Sleep Restriction Therapy for Insomnia in Primary Health Care

NCT04975776 | Active Not Recruiting

• 1 other identifier: FoUI-936149
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index (ISI) score

  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.

  Baseline and 3, 6, 12, and 24 months after baseline

Secondary Outcomes (16)

• Change in sleep efficiency derived from sleep diary

  Baseline and 3, 12, and 24 months after baseline

• Change in sleep onset latency derived from sleep diary

  Baseline and 3, 12, and 24 months after baseline

• Change in time awake after sleep onset derived from sleep diary

  Baseline and 3, 12, and 24 months after baseline

• Change in number of nocturnal awakenings derived from sleep diary

  Baseline and 3, 12, and 24 months after baseline

• Change in sleep quality derived from sleep diary

  Baseline and 3, 12, and 24 months after baseline

Study Arms (2)

Sleep restriction therapy

EXPERIMENTAL

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.

Behavioral: Sleep restriction therapy

Sleep hygiene

ACTIVE COMPARATOR

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

Behavioral: Sleep hygiene

Interventions

Sleep restriction therapy 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 restriction therapy

Sleep hygiene 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.

Sleep hygiene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Christina Sandlund

Stockholm, Stockholms Läns Landsting, 104 31, Sweden

Location

Related Publications (5)

• 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.

  PMID: 33984745 BACKGROUND

• 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.

  PMID: 21907616 BACKGROUND

• 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.

  PMID: 28445790 BACKGROUND

• 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.

  PMID: 29986651 BACKGROUND

• 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.

  PMID: 28875581 BACKGROUND

Related Links

• Academic Primary Health Care Centre, Region Stockholm

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Christina Sandlund, PhD

  Region Stockholm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Study staff entering data will be blinded to the condition. The researchers will provide some supervision to the health care professional who deliver the treatment. The researchers will therefore know the identities of the health care professionals they supervise. However, outcome data will be pseudonymized, so researchers will be blinded during outcome assessment. It is not possible to blind the health care professionals delivering the treatment or patients receiving it.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A multi-center randomized controlled trial in primary health care with two parallel study arms: (1) sleep restriction group therapy (experimental condition) and (2) sleep hygiene (control condition).

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 23, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)