NCT06767137

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Christoph Nissen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).
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.

Timeline

• Start date: 2025-03-10
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2025-01-09
• Last updated: 2025-02-17

Locations

2 sites across 1 country: Switzerland