Evaluating the efficacy and cost-effectiveness of web-based indicated prevention of major depression: design of a randomised controlled trial
- Equal contributors
1 Innovation Incubator, Division Health Training Online, Leuphana University, Lueneburg, Germany
2 Department of Psychology, Clinical Psychology and Psychotherapy, Philipps University Marburg, Marburg, Germany
3 GGZ inGeest, Regional Mental Health Service Centre, VU University Medical Centre, Amsterdam, The Netherlands
4 Department of Clinical Psychology and EMGO Institute for Health and Care Research, VU University, Amsterdam, The Netherlands
5 Department of Public Mental Health, Netherlands Institute of Mental Health and Addiction, Trimbos Institute, Utrecht, The Netherlands
6 Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands
BMC Psychiatry 2014, 14:25 doi:10.1186/1471-244X-14-25Published: 31 January 2014
Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. Web-based interventions have shown to be effective in reducing depressive symptom severity. However, it is not known whether web-based interventions may also be effective in preventing the onset of MDD. The aim of this study is to evaluate the (cost-) effectiveness of an indicated web-based guided self-help intervention (GET.ON Mood Enhancer Prevention) on the onset of MDD.
A randomised controlled trial (RCT) will be conducted to compare the (cost-) effectiveness of the GET.ON Mood Enhancer Prevention training with a control condition exclusively receiving online-based psychoeducation on depression. Adults with subthreshold depression (N = 406) will be recruited from the general population and randomised to one of the two conditions. The primary outcome is time to onset of MDD within a 12-months follow-up period. MDD will be assessed according to DSM-IV criteria as assessed by the telephone-administered Structured Clinical Interview for DSM-IV (SCID). Time to onset of MDD will be assessed using life charts. Secondary outcomes include changes on various indicators of depressive symptom severity, anxiety and quality of life from baseline to post-treatment, to a 6-month and a 12-month follow up. Additionally, an economic evaluation using a societal perspective will be conducted to examine the intervention’s cost-effectiveness.
This is one of the first randomised controlled trials that examines the effect of an indicated guided self-help web-based intervention on the incidence of major depression. If shown to be effective, the intervention will contribute to reducing the disease burden due to MDD in the general population.
German Clinical Trial Registration DRKS00004709.