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NCT Number: NCT06767137

Comparative Efficacy of BRT and CBT-I for Insomnia

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.

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Key information

Conditions

Insomnia Disorders Dyssomnias Insomnia Insomnia Chronic Insomnia Disorder Insomnia Type; Sleep Disorder Insomnia, Nonorganic Insomnia, Primary Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universität Bern, Psychotherapeutische Praxisstelle, Bern, Canton of Bern, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

Insomnia Severity Index (ISI) summary scores

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

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabeth Hertenstein, PD, PhD

CONTACT

[email protected]

+41589440300

Marie Angelillo, MSc

CONTACT

[email protected]

+4158 944 03 00

Sponsors and collaborators

Lead sponsor

Christoph Nissen

Other

Registry information

Official study title

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

Acronym: SLEEPwindow

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Jan 9, 2025
Registry last updated: Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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