Introduction: 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. Objective: 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. Methods: This is an observer-masked, multicenter, pragmatic randomized controlled trial with a randomization ratio of 1:1.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. Results: Between October 2015 and July 2017, we randomly assigned 210 participants (IG, n = 105; CG, n = 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 (p #x3c; 0.05). Health-related quality of life was significantly higher in the IG. No differences were found in work capacity. Conclusion: 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.
Psychother Psychosom

中文翻译：

---

基于互联网和移动设备的指导干预对慢性背痛和抑郁症 (WARD-BP) 患者的有效性：一项多中心、务实的随机对照试验

简介：既没有强有力的证据表明对慢性背痛 (CBP) 和抑郁症患者的有效治疗，也没有足够的心理保健服务。目的：目的是评估基于互联网和移动的干预 (IMI) 作为在常规护理环境中治疗抑郁症的可扩展方法的有效性。方法：这是一项不设观察的、多中心、务实的随机对照试验，随机化比例为 1:1。从德国各地的 82 家骨科康复诊所招募了患有 CBP 并诊断为抑郁症（轻度至中度）的患者。干预组 (IG) 在照常治疗 (TAU；包括药物治疗) 后接受了针对 CBP 量身定制的指导性抑郁 IMI，而对照组 (CG) 接受了 TAU。主要结果是观察者掩蔽的临床医生评定的汉密尔顿抑郁严重程度（9 周随访）。次要结果是：进一步的抑郁结果、与疼痛相关的结果、与健康相关的生活质量和工作能力。使用回归模型的生物统计学盲法分析是通过意向治疗和按方案分析进行的。结果： 2015 年 10 月至 2017 年 7 月期间，我们随机分配了 210 名参与者（IG，n = 105；CG，n = 105），大多数情况下只有轻微的疼痛强度但严重的疼痛失能。在 9 周的随访中，未观察到 IG 和 CG 之间抑郁严重程度的统计学显着差异（β = –0.19，95% CI –0.43 至 0.05）。探索性继发性抑郁 (4/9) 和疼痛相关 (4/6) 结果部分显着 ( p #x3c; 0.05)。IG 的健康相关生活质量显着更高。在工作能力方面没有发现差异。结论：结果表明，在常规护理环境中对 CBP 和抑郁症患者进行 IMI 对抑郁症的影响有限。疼痛和健康相关结果的益处表明 IMI 可能仍然是改善常规护理的有用措施。
心理咨询师