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

Not Applicable

• Conditions: F32.0; F32.1; F33.0; F33.1; F34.1; Mild depressive episode; Moderate depressive episode; Recurrent depressive disorder, current episode mild; Recurrent depressive disorder, current episode moderate; Dysthymia

• Registration Number: DRKS00009323
• Lead Sponsor: Stiftung Deutsche Depressionshilfe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-25
• Study Completion: 2019-09-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 347

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>

Secondary Outcome Measures

Name	Time	Method
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.<br>Measurement: <br>before the beginning of the intervention (T0: IDS, PHQ-9, CGI, SF-12)<br><br>weekly during the intervention (PHQ-9, rating of the workshops)<br><br>3 weeks after the beginning of the intervention (T1: IDS, CGI, documentation AE/SAE),<br><br>at the end of intervention (T2: IDS, PHQ-9, CGI, ZUF-8, SF-12, documentation of AE/SAE),<br><br>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)