App against Depression - Efficacy of a guided smartphone self-management app for mild to moderate depression.

Not Applicable

• Conditions: F34.1; F32.0; F32.1; F33.0; F33.1; F32.9; F33.9; Dysthymia; Mild depressive episode; Moderate depressive episode

• Registration Number: DRKS00031388
• Lead Sponsor: Stiftung Deutsche Depressionshilfe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

Mild to moderate depressive episode in the context of a unipolar depressive episode (ICD-10 F32.0; F32.1, F32.9) or a recurrent unipolar depressive disorder (ICD-10: F33.0, F33.1, F33.9) or a dysthymia
- Outpatient status
- Respondent is able to communicate both verbally and in writing, German-speaking
- Internet-enabled smartphone to download and use the intervention (iFightDepression app)
- 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 last 6 months based on information from the treating physician/therapist. Acute suicidality (according to item 9 PHQ and physician). Physical illness requiring immediate (partial) inpatient 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 current study is the improvement of depressive symptoms through participation in an internet-based self-management app in adults with mild to moderate depression compared to a TAU control group (treatment as usual). 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.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary outcome are changes in quality of life (SF-12) and improvement of depressive symptoms (IDS-SR) compared to the TAU control group 3 months after the end of the intervention. An exploratory analysis of patient satisfaction (ZUF-8/CSQ-8) as well as the usage of outpatient care services will be conducted and both results will be compared to those found in the literature. <br>The frequency of logins, number of entries and completed workshops (as objective measures) as well as the amount of guidance (according to self-report) will be reported descriptively.