F32.0 F33.0 F32.1 F33.1 F32.2 F33.2 F32.8 F33.8 F32.9 F33.9
Conditions
Interventions
Group 1: Group 1 receives access to somnio (mementor DE GmbH), a digital health application that delivers cognitive-behavioral psychotherapy for insomnia (24 weeks).
Group 2: Group 2 waits for 24 week
Sponsors
Heinrich-Heine-Universität Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Current depression (diagnostic interview & Beck Depression Inventory [BDI] > 8). - Self-reported sleep difficulties (diagnostic interview & ISI > 10) - Confident use of the smartphone/tablet/computer - Stable Internet access
Exclusion criteria
Exclusion criteria: - Bipolar disorder - Epilepsy - Pregnancy - Presence of another sleep disorder (diagnostic interview) - Regular drug and alcohol use (> 3 glasses of alcohol per day, more than 21 days), marijuana use (> 1x per week; self-report) - Acute suicidality (suicide item > 1 in the Beck Depression Inventory BDI & suicidality according to questioning in a telephone interview) - Psychosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression severity, post-treatment (12 weeks post-randomization) as measured with the Patient Health Questionnaire (PHQ-9). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Insomnia severity (ISI; 12 & 24 weeks post-randomization) - Daytime sleepiness (ESS; 12 & 24 weeks post-randomization) - Fatigue (FSS; 12 & 24 weeks post-randomization) - Quality of life (WHQOL_BREF; 12 & 24 weeks post-randomization) - Emotional state (PANAS; 12 & 24 weeks post-randomization) - Sleep continuity (sleep diary; 12 weeks post-randomization) - Self-efficacy (PCS; 12 & 24 weeks post-randomization) - Emotion regulation (RSQ; 12 & 24 weeks post-randomization) | — |
Countries
Germany
Contacts
Public ContactAnnika Gieselmann
Heinrich-Heine-Universität Düsseldorf
Outcome results
None listed