Ekstedt M, Westman J. Patients' experiences of motivation, change, and challenges in group treatment for insomnia in primary care: a focus group study. BMC Fam Pract. 2018 Jul 9;19(1):111. doi: 10.1186/s12875-018-0798-2.

Reference Type: BACKGROUND

PMID: 29986651 (View on PubMed)

Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.

Reference Type: BACKGROUND

PMID: 28875581 (View on PubMed)

Related Links

https://www.akademisktprimarvardscentrum.se/om-oss/projektkatalog/forskning-for-att-effektivare-bedoma-och-behandla-somnproblem-i-primarvarden/

Academic Primary Health Care Centre, Region Stockholm

Other Identifiers

FoUI-936149

Identifier Type: -

Identifier Source: org_study_id