App against Depression - Pilot study - Usability and acceptance of a self-management smartphone app for mild to moderate depression.

Phase 1

• Conditions: F32.0; F32.1; F33.0; F33.1; F34.1; F32.9; F33.9; Mild depressive episode; Moderate depressive episode; Recurrent depressive disorder, current episode mild

• Registration Number: DRKS00025603
• Lead Sponsor: Stiftung Deutsche Depressionshilfe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-07
• Study Completion: 2023-01-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 56

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br>Measurement time points: <br><br>Before start of intervention (T0: IDS, SF-12). <br> <br>4 weeks after start of intervention (T1: IDS, SF-12, documentation AE/SAE), <br> <br>End of intervention (T2: IDS, ZUF-8, SF-12, NEQ, documentation AE/SAE) <br>