RecruitingNot ApplicableNCT06767137

Comparative Efficacy of BRT and CBT-I for Insomnia

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

Sponsor

Christoph Nissen

Enrollment

160 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria14

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

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Interventions

BEHAVIORALCognitive 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).

BEHAVIORALBedtime 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.