Comparing two therapies for insomnia treatment
Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial
This study is testing whether a new sleep therapy called Bedtime Restriction Therapy works just as well as the more common Cognitive Behavioral Therapy for Insomnia to help adults with insomnia sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Geneva, Switzerland Academic / other |
| Locations | 2 sites (Bern, Canton of Bern and 1 other locations) |
| Trial ID | NCT06767137 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two behavioral treatments for insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). BRT focuses on aligning the time spent in bed with actual sleep time, while CBT-I includes additional techniques such as relaxation and cognitive exercises. The goal is to determine if BRT is as effective as CBT-I in alleviating insomnia symptoms. Participants will be adults aged 18 to 80 who meet specific criteria for insomnia disorder.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who meet DSM-5 criteria for insomnia disorder and can provide informed consent.
Not a fit: Patients with unstable medical conditions, severe psychiatric disorders, or other sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with effective treatment options for managing insomnia.
How similar studies have performed: Previous studies have shown positive outcomes for both BRT and CBT-I, indicating that this comparative approach is grounded in established therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must meet DSM-5 criteria for insomnia disorder. * Adults aged 18 to 80 years * Capable of giving written informed consent. * Sufficient fluency in the study site's language (i.e., German or French) to understand all study-related information. Exclusion Criteria: * Unstable, progressive, or degenerative medical condition * Acute pain or poorly managed chronic pain * Suicidality * Uncontrolled psychiatric condition requiring treatment outside of study * Alcohol or drug abuse or dependency * Diagnosis of psychosis, bipolar disorder, autism, borderline personality disorder, or antisocial personality disorder * Clinical evidence of sleep disorders other than insomnia (e.g., sleep apnea, restless legs, periodic limb movements in sleep, parasomnia) * Evidence of intellectual disability * Regular intake of benzodiazepines (BZD) or benzodiazepine receptor agonists (BZDRA) * Alteration of medication within 4 weeks prior to study treatment or planned alteration during the trial period (stable medication except BZD or BZDRA does not lead to exclusion) * Current other psychotherapy for insomnia * Known pregnancy or breastfeeding * Inability to comply with study procedure * Insufficient fluency in German or French to complete the study
Where this trial is running
Bern, Canton of Bern and 1 other locations
- Universität Bern, Psychotherapeutische Praxisstelle — Bern, Canton of Bern, Switzerland (Recruiting)
- Service des specialités psychiatriques, Hôpitaux universitaires de Genève — Geneva, Canton of Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Elisabeth Hertenstein, PD, PhD
- Email: sleepwindow@unige.ch
- Phone: +41589440300
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.