Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial
| Registry | NCT06767137, acronym SLEEPwindow |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 160 (Estimated) |
| Sponsor | Christoph Nissen (Other) |
| Conditions | Insomnia Disorders, Insomnia Disorder, Insomnia, Insomnia Chronic, Insomnia, Primary, Insomnia, Nonorganic, Insomnia Type; Sleep Disorder |
| Interventions | Cognitive behavioral therapy for insomnia (CBT-I), Bedtime restriction (BRT) (Behavioral) |
| Dates | start 2025-03-10 (estimated), primary completion 2027-11-01 (estimated), completion 2027-11-01 (estimated), first posted 2025-01-09, last updated 2025-02-17 |
| Locations | 2 sites in Switzerland |
Related Papers Related Patents Related Grants Related Experts
All trials for Insomnia Disorders All trials for Insomnia Disorder All trials of Cognitive behavioral therapy for insomnia (CBT-I) All trials of Bedtime restriction (BRT)
This study evaluates two behavioral treatments for patients with insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). Both therapies aim to improve the clinical symptomatology of insomnia by teaching participants techniques to better manage their sleep schedule and habits. BRT is a simpler and shorter therapy focused on aligning the time spent in bed with reported sleep time. CBT-I includes additional components such as relaxation techniques and cognitive exercises. The study will compare these treatments to see if BRT is as effective as CBT-I in improving the clinical symptomatology of insomnia.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cognitive behavioral therapy for insomnia (CBT-I) | Experimental | Behavioral: Cognitive behavioral therapy for insomnia (CBT-I) | |
| Bedtime restriction (BRT) | Experimental | Behavioral: Bedtime restriction (BRT) |
Sex: All, ages: 18 Years to 80 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Universität Bern, Psychotherapeutische Praxisstelle | Bern, Canton of Bern | Switzerland | Recruiting |
| Service des specialités psychiatriques, Hôpitaux universitaires de Genève | Geneva, Canton of Geneva | Switzerland | Recruiting |