Comparative Efficacy of BRT and CBT-I for Insomnia

NCT06767137 | Recruiting

• 1 other identifier: 2024-01324
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Insomnia Disorders; Insomnia Disorder; Insomnia; Insomnia Chronic; Insomnia, Primary; Insomnia, Nonorganic; Insomnia Type; Sleep Disorder

Keywords

insomnia; cognitive behavioral therapy; bedtime restriction; sleep restriction

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI) summary scores

  Baseline (T0) to 6 weeks (T1), 3 months (T2), and 6 months (T3)

Study Arms (2)

Cognitive behavioral therapy for insomnia (CBT-I)

EXPERIMENTAL

Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)

Bedtime restriction (BRT)

EXPERIMENTAL

Behavioral: Bedtime restriction (BRT)

Interventions

Cognitive behavioral therapy for insomnia (CBT-I) BEHAVIORAL

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).

Cognitive behavioral therapy for insomnia (CBT-I)

Bedtime restriction (BRT) BEHAVIORAL

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.

Bedtime restriction (BRT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Christoph Nissen: lead

Study Sites (2)

Universität Bern, Psychotherapeutische Praxisstelle

Bern, Canton of Bern, 3012, Switzerland

RECRUITING

Service des specialités psychiatriques, Hôpitaux universitaires de Genève

Geneva, Canton of Geneva, 1201, Switzerland

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Elisabeth Hertenstein, PD, PhD

CONTACT

+41589440300; sleepwindow@unige.ch

Marie Angelillo, MSc

CONTACT

+4158 944 03 00; sleepwindow@unige.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 9, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)