Insomnia F51.0
Conditions
Interventions
Group 1: Intervention Group (innov. dCBT-I) - receives an 8-week CBT-I-based app program including a subjective sleep diary and objective continuous sleep measurement (using a heart rate sensor) with
Sponsors
Paris Lodron Universität Salzburg - Labor für Schlaf, Kognition und Bewusstseinsstörung
ÖAW - Österreichische Akademie der Wissenschaften
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: Insomnia
Exclusion criteria
Exclusion criteria: BMI 35, severe physical (e.g. tumour disease) or psychiatric diagnosis (e.g. schizophrenia, post-traumatic stress disorder, major depression, severe anxiety disorder), other sleep disorders, ISI <10, current substance abuse or withdrawal, use of prescription sleep medication, previous completion of cognitive behavioural therapy for insomnia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective sleep quality: - Questionnaires (Pittsburgh Sleep Quality Index (PSQI); Insomnia Severity Index (ISI), each at T0, T1, T2, T3) - Sleep diary data (change in sleep parameters (e.g., SOL, NOA, WASO) between T0/T1 and T2) Objective sleep quality: - Ambulatory polysomnography (change in sleep parameters (e.g., SOL, NOA, WASO) at T0, T1, T2) - Based on heart rate sensor (change in sleep parameters (e.g., SOL, NOA, WASO) between T0/T1 and T2) Number of responders: - based on the Insomnia Severity Index (number of individuals with a change in ISI score of at least 8 points between T0/T1 and T2/T3 (1 month)) Remission rate: - based on the Insomnia Severity Index (number of individuals with an ISI score of 7 or less at T2 or T3 (1 month)) Discrepancy between subjective and objective sleep quality: - based on sleep diary and heart rate sleep measurement: change in the difference between subjective and objective sleep parameters (e.g., SOL, NOA, WASO) between T0/T1 and T2 T0: Start of the study (baseline) T1: Start of the 8-week intervention phase T2: End of the 8-week intervention phase T3: Follow-up 1 and 6 months after T2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive abilities (declarative memory): - Word Pair Association Test with interference (WPT): T0, T1, T2 Well-being (mental health and quality of life): - Questionnaires (Brief Symptom Inventory (BSI); WHO Quality of Life (short version) (WHOQOL-Bref), each at T0, T1, T2, T3 T0: Start of the study (baseline) T1: Start of the 8-week intervention phase T2: End of the 8-week intervention phase T3: Follow-up 1 and 6 months after T2 | — |
Countries
Austria
Contacts
Public ContactAlexandra Hinterberger
Paris Lodron Universität Salzburg - Labor für Schlaf, Kognition und Bewusstseinsforschung
Outcome results
None listed