RecruitingNot Applicable

Comparative Efficacy of BRT and CBT-I for Insomnia

Switzerland160 participantsStarted 2025-03-10

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Insomnia Severity Index (ISI) summary scores

Timeframe: Baseline (T0) to 6 weeks (T1), 3 months (T2), and 6 months (T3)

Trial details

NCT IDNCT06767137

SponsorChristoph Nissen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-01

Contact for this trial

Elisabeth Hertenstein, PD, PhD

+41589440300 sleepwindow@unige.ch