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Intervention and evaluation study within the framework of the project "Internet-based, moderated self-management program depression"

Intervention and evaluation study within the framework of the project "Internet-based, moderated self-management program depression"

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00005492
Enrollment
700
Registered
2014-02-21
Start date
2014-03-01
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

F32.1 F32.0

Interventions

Group 1: Intervention group: Receives access to the program, implementation of the program over 10 weeks. Data collection takes place within the period of intervention by the repeated filling out onl

Sponsors

Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Leipzig AöR
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • patients with initial diagnosis of unipolar depression, currently mild to moderate episode (ICD-10 F32.0 F32.1-) or patients who were only once unable to work due to depression for no more than 42 days within the last 3 years, and that were not located in any inpatient or outpatient treatment, • Age = 18 years, • Access to a computer with Internet access and possession of an own email address and / or mobile phone.

Exclusion criteria

Exclusion criteria: • Age <18 years • existence of substance addiction disorder of (alcohol, drugs) • presence of major depression (ICD-10 F32.2 F32.3-) or recurrent depressive episode (ICD-10 F33. -) • suicidality • other mental disorders such as schizophrenia or bipolar affective disorder

Design outcomes

Primary

MeasureTime frame
scientific question: 1 a) Are there changes in the intervention group by the use of the program in terms of disease symptoms and disease-specific quality of life? Executes the program to a reduction in disease symptoms and increase in disease-specific quality of life? 1 b ) To what extent will the online program be accepted by the patient and fully processed ? How satisfied are the patients with the program? 2 How do the intervention group differ (gains access to the internet-based , moderated self-management program ) from the control group in terms of disability and hospital days? Ad 1. The changes in the level of depressive symptoms of the participants are compiled by the use of the Patient Health Questionnaire (PHQ-9) at multiple time points (as a baseline prior to the start of the self-management program as well as during the entire 10-week duration of the self-management program and directly determined after completion of the self-management program, at least 4 weeks after completion). For this, the Patient Health Questionnaire will be a integral part of the self-management program. This will provide the opportunity for users to assess their own progress. The quality of life is measured by means of the EuroQol questionnaire at multiple time points (as a baseline prior to the start of the self-management program and directly determined after completion of the self-management program, at least 4 weeks after completion), which is also an integral part of the program. Ad 2. There, the number of re-admissions, inpatient bed days and days off work will be provided for both the intervention group and the control group that is denied access to the program by the collaborating health insurance after the 10 weeks.

Secondary

MeasureTime frame
1 For users of the self-management program, a satisfaction questionnaire is (adapted from ZUF-8) as well as questions on the acceptance that specifically refers to the self-management program are integrated into the program. 2 The use of the program will continue to be collected through data to dropout (premature termination of the program) and adherence (For information how patients have used the materials, such as defined by Logon - Logout, number of processed modules and exercises)

Countries

Germany

Contacts

Public ContactChristine Rummel-Kluge

Zentrum für Klinische Studien (ZKS)Universität LeipzigKlinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Leipzig AöR

Christine.Rummel-Kluge@medizin.uni-leipzig.de0341 9724530

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026