Sleep Restriction Therapy for Insomnia Delivered as Group Therapy in Primary Health Care: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Region Stockholm
- Enrollment
- 104
- Locations
- 2
- Primary Endpoint
- Change in Insomnia Severity Index (ISI) score
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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
Outcomes
Primary Outcomes
Change in Insomnia Severity Index (ISI) score
Time Frame: 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.
Secondary Outcomes
- Change in sleep efficiency 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 onset latency derived from sleep diary(Baseline and 3, 12, and 24 months after baseline)
- Change in Fatigue Severity Scale (FSS) score(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)
- Changes in Work Ability Index (WAI) score(Baseline, 1 year after baseline, and 2 years after baseline)
- Changes in self-reported sick leave(Baseline, 1 year after baseline, and 2 years after baseline)
- Change in time awake after sleep onset derived from sleep diary(Baseline and 3, 12, and 24 months after baseline)
- Changes in the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) score(Baseline and 3, 12, and 24 months after baseline)
- Change in Work and Social Adjustment Scale (WSAS) scores(Baseline and 3, 12, and 24 months after baseline)
- Changes in self-reported hypnotic drug use(Baseline and 3, 12, and 24 months after baseline)
- Change in the Montgomery-Asberg Depression Rating Scale - self-rating version (MADRS-S) score(Baseline and 3, 12, and 24 months after baseline)
- Changes in Short Form Health Survey-12 (SF- 12) score(Baseline and 3, 12, and 24 months after baseline)
- Changes in the EQ-5D score(Baseline and 3, 12, and 24 months after baseline)
- Treatment side effects(3 months after baseline)
- Treatment adherence(3 months after baseline)