Abstract
BackgroundThe treatment of major depressive disorder, a highly prevalent disorder associated with pronounced burden, is a large challenge to healthcare systems worldwide. Internet based self-management interventions seem to be a cost effective way to complement the treatment of depressed patients, but the accumulating evidence is mainly based on the comparison to waitlist controls and treatment as usual, which might lead to an overestimation of effects. Furthermore, studies assessing long-term effects and possible negative outcomes are still rare.Methods/DesignThe proposed study evaluates the efficacy of the German version of the iFightDepression® tool in comparison to an active control condition. A total of 360 patients with mild to moderate depressive symptoms are included into a two-armed randomized controlled trial. They receive one of two six week interventions; either the iFightDepression® tool or progressive muscle relaxation serving as the control condition. Both intervention groups receive information material, weekly tasks via the internet and regular phone calls as part of the intervention. The primary outcome is change in depressive symptoms after the intervention period, as measured with the Inventory of Depressive Symptomatology. Satisfaction with the program, usability, changes in perceived quality of life, and possible negative effects are assessed as secondary outcomes.DiscussionThis study represents the first randomized controlled trial on the iFightDepression® self-management tool in its German version, aiming at efficacy, but also at providing new insights into so far understudied aspects of E-mental health programs, namely the specificity of the treatment effect compared to an active control condition, it’s continuity over a time course of 12 months, and possible negative effects of these internet based interventions.Trial registrationInternational trial-registration took place through the “international clinical trials registry platform” (WHO) with the secondary ID 080–15-09032015. German Clinical Trial Registration: DRKS00009323 (DRKS.de, registered on 25 February 2016).
Highlights
The treatment of major depressive disorder, a highly prevalent disorder associated with pronounced burden, is a large challenge to healthcare systems worldwide
This study represents the first randomized controlled trial on the iFightDepression® self-management tool in its German version, aiming at efficacy, and at providing new insights into so far understudied aspects of E-mental health programs, namely the specificity of the treatment effect compared to an active control condition, it’s continuity over a time course of 12 months, and possible negative effects of these internet based interventions
Building on previous results indicating internet based interventions (IBIs) to be an effective treatment for depression, the results of the proposed study will further contribute to the understanding of IBIs as a supportive part of the treatment of depression
Summary
The treatment of major depressive disorder, a highly prevalent disorder associated with pronounced burden, is a large challenge to healthcare systems worldwide. While evidence-based treatments for depression are available (cognitive behavioral therapy (CBT) and pharmacotherapy [6]), not everyone affected by depression has access to these treatments or seeks help. Several reasons such as barriers in access to care and reluctance to seek help due to stigma are contributing to this situation [7]. Treatment adequacy has been found to be especially low in primary care [8] This affects a large number of patients (62,5%), who often receive treatment from their general practitioner (GP) after being diagnosed with depression [9]
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