SLEEPwindow
Summary description of the study
Insomnia is a sleep disorder characterized by difficulties in falling asleep and staying asleep, as well as reduced well-being and performance during the day. Insomnia can be very effectively treated with Cognitive Behavioral Therapy (CBT-I). However, CBT-I is not yet well implemented in everyday care. Many affected individuals do not receive appropriate treatment. This project will investigate a behavioral short-term program aimed at making it more widely available.
(BASEC)
Intervention under investigation
It has already been demonstrated in numerous scientific studies that CBT-I is very effective. A central therapeutic component of this therapy is sleep time restriction. This involves reducing the average time spent in bed by having patients go to bed later or get up earlier than before. The goal is to increase sleep pressure and thus improve falling asleep and staying asleep – similar to a wave that builds up gradually. This research project will now investigate whether a short-term treatment focused on sleep time restriction is as effective as the complete CBT-I. The latter additionally includes therapeutic elements such as relaxation exercises and changing difficult thoughts. We will examine a total of 160 individuals with insomnia in Bern and Geneva. Participants will be randomly assigned to either classic CBT-I or the new short-term program. We want to find out whether the new short-term program improves sleep quality and daytime well-being as effectively as classic CBT-I.
(BASEC)
Disease under investigation
Insomnia (difficulty falling asleep and staying asleep)
(BASEC)
diagnostic criteria for insomnia met Age 18-80 years (BASEC)
Exclusion criteria
unstable, progressive, or degenerative medical (including psychiatric) condition indications of organic sleep disorders such as Restless Legs Syndrome or Sleep Apnea Syndrome substance abuse or dependence regular use of certain sleep medications currently in psychotherapy for sleep problems (BASEC)
Trial sites
Bern, Geneva
(BASEC)
Sponsor
Prof. Dr. Christoph Nissen Geneva University Hospitals (HUG) Department of Psychiatric Specialties
(BASEC)
Contact
Contact Person Switzerland
Elisabeth Hertenstein
N/A
elisabeth.hertenstein@clutterunige.chDepartment of Psychiatry, Faculty of Medicine, University of Geneva
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Geneva
(BASEC)
Date of authorisation
19.11.2024
(BASEC)
ICTRP Trial ID
NCT06767137 (ICTRP)
Official title (approved by ethics committee)
Comparative efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for insomnia - a randomized controlled non-inferiority trial (BASEC)
Academic title
Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial (ICTRP)
Public title
Comparative Efficacy of BRT and CBT-I for Insomnia (ICTRP)
Disease under investigation
Insomnia DisordersInsomnia DisorderInsomniaInsomnia ChronicInsomnia, PrimaryInsomnia, NonorganicInsomnia Type Sleep Disorder (ICTRP)
Intervention under investigation
Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)Behavioral: Bedtime restriction (BRT) (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Inclusion/Exclusion 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 (ICTRP)
not available
Primary and secondary end points
Insomnia Severity Index (ISI) summary scores (ICTRP)
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Elisabeth Hertenstein, PD, PhD, sleepwindow@unige.ch, +41589440300 (ICTRP)
Secondary trial IDs
2024-01324 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06767137 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available