Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Switzerland / NCT06767137
Recruiting Not applicable

Comparative Efficacy of BRT and CBT-I for Insomnia

NCT06767137 · tracked via the Priya Life Science Switzerland tracker
Sponsor
Christoph Nissen
Phase
Not applicable
Started
2025-03-10
Last updated
2025-02-17

Condition(s) studied

Insomnia DisordersInsomnia DisorderInsomniaInsomnia ChronicInsomnia, PrimaryInsomnia, NonorganicInsomnia Type; Sleep Disorder

Investigational drug(s) / intervention(s)

Cognitive behavioral therapy for insomnia (CBT-I)Bedtime restriction (BRT)

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).

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Universität Bern, Psychotherapeutische Praxisstelle Bern Canton of Bern Recruiting
Service des specialités psychiatriques, Hôpitaux universitaires de Genève Geneva Canton of Geneva Recruiting

Other trials for the same condition

The COMET Study: a Prospective COhort of MEdical residenTs to Assess Professional, Personal and Psychological Trajectories of Residents in General Internal Medicine Recruiting
No More Sleepless Nights in Perimenopause Recruiting
Mental Imagery and Targeted Memory Reactivation in Insomnia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06767137 on ClinicalTrials.gov ↗ ← All trials in Switzerland