Comparative Efficacy of BRT and CBT-I for Insomnia (SLEEPwindow)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Insomnia Chronic; Insomnia Disorder; Insomnia, Primary; Insomnia Type; Sleep Disorder; Insomnia Disorders; Insomnia, Nonorganic
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy for insomnia (CBT-I); Behavioral: Bedtime restriction (BRT)

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth Hertenstein, PD, PhD; Phone Number: +41589440300; Email: sleepwindow@unige.ch
• Study Contact Backup: Name: Marie Angelillo, MSc; Phone Number: +4158 944 03 00; Email: sleepwindow@unige.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3012
    • Recruiting
    • Universität Bern, Psychotherapeutische Praxisstelle
    • Contact: Thomas Berger, Prof. Dr.; Phone Number: +4158 944 03 00; Email: sleepwindow@unige.ch
  • Geneva, Switzerland, 1201
    • Recruiting
    • Service des specialités psychiatriques, Hôpitaux universitaires de Genève
    • Contact: Elisabeth Hertenstein, PD, PhD; Phone Number: +4158 944 03 00; Email: sleepwindow@unige.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive behavioral therapy for insomnia (CBT-I)	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 dysfunctional sleep beliefs), relaxation techniques (i.e. using methods like progressive muscle relaxation).
Experimental: Bedtime restriction (BRT)	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 exclusively on bed time restriction without additional cognitive or relaxation components, making it a simplified, resource-efficient approach to treating insomnia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Insomnia Severity Index (ISI) summary scores	Baseline (T0) to 6 weeks (T1), 3 months (T2), and 6 months (T3)

Collaborators and Investigators

• Sponsor: Christoph Nissen

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: insomnia; cognitive behavioral therapy; sleep restriction; bedtime restriction
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
• Other Study ID Numbers: 2024-01324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No