F32.0 F32.1 F33.0 F33.1 F34.1 F32.9 F33.9
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Mild to moderate depressive episode in the context of a unipolar depressive episode (ICD-10 F32.0; F32.1) or recurrent unipolar depressive disorder (ICD-10: F33.0, F33.1) or dysthymia -Ambulatory state -Proband is able to communicate both orally and in writing, German-speaking -Internet-enabled smartphone to download the app and use the intervention. -Written informed consent -PHQ-9 score 5-19
Exclusion criteria
Exclusion criteria: ICD-10 diagnoses: dementia, alcohol dependence, drug dependence, schizophrenia, mania and bipolar disorder, obsessive-compulsive disorder (F0, F1, F2, F30, F31, F42), personality disorder (F60.2, F60.31), Known alcohol or drug abuse within the past 6 months based on information provided by attending physician/therapist Acute suicidality (according to item 9 PHQ and physician). Physical illness requiring immediate (partial) stationary treatment Participation in another clinical trial within the last 4 weeks Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the planned study is to evaluate the improvement of depressive symptoms through participation in an internet-based self-management app "iFD" in adults with mild to moderate depression. Evidence of improvement will be provided by a pre-post comparison. The primary outcome measure is the German version of the "Inventory of Depressive Symptomatology - Self Report" (IDS-SR) after the end of the 8-week intervention, which is conducted as a self-rating. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are acceptance and satisfaction (ZUF-8), impact on quality of life (SF-12), assessment of potential side effects (NEQ), and gender differences in the named parameters. Measurement time points: Before start of intervention (T0: IDS, SF-12). 4 weeks after start of intervention (T1: IDS, SF-12, documentation AE/SAE), End of intervention (T2: IDS, ZUF-8, SF-12, NEQ, documentation AE/SAE) | — |
Countries
Germany
Contacts
Stiftung Deutsche Depressionshilfe Forschungszentrum