Comparative Efficacy of BRT and CBT-I for Insomnia

Launched by CHRISTOPH NISSEN · Jan 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different types of behavioral treatments for people who struggle with insomnia, which is a sleep disorder that makes it hard to fall asleep or stay asleep. The two treatments being compared are Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). BRT is a shorter and simpler method that helps people spend the right amount of time in bed based on how much sleep they actually get. On the other hand, CBT-I is a more comprehensive approach that includes various techniques, such as relaxation exercises and changing unhelpful thoughts about sleep. The goal is to see if BRT is just as effective as CBT-I in helping people with their insomnia symptoms.

To participate in this study, you need to be an adult between 18 and 80 years old and meet certain criteria for insomnia. You should also be able to understand the study information in German or French. However, some people may not be eligible, such as those with serious medical conditions, certain psychiatric disorders, or ongoing treatments that could interfere with the trial. If you join, you can expect to learn helpful strategies to improve your sleep and participate in a supportive environment aimed at helping you feel better.

Gender

ALL

Eligibility criteria

• 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