SLEEPwindow
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
Insomnia (difficulty falling asleep and staying asleep)
(BASEC)
diagnostic criteria for insomnia met Age 18-80 years (BASEC)
Ausschlusskriterien
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)
Studienstandort
Bern, Genf
(BASEC)
Sponsor
Prof. Dr. Christoph Nissen Geneva University Hospitals (HUG) Department of Psychiatric Specialties
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Elisabeth Hertenstein
N/A
elisabeth.hertenstein@clutterunige.chDepartment of Psychiatry, Faculty of Medicine, University of Geneva
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Genf
(BASEC)
Datum der Bewilligung durch die Ethikkommission
19.11.2024
(BASEC)
ICTRP Studien-ID
NCT06767137 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Comparative efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for insomnia - a randomized controlled non-inferiority trial (BASEC)
Wissenschaftlicher Titel
Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial (ICTRP)
Öffentlicher Titel
Comparative Efficacy of BRT and CBT-I for Insomnia (ICTRP)
Untersuchte Krankheit(en)
Insomnia DisordersInsomnia DisorderInsomniaInsomnia ChronicInsomnia, PrimaryInsomnia, NonorganicInsomnia Type Sleep Disorder (ICTRP)
Untersuchte Intervention
Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)Behavioral: Bedtime restriction (BRT) (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Insomnia Severity Index (ISI) summary scores (ICTRP)
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Elisabeth Hertenstein, PD, PhD, sleepwindow@unige.ch, +41589440300 (ICTRP)
Sekundäre IDs
2024-01324 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06767137 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar