Insomnia, Insomnia Chronic, Insomnia Disorder, Insomnia Disorders, Insomnia, Nonorganic, Insomnia, Primary, Insomnia Type; Sleep Disorder
Conditions
Keywords
insomnia, cognitive behavioral therapy, bedtime restriction, sleep restriction
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.
Interventions
BEHAVIORALCognitive behavioral therapy for insomnia (CBT-I)
Cognitive Behavioral Therapy for Insomnia (CBT-I) is a gold-standard, evidence-based treatment combining techniques to improve the clinical symptomatology of insomnia. Delivered in six 90-minute group sessions over six weeks, it includes: sleep education (i.e. understanding sleep mechanisms and influencing factors), bedtime restriction (i.e. aligning bedtimes with reported sleep duration), stimulus control (i.e. getting out of bed when unable to sleep), cognitive therapy (i.e. addressing dysfunctional sleep beliefs), relaxation techniques (i.e. using methods like progressive muscle relaxation).
BEHAVIORALBedtime restriction (BRT)
Bedtime Restriction Therapy (BRT): A behavioral intervention aimed at improving the clinical symptomatology of insomnia by aligning time spent in bed with reported sleep duration. Participants attend four 60-minute group therapy sessions over six weeks. The intervention includes: setting individualized sleep windows based on sleep diaries, regular adjustment of sleep schedules to enhance sleep pressure, group discussions to address implementation challenges and maintain motivation. BRT focuses exclusively on bed time restriction without additional cognitive or relaxation components, making it a simplified, resource-efficient approach to treating insomnia.
Sponsors
Christoph Nissen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI) summary scores | Baseline (T0) to 6 weeks (T1), 3 months (T2), and 6 months (T3) |
Countries
Switzerland
Contacts
Primary ContactElisabeth Hertenstein, PD, PhD
Backup ContactMarie Angelillo, MSc
Outcome results
None listed