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Efficacy of an internet-based self-management intervention for adult primary care patients with mild and moderate depression or dysthymia

Efficacy of an internet-based self-management intervention for adult primary care patients with mild and moderate depression or dysthymia - Get.Started!

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00009323
Enrollment
250
Registered
2016-02-25
Start date
2016-05-01
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

F32.0 F32.1 F33.0 F33.1 F34.1

Interventions

Group 1: 6 weeks of CBT based self-management training with the online Tool "IfightDepression". Each week the participant will work on one of the following topics: "thinking, feeling and doing", "slee

Sponsors

Stiftung Deutsche Depressionshilfe
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Mild or moderate depression, dysthymia or recurrent depression according to MINI (ICD-10: F32.0; F32.1; F33.0; F33.1; F34.1), 18-75 years of age, outpatient status, sufficient language skills (regarding both speaking and writing) and able to meet the requirements of the study, Internet-access (privately at home or sufficient opportunity to access the internet regularly), written informed consent

Exclusion criteria

Exclusion criteria: ICD-10 diagnoses: dementia, alcohol/ drug addiction; schizophrenia; manic episode or bipolar disorder; obsessive-compulsive disorder according to MINI (F0, F1, F2, F30, F31, F42), acute suicidal tendencies, known personality disorder (F60.2, F60.31), Severe somatic disorders requiring immediate treatment, Participation in another clinical trial within the last 4 weeks, known alcohol/ drug abuse within the last 6 months, pregnancy

Design outcomes

Primary

MeasureTime frame
Primary outcome of the study is the reduction of depressive symptoms in the treatment group compared to the control condition as measured by the IDS-SR-score after the 6 week Intervention.

Secondary

MeasureTime frame
Secondary outcomes are changes in depressive sympotms over the course of the intervention (PHQ-9, IDS, CGI), the acceptance and feasibility (ZUF-8) of the "ifightDepressoin" tool and other training effects such as changes in perceived quality of life (SF-12). We also plan to look at possible adverse effects (INEP) and moderating variables e.g. gender. Measurement: before the beginning of the intervention (T0: IDS, PHQ-9, CGI, SF-12) weekly during the intervention (PHQ-9, rating of the workshops) 3 weeks after the beginning of the intervention (T1: IDS, CGI, documentation AE/SAE), at the end of intervention (T2: IDS, PHQ-9, CGI, ZUF-8, SF-12, documentation of AE/SAE), follow up 3, 6 and 12 Month after the end of the intervention (T3,4 and5: IDS, CGI, ZUF-8, SF-12, documentation of AE/SAE, PHQ-9)

Countries

Germany

Contacts

Public ContactCaroline Oehler

Stiftung Deutsche DepressionshilfeForschungszentrum Depression

caroline.oehler@medizin.uni-leipzig.de0341/97-24597

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 3, 2026