Actively Recruiting
Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial
Led by Christoph Nissen · Updated on 2025-02-17
160
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two behavioral treatments for adults with insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). The study aims to compare these therapies to determine if the simpler BRT is as effective as CBT-I in improving insomnia symptoms. Both treatments teach techniques to better manage sleep schedules and habits to help improve sleep quality. CBT-I involves six 90-minute group sessions over six weeks and includes sleep education, bedtime restriction, stimulus control, cognitive therapy, and relaxation techniques. BRT is a shorter, simpler therapy with four 60-minute group sessions over six weeks, focusing only on aligning time in bed with actual sleep duration through individualized sleep windows and group discussions to support participants. Participants will attend therapy sessions and complete assessments at the start and at 6 weeks, 3 months, and 6 months to monitor changes in insomnia severity using the Insomnia Severity Index (ISI). The study also monitors participant adherence and overall clinical symptom improvement during these periods. Total participation spans at least six months with regular evaluations to assess outcomes and treatment effects.
CONDITIONS
Brief Title
Comparative Efficacy of BRT and CBT-I for Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 (German or French) to understand all study-related information
You will not qualify if you...
- 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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 weeks
Participants receive behavioral therapy aimed at improving insomnia symptoms. CBT-I involves six 90-minute group sessions over six weeks including sleep education, bedtime restriction, stimulus control, cognitive therapy, and relaxation techniques. BRT involves four 60-minute group sessions over six weeks focusing on bedtime restriction.
4 to 6 group sessions depending on assigned therapy
Trial Site Locations
Total: 2 locations
1
Universität Bern, Psychotherapeutische Praxisstelle
Bern, Canton of Bern, Switzerland, 3012
Actively Recruiting
2
Service des specialités psychiatriques, Hôpitaux universitaires de Genève
Geneva, Canton of Geneva, Switzerland, 1201
Actively Recruiting
Research Team
E
Elisabeth Hertenstein, PD, PhD
M
Marie Angelillo, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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