German Depression Foundation, Leipzig, Germany.
Department of Psychiatry and Psychotherapy, University Leipzig, Leipzig, Germany.
J Med Internet Res. 2020 Jul 14;22(7):e15361. doi: 10.2196/15361.
An increasing number of studies suggest that web-based interventions for patients with depression can reduce their symptoms and are expected to fill currently existing treatment gaps. However, evidence for their efficacy has mainly been derived from comparisons with wait-list or treatment as usual controls. In particular, designs using wait-list controls are unlikely to induce hope and may even have nocebo effects, making it difficult to draw conclusions about the intervention's efficacy. Studies using active controls are rare and have not yielded conclusive results.
The main objective of this study is to assess the acute and long-term antidepressant efficacy of a 6-week, guided, web-based self-management intervention building on the principles of cognitive behavioral therapy (iFightDepression tool) for patients with depression compared with web-based progressive muscle relaxation as an active control condition.
A total of 348 patients with mild-to-moderate depressive symptoms or dysthymia (according to the Mini International Neuropsychiatric Interview) were recruited online and randomly assigned to 1 of the 2 intervention arms. Acute antidepressant effects after 6 weeks and long-term effects at 3-, 6-, and 12-month follow-up were studied using the Inventory of Depressive Symptomatology-self-rating as a primary outcome parameter and change in quality of life (Short Form 12) and user satisfaction (client satisfaction questionnaire) as secondary outcome parameters. Treatment effects were assessed using mixed model analyses.
Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group. Separate tests for each time point revealed significant effects on depressive symptoms at the 3-month follow-up (d=0.281; 95% CI 0.069 to 0.493), but not after 6 weeks (main outcome:d=0.192; 95% CI -0.020 to 0.404) and 6 and 12 months. The intervention was significantly superior to the control condition with respect to user satisfaction (25.31 vs 21.97; t=5.804; P<.01).
The fact that antidepressant effects have been found for a guided self-management tool in comparison with an active control strengthens the evidence base for the efficacy of web-based interventions. The antidepressant effect became most prominent at the 3-month follow-up. After 6 weeks of intervention, significant positive effects were observed on life quality but not on depressive symptoms. Although the effect size of such web-based interventions on symptoms of depression might be smaller than that suggested by earlier studies using wait-list control conditions, they can be a cost-effective addition to antidepressants and face-to-face psychotherapy.
International Clinical Trials Registry Platform ICTRP080-15-09032015; https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00009323.
越来越多的研究表明，针对抑郁症患者的基于网络的干预措施可以减轻其症状，有望填补目前存在的治疗空白。然而，其疗效的证据主要来自与等待名单或常规治疗的对照比较。特别是，使用等待名单对照的设计不太可能产生希望，甚至可能产生反安慰剂效应，因此很难得出干预措施疗效的结论。使用活性对照的研究很少，且未得出结论性结果。
本研究的主要目的是评估基于认知行为疗法原理的 6 周指导性基于网络的自我管理干预（iFightDepression 工具）对轻度至中度抑郁症状或心境恶劣（根据 Mini 国际神经精神访谈）患者的急性和长期抗抑郁疗效，与基于网络的渐进性肌肉松弛作为活性对照条件。
共招募 348 名在线患者，将其随机分配至 2 个干预组之一。使用抑郁症状自评量表（Inventory of Depressive Symptomatology-self-rating）作为主要结局参数，以及生活质量（SF-12 短表）和用户满意度（客户满意度问卷）的变化作为次要结局参数，研究 6 周后的急性抗抑郁效果和 3、6 和 12 个月随访时的长期效果。使用混合模型分析评估治疗效果。
在整个观察期间，与活性对照组相比，干预组的抑郁症状减轻（P=.01）和生活质量改善（P<.001）更为明显。在每个时间点的单独测试中，在 3 个月随访时发现抑郁症状有显著效果（d=0.281；95%CI 0.069 至 0.493），但在 6 周（主要结局：d=0.192；95%CI -0.020 至 0.404）和 6 和 12 个月时没有效果。与对照组相比，干预组在用户满意度方面明显更优（25.31 对 21.97；t=5.804；P<.01）。
与活性对照相比，基于网络的自我管理工具的抗抑郁效果的发现增强了基于网络干预措施疗效的证据基础。抗抑郁效果在 3 个月随访时最为明显。在干预 6 周后，生活质量方面有显著的积极效果，但抑郁症状方面没有。尽管这种基于网络的干预措施对抑郁症症状的影响可能小于使用等待名单对照条件的早期研究中提示的效果，但它们可以作为抗抑郁药物和面对面心理治疗的一种具有成本效益的补充。
国际临床试验注册平台 ICTRP080-15-09032015；https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00009323。
