SLEEPwindow
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
Insomnia (difficulty falling asleep and staying asleep)
(BASEC)
diagnostic criteria for insomnia met Age 18-80 years (BASEC)
Criteri di esclusione
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)
Luogo dello studio
Berna, Ginevra
(BASEC)
Sponsor
Prof. Dr. Christoph Nissen Geneva University Hospitals (HUG) Department of Psychiatric Specialties
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Elisabeth Hertenstein
N/A
elisabeth.hertenstein@clutterunige.chDepartment of Psychiatry, Faculty of Medicine, University of Geneva
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ginevra
(BASEC)
Data di approvazione del comitato etico
19.11.2024
(BASEC)
ID di studio ICTRP
NCT06767137 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Comparative efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for insomnia - a randomized controlled non-inferiority trial (BASEC)
Titolo accademico
Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial (ICTRP)
Titolo pubblico
Comparative Efficacy of BRT and CBT-I for Insomnia (ICTRP)
Malattie studiate
Insomnia DisordersInsomnia DisorderInsomniaInsomnia ChronicInsomnia, PrimaryInsomnia, NonorganicInsomnia Type Sleep Disorder (ICTRP)
Intervento studiato
Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)Behavioral: Bedtime restriction (BRT) (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
Insomnia Severity Index (ISI) summary scores (ICTRP)
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Elisabeth Hertenstein, PD, PhD, sleepwindow@unige.ch, +41589440300 (ICTRP)
ID secondari
2024-01324 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06767137 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile