The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention

Klein JP, Berger T, Schroeder J, et al. The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention. BMC Psychiatry. 2013;13(1): 239.Background: Depressive disorders are among the leading causes of worldwide disability with mild to moderate forms of depression being particularly common. Low-intensity treatments such as online psychological treatments may be an effective way to treat mild to moderate depressive symptoms and prevent the emergence or relapse of major depression. Methods/Design: This study is a currently recruiting multicentre parallel-groups pragmatic randomized-controlled single-blind trial. A total of 1000 participants with mild to moderate symptoms of depression from various settings including in-and outpatient services will be randomized to an online psychological treatment or care as usual (CAU). We hypothesize that the intervention will be superior to CAU in reducing depressive symptoms assessed with the Personal Health Questionnaire (PHQ-9, primary outcome measure) following the intervention (12 wks) and at follow-up (24 and 48 wks). Further outcome parameters include quality of life, use of health care resources and attitude towards online psychological treatments. Discussion: The study will yield meaningful answers to the question of whether online psychological treatment can contribute to the effective and efficient prevention and treatment of mild to moderate depression on a population level with a low barrier to entry

The InterHerz project - a web-based psychological treatment for cardiac patients with depression: study protocol of a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Patients with heart disease often suffer from difficulties in psychological adaptation during cardiac rehabilitation. Mood disorders such as depression are known to be highly prevalent in cardiac patients and to have a negative impact on the progression of coronary heart disease. However, cardiac patients have difficulties to get psychological treatments due to low availability and motivational difficulties. Web-based interventions have been proven to be effective in treating depressive symptoms. Deprexis is a promising web-based psychological treatment which was devised for depressed patients. The aim of the study InterHerz is to examine if Deprexis is an effective psychological treatment to reduce stress and depression in cardiac patients.</p> <p>Methods/Design</p> <p>The sample will consist of 80 depressed patients randomized to an intervention group or a waitlist (10 weeks). Patients are recruited via cardiologists, cardiac rehabilitation units and the website of the Swiss Heart Foundation. Patients have access to a guided self-help program in which they work themselves through several modules and receive feedback from a clinical psychologist. Pre- and post-assessments, and a six-month follow-up, are conducted using online questionnaires and diagnostic interviews.</p> <p>Discussion</p> <p>Deprexis is a new web-based treatment which has the potential to help depressed cardiac patients with limited access to psychological treatment to increase their mental health.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN45945396</p