Comparative Efficacy of BRT and CBT-I for Insomnia

Not Applicable

Recruiting

• Conditions: Insomnia Disorders; Insomnia Disorder; Insomnia; Insomnia Chronic; Insomnia, Primary; Insomnia, Nonorganic; Insomnia Type; Sleep Disorder

• Registration Number: NCT06767137
• Lead Sponsor: Christoph Nissen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Study Start: 2025-03-10
• Primary Completion: 2027-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI) summary scores	Baseline (T0) to 6 weeks (T1), 3 months (T2), and 6 months (T3)

Trial Locations

Locations (2)

Universität Bern, Psychotherapeutische Praxisstelle; 🇨🇭 Bern, Switzerland

Service des specialités psychiatriques, Hôpitaux universitaires de Genève; 🇨🇭 Geneva, Switzerland