Evaluation and implementation of a computer-aided cognitive-behavioural oriented self-help program (moodgym) for general practitioner patients with mild to moderate depressive symptoms – a cluster-randomized study

Not Applicable

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

• Registration Number: DRKS00005075
• Lead Sponsor: Institut für Sozialmedizin, Arbeitsmedizin und Public Health (ISAP), Universität Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-17
• Study Completion: 2015-09-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 647

Inclusion Criteria

internet access and use; German native speaker; clinical diagnosis of mild to moderate first or recurrent depressive disorder according to ICD-10: F32.0, F32.1, F33.0 F33.01; PHQ-9 score between 5 and 14

Exclusion Criteria

Severe depressive episode ICD-10: F32.2, F32.3, F33.2, F33.3, persistent affective disorder F34, bipolar affective disorder F31, schizophrenia and schizoaffective disorders F20-F29, dependence syndrome (except nicotine) F10- F16, F18, F19, dementia und organic mental disorders F00-F09, being in psychotherapeutic treatment, existing suicidality, episode of grief, severe somatic disease (e.g. final stadium of cancer)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in depression symptoms: assessment via questionnaires (BDI-II and PHQ-9) at three<br>assessment points (at GP practice; after 6 weeks, after 6 months)

Secondary Outcome Measures

Name	Time	Method
Assessment via questionnaire: program acceptance, increase in activities, quality of life (EQ-5D) at three assessment points (at GP practice; after 6 weeks, after 6 months);<br><br>Direct healthcare costs from a provider’s perspective, incremental cost-effectiveness-ratio (measure: quality-adjusted life years (QALYs) based on the EQ-5D Index). For health economics evaluation sector-specific individual routine data of the Allgemeine Ortskrankenkasse (AOK) will be provided 36 months after baseline assessment (after written consent of study participants via Wissenschaftliches Institut der Allgemeinen Ortskrankenkasse (WIdO)).