German Depression Foundation, Semmelweisstr. 10, 04103, Leipzig, Germany.
European Alliance Against Depression, Semmelweisstr. 10, 04103, Leipzig, Germany.
BMC Psychiatry. 2019 Mar 14;19(1):90. doi: 10.1186/s12888-019-2063-1.
The 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/DESIGN: The 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.
This 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.
International 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).
重度抑郁症是一种高发性疾病，会给患者带来沉重的负担，它的治疗是全球医疗体系的一大挑战。基于互联网的自我管理干预措施似乎是一种具有成本效益的方法，可以补充对抑郁患者的治疗，但现有证据主要基于与候补对照组和常规治疗的比较，这可能导致对疗效的高估。此外，评估长期疗效和可能出现的负面结果的研究仍然很少。
方法/设计：本研究评估了 iFightDepression® 工具的德语文本与一种积极对照条件相比的疗效。共有 360 名轻度至中度抑郁症状的患者被纳入一项两臂随机对照试验。他们接受两种为期六周的干预措施之一：iFightDepression® 工具或渐进性肌肉松弛作为对照条件。两个干预组都收到信息材料、通过互联网每周的任务以及作为干预措施一部分的定期电话。主要结局是干预后抑郁症状的变化，用抑郁症状清单进行评估。满意度、可用性、感知生活质量的变化以及可能的负面效应作为次要结局进行评估。
本研究是 iFightDepression® 自我管理工具的德语文本的首个随机对照试验，旨在评估疗效，但也旨在提供对 E 心理健康计划中迄今研究较少的方面的新见解，即与积极对照条件相比治疗效果的特异性、12 个月时间内干预的连续性，以及这些基于互联网的干预的可能负面效应。
国际试验注册通过“国际临床试验注册平台”（世界卫生组织）进行，二级 ID 为 080-15-09032015。德国临床试验注册：DRKS00009323（DRKS.de，注册于 2016 年 2 月 25 日）。
