Insomnia, Climacteric symptoms
Conditions
Brief summary
The primary outcome variable is the difference between the groups in the within-subject change in insomnia severity at T1 (2 months) and T2 (4 months) relative to T0 (baseline). Insomnia severity will be assessed with the Insomnia Severity Index (ISI) (Bastien et al., 2001) at these three timepoints.
Detailed description
Other sleep outcomes: subjective sleep efficiency (sleep diary), objective sleep efficiency, REM sleep fragmentation (EEG headband)., Depressive symptoms: IDS-SR, Other mental health outcomes: RMT-20, PMH scale, MHQoL, EuroQoL, Wellbeing and daytime functioning: PLB, Cantrill's ladder, Climacteric symptoms: GCS, HFRDIS, objective frequency hotflushes (watch), Individual differences: Sleep history (questionnaire), CTQ, PSST, EPDS
Interventions
Sponsors
Amsterdam UMC Stichting
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable is the difference between the groups in the within-subject change in insomnia severity at T1 (2 months) and T2 (4 months) relative to T0 (baseline). Insomnia severity will be assessed with the Insomnia Severity Index (ISI) (Bastien et al., 2001) at these three timepoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other sleep outcomes: subjective sleep efficiency (sleep diary), objective sleep efficiency, REM sleep fragmentation (EEG headband)., Depressive symptoms: IDS-SR, Other mental health outcomes: RMT-20, PMH scale, MHQoL, EuroQoL, Wellbeing and daytime functioning: PLB, Cantrill's ladder, Climacteric symptoms: GCS, HFRDIS, objective frequency hotflushes (watch), Individual differences: Sleep history (questionnaire), CTQ, PSST, EPDS | — |
Countries
Netherlands
Outcome results
None listed