Clinical trial NCT06767137: Comparative Efficacy of BRT and CBT-I for Insomnia
Official title: Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia Disorders
Insomnia Disorder
Insomnia
Insomnia Chronic
Insomnia, Primary
Insomnia, Nonorganic
Insomnia Type; Sleep Disorder
Keywords: insomnia
cognitive behavioral therapy
bedtime restriction
sleep restriction
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Insomnia Severity Index (ISI) summary scores
timeFrame: Baseline (T0) to 6 weeks (T1), 3 months (T2), and 6 months (T3)
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universität Bern, Psychotherapeutische Praxisstelle
city: Geneva
country: Switzerland
facility: Service des specialités psychiatriques, Hôpitaux universitaires de Genève
Study officials:
References: