Supplementary Material for: Effectiveness of a Guided Internet- and Mobile-Based Intervention for Patients with Chronic Back Pain and Depression (WARD-BP): A Multicenter, Pragmatic Randomized Controlled Trial

<b><i>Introduction:</i></b> There is neither strong evidence on effective treatments for patients with chronic back pain (CBP) and depressive disorder nor sufficiently available mental health care offers. <b><i>Objective:</i></b> The aim is to assess the effectiveness of internet- and mobile-based interventions (IMI) as a scalable approach for treating depression in a routine care setting. <b><i>Methods:</i></b> This is an observer-masked, multicenter, pragmatic randomized controlled trial with a randomization ratio of 1:1.<b><i></i></b>Patients with CBP and diagnosed depressive disorder (mild to moderate severity) were recruited from 82 orthopedic rehabilitation clinics across Germany. The intervention group (IG) received a guided depression IMI tailored to CBP next to treatment-as-usual (TAU; including medication), while the control group (CG) received TAU. The primary outcome was observer-masked clinician-rated Hamilton depression severity (9-week follow-up). The secondary outcomes were: further depression outcomes, pain-related outcomes, health-related quality of life, and work capacity. Biostatistician blinded analyses using regression models were conducted by intention-to-treat and per protocol analysis. <b><i>Results:</i></b> Between October 2015 and July 2017, we randomly assigned 210 participants (IG, <i>n</i> = 105; CG, <i>n</i> = 105), mostly with only a mild pain intensity but substantial pain disability. No statistically significant difference in depression severity between IG and CG was observed at the 9-week follow-up (β = –0.19, 95% CI –0.43 to 0.05). Explorative secondary depression (4/9) and pain-related (4/6) outcomes were in part significant (<i>p</i> &lt; 0.05). Health-related quality of life was significantly higher in the IG. No differences were found in work capacity. <b><i>Conclusion:</i></b> The results indicate that an IMI for patients with CBP and depression in a routine care setting has limited impact on depression. Benefits in pain and health-related outcomes suggest that an IMI might still be a useful measure to improve routine care.

<b><i>引言：</i></b> 目前尚无针对慢性背痛（chronic back pain, CBP）共患抑郁障碍患者的有效治疗方案的确凿证据，且可及的心理健康服务资源亦相对匮乏。
<b><i>研究目的：</i></b> 本研究旨在评估互联网及移动干预措施（internet- and mobile-based interventions, IMI）作为常规医疗场景下可规模化开展的抑郁治疗手段的有效性。
<b><i>研究方法：</i></b> 本研究为一项观察者设盲的多中心实用型随机对照试验，随机分配比例为1:1。研究从德国82家骨科康复诊所招募了确诊为轻中度抑郁障碍的慢性背痛患者。干预组（IG）在常规治疗（treatment-as-usual, TAU，含药物治疗）基础上，接受针对慢性背痛定制的指导性抑郁互联网/移动干预措施；对照组（CG）仅接受常规治疗。本研究的主要结局指标为设盲临床医师评定的汉密尔顿抑郁严重程度评分（9周随访时）。次要结局指标包括：其他抑郁相关结局、疼痛相关结局、健康相关生存质量及工作能力。由设盲的生物统计学家采用回归模型，分别通过意向性治疗分析（intention-to-treat, ITT）和符合方案分析（per protocol analysis）进行统计分析。
<b><i>研究结果：</i></b> 2015年10月至2017年7月期间，本研究共随机纳入210名受试者（干预组n=105，对照组n=105），多数受试者仅表现为轻度疼痛强度，但存在显著的疼痛功能障碍。9周随访时，干预组与对照组的抑郁严重程度未观察到统计学显著性差异（β=-0.19，95%置信区间：-0.43~0.05）。探索性分析显示，9项次要抑郁结局指标中的4项、6项次要疼痛相关结局指标中的4项存在统计学显著性差异（p<0.05）。干预组的健康相关生存质量显著高于对照组。两组的工作能力无显著差异。
<b><i>研究结论：</i></b> 本研究结果表明，在常规医疗场景下，针对慢性背痛共患抑郁患者的互联网/移动干预措施对抑郁症状的改善效果有限。但在疼痛及健康相关结局方面的获益提示，此类干预措施仍可能成为改善常规医疗服务的有效手段。