Clinical trial NCT04975776: Sleep Restriction Therapy for Insomnia in Primary Health Care
Official title: Sleep Restriction Therapy for Insomnia Delivered as Group Therapy in Primary Health Care: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2021-07-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in Insomnia Severity Index (ISI) score
timeFrame: Baseline and 3, 6, 12, and 24 months after baseline
Secondary outcomes:
measure: Change in sleep efficiency derived from sleep diary
timeFrame: Baseline and 3, 12, and 24 months after baseline
measure: Change in sleep onset latency derived from sleep diary
timeFrame: Baseline and 3, 12, and 24 months after baseline
measure: Change in time awake after sleep onset derived from sleep diary
timeFrame: Baseline and 3, 12, and 24 months after baseline
measure: Change in number of nocturnal awakenings derived from sleep diary
timeFrame: Baseline and 3, 12, and 24 months after baseline
measure: Change in sleep quality derived from sleep diary
timeFrame: Baseline and 3, 12, and 24 months after baseline
measure: Change in Fatigue Severity Scale (FSS) score
timeFrame: Baseline and 3, 12, and 24 months after baseline
measure: Change in the Montgomery-Asberg Depression Rating Scale - self-rating version (MADRS-S) score
timeFrame: Baseline and 3, 12, and 24 months after baseline
measure: Changes in the EQ-5D score
timeFrame: Baseline and 3, 12, and 24 months after baseline
measure: Changes in the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) score
timeFrame: Baseline and 3, 12, and 24 months after baseline
measure: Changes in Work Ability Index (WAI) score
timeFrame: Baseline, 1 year after baseline, and 2 years after baseline
measure: Changes in Short Form Health Survey-12 (SF- 12) score
timeFrame: Baseline and 3, 12, and 24 months after baseline
measure: Change in Work and Social Adjustment Scale (WSAS) scores
timeFrame: Baseline and 3, 12, and 24 months after baseline
measure: Changes in self-reported hypnotic drug use
timeFrame: Baseline and 3, 12, and 24 months after baseline
measure: Changes in self-reported sick leave
timeFrame: Baseline, 1 year after baseline, and 2 years after baseline
measure: Treatment side effects
timeFrame: 3 months after baseline
measure: Treatment adherence
timeFrame: 3 months after baseline
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Christina Sandlund
state: Stockholms Läns Landsting
Study officials:
affiliation: Region Stockholm
name: Christina Sandlund, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.