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

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 - @ktiv trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005075

Enrollment

632

Registered

2013-07-17

Start date

2014-02-06

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression F32.0 F32.1 F33.0 F33.1

Interventions

Group 1: Treatment as usual in primary care (TAU) plus MoodGym, an internetbased cognitive-behavioural oriented self-help program. MoodGYM comprises five interactive modules ("Feelings", "Thoughts", "

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
change in depression symptoms: assessment via questionnaires (BDI-II and PHQ-9) at three assessment points (at GP practice; after 6 weeks, after 6 months)	—

Secondary

Measure	Time frame
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); 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)).	—

Measure

Time frame

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); 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)).

—

Countries

Germany

Contacts

Public ContactMargrit Löbner

Institut für Sozialmedizin, Arbeitsmedizin und Public Health, Universität Leipzig

margrit.loebner@medizin.uni-leipzig.de0341 - 97 24591

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 18, 2026