Comparative Efficacy of BRT and CBT-I for Insomnia

NCT ID: NCT06767137

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2027-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive behavioral therapy for insomnia (CBT-I)

Group Type: EXPERIMENTAL

Cognitive behavioral therapy for insomnia (CBT-I)

Intervention Type: 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).

Bedtime restriction (BRT)

Group Type: EXPERIMENTAL

Bedtime restriction (BRT)

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Christoph Nissen

OTHER

Sponsor Role: lead

Responsible Party

Christoph Nissen

Prof. Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Universität Bern, Psychotherapeutische Praxisstelle

Bern, Canton of Bern, Switzerland

Site Status: RECRUITING

Service des specialités psychiatriques, Hôpitaux universitaires de Genève

Geneva, Canton of Geneva, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Elisabeth Hertenstein, PD, PhD

Role: CONTACT

sleepwindow@unige.ch

+41589440300

Marie Angelillo, MSc

Role: CONTACT

sleepwindow@unige.ch

+4158 944 03 00

Facility Contacts

Thomas Berger, Prof. Dr.

Role: primary

sleepwindow@unige.ch

+4158 944 03 00

Elisabeth Hertenstein, PD, PhD

Role: primary

sleepwindow@unige.ch

+4158 944 03 00

Other Identifiers

2024-01324

Identifier Type: -

Identifier Source: org_study_id