Menu
Recruiting NCT06767137

Comparative Efficacy of BRT and CBT-I for Insomnia

No phase Interventional Insomnia Disorders Insomnia Disorder Insomnia Insomnia Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive behavioral therapy for insomnia (CBT-I), Bedtime restriction (BRT).
Who it may be relevant to
Registry conditions: Insomnia Disorders, Insomnia Disorder, Insomnia, Insomnia Chronic. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Cognitive behavioral therapy for insomnia (CBT-I)
    Cognitive Behavioral Therapy for Insomnia (CBT-I) is a gold-standard, evidence-based treatment combining techniques to improve the clinical symptomatology of insomnia. Delivered in six 90-minute group sessions over six weeks, it includes: sleep education (i.e. understanding sleep mechanisms and influencing factors), bedtime restriction (i.e. aligning bedtimes with reported sleep duration), stimulus control (i.e. getting out of bed when unable to sleep), cognitive therapy (i.e. addressing dysfunc
  • Behavioral Bedtime restriction (BRT)
    Bedtime Restriction Therapy (BRT): A behavioral intervention aimed at improving the clinical symptomatology of insomnia by aligning time spent in bed with reported sleep duration. Participants attend four 60-minute group therapy sessions over six weeks. The intervention includes: setting individualized sleep windows based on sleep diaries, regular adjustment of sleep schedules to enhance sleep pressure, group discussions to address implementation challenges and maintain motivation. BRT focuses

Primary outcome measures

  • Insomnia Severity Index (ISI) summary scores [Time frame: Baseline (T0) to 6 weeks (T1), 3 months (T2), and 6 months (T3)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Switzerland · 2 centers
  • Universität Bern, Psychotherapeutische Praxisstelle — Bern
  • Service des specialités psychiatriques, Hôpitaux universitaires de Genève — Geneva

Identifiers

NCT: NCT06767137 · 2024-01324

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗