Nurse-led sleep restriction therapy for insomnia in primary care
Sleep Restriction Therapy for Insomnia Delivered as Group Therapy in Primary Health Care: A Randomized Controlled Trial
This study tests if a short, nurse-led group program that helps people with insomnia by limiting their sleep can work better and be more affordable than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm, Stockholms Läns Landsting) |
| Trial ID | NCT04975776 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a brief, nurse-led group intervention based on sleep restriction therapy for treating insomnia in primary care settings. The study aims to determine if this approach can reduce insomnia severity and is cost-effective compared to standard care. Health care professionals will be trained to deliver the intervention, and patients meeting specific criteria will be randomized to receive either the therapy or written sleep hygiene information. The trial will also evaluate barriers and facilitators to participation and delivery of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults who meet the DSM-5 criteria for insomnia disorder and experience significant distress or impairment due to their sleep difficulties.
Not a fit: Patients with severe psychiatric illnesses or those whose insomnia is primarily caused by other sleep-wake disorders or substance effects may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a more accessible and effective treatment option for patients suffering from insomnia.
How similar studies have performed: Previous studies have shown that behavioral interventions like sleep restriction therapy can be effective for insomnia, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm, Stockholms Läns Landsting
- Christina Sandlund — Stockholm, Stockholms Läns Landsting, Sweden (Recruiting)
Study contacts
- Principal investigator: Christina Sandlund, PhD — Region Stockholm
- Study coordinator: Christina Bini, MSc
- Email: christina.bini@regionstockholm.se
- Phone: 46738732627
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.