Klein Jan Philipp, Berger Thomas, Schröder Johanna, Späth Christina, Meyer Björn, Caspar Franz, Lutz Wolfgang, Arndt Alice, Greiner Wolfgang, Gräfe Viola, Hautzinger Martin, Fuhr Kristina, Rose Matthias, Nolte Sandra, Löwe Bernd, Anderssoni Gerhard, Vettorazzi Eik, Moritz Steffen, Hohagen Fritz
Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Psychother Psychosom. 2016;85(4):218-28. doi: 10.1159/000445355. Epub 2016 May 27.
Mild to moderate depressive symptoms are common but often remain unrecognized and treated inadequately. We hypothesized that an Internet intervention in addition to usual care is superior to care as usual alone (CAU) in the treatment of mild to moderate depressive symptoms in adults.
This trial was controlled, randomized and assessor-blinded. Participants with mild to moderate depressive symptoms (Patient Health Questionnaire, PHQ-9, score 5-14) were recruited from clinical and non-clinical settings and randomized to either CAU or a 12-week Internet intervention (Deprexis) adjunctive to usual care. Outcomes were assessed at baseline, 3 months (post-assessment) and 6 months (follow-up). The primary outcome measure was self-rated depression severity (PHQ-9). The main analysis was based on the intention-to-treat principle and used linear mixed models.
A total of 1,013 participants were randomized. Changes in PHQ-9 from baseline differed signixFB01;cantly between groups (t825 = 6.12, p < 0.001 for the main effect of group). The post-assessment between-group effect size in favour of the intervention was d = 0.39 (95% CI: 0.13-0.64). It was stable at follow-up, with d = 0.32 (95% CI: 0.06-0.69). The rate of participants experiencing at least minimally clinically important PHQ-9 change at the post-assessment was higher in the intervention group (35.6 vs. 20.2%) with a number needed to treat of 7 (95% CI: 5-10).
The Internet intervention examined in this trial was superior to CAU alone in reducing mild to moderate depressive symptoms. The magnitude of the effect is clinically important and has public health implications.
轻度至中度抑郁症状很常见,但往往未被识别且治疗不充分。我们假设,在常规护理基础上增加互联网干预,在治疗成人轻度至中度抑郁症状方面优于单纯常规护理(CAU)。
本试验为对照、随机且评估者盲法试验。从临床和非临床环境中招募有轻度至中度抑郁症状(患者健康问卷,PHQ-9,得分5-14)的参与者,并随机分为CAU组或在常规护理基础上进行为期12周的互联网干预(Deprexis)组。在基线、3个月(评估后)和6个月(随访)时评估结果。主要结局指标为自评抑郁严重程度(PHQ-9)。主要分析基于意向性分析原则,并使用线性混合模型。
共1013名参与者被随机分组。两组间PHQ-9从基线的变化有显著差异(组间主效应的t825 = 6.12,p < 0.001)。评估后干预组的组间效应大小为d = 0.39(95%CI:0.13-0.64)。随访时保持稳定,d = 0.32(95%CI:0.06-0.69)。干预组在评估后经历至少具有最小临床重要性的PHQ-9变化的参与者比例更高(35.6%对20.2%),治疗所需人数为7(95%CI:5-10)。
本试验中研究的互联网干预在减轻轻度至中度抑郁症状方面优于单独的CAU。该效应大小具有临床重要性且对公共卫生有影响。