Clinical trial Recruiting at 2 sites Interventional Ages 18 to 80

Comparing two therapies for insomnia treatment

Official title: Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial

Run by University of Geneva, Switzerland · NCT06767137 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment160 (estimated)
SponsorUniversity of Geneva, Switzerland
Academic / other
Locations2 sites (Bern, Canton of Bern and 1 other locations)
StatusRecruiting
StartedMarch 10, 2025
Main results expectedNovember 1, 2027
Study endsNovember 1, 2027
Registry record updatedFebruary 17, 2025
Trial IDNCT06767137 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 80 who meet DSM-5 criteria for insomnia disorder and can provide informed consent.

Probably not a fit

Patients with unstable medical conditions, severe psychiatric disorders, or other sleep disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Potential benefit: If successful, this study could provide patients with effective treatment options for managing insomnia.

How similar studies have gone: Previous studies have shown positive outcomes for both BRT and CBT-I, indicating that this comparative approach is grounded in established therapies.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.