Institute of Psychology, Department of Rehabilitation Psychology and Psychotherapy, Albert-Ludwigs-University of Freiburg, Freiburg, Germany.
Institute for Sports and Sport Science, Department of Sports Psychology, Albert-Ludwigs-University of Freiburg, Freiburg, Germany.
JAMA Psychiatry. 2020 Oct 1;77(10):1001-1011. doi: 10.1001/jamapsychiatry.2020.1021.
Depression is a frequent comorbid condition in patients with persistent back pain and is associated with substantial adverse consequences, including the risk of developing opioid use disorders. Shifting the focus from depression treatment to preventing depression might be a viable way to reduce the disease burden.
To evaluate the effectiveness of a web-based self-help intervention to reduce the incidence of major depressive episode (MDE) in patients with persistent back pain.
DESIGN, SETTING, AND PARTICIPANTS: Prevention of Depression in Back Pain Patients (PROD-BP) was a pragmatic, observer-blinded randomized clinical trial with a parallel design conducted in Germany. Eligible adults with a diagnosis of persistent back pain and subclinical depressive symptoms, but who were depression free, were recruited either on-site or after discharge from 82 orthopedic clinics between October 1, 2015, and July 31, 2017. All analyses were conducted according to the intention-to-treat principle from October 31, 2018, to April 30, 2019.
The intervention group received an e-coach-guided, web-based self-help intervention that was based on cognitive behavioral therapy and tailored to the needs of patients with persistent back pain. The intervention included 6 obligatory modules and 3 optional modules to be completed by participants as well as feedback from e-coaches. Both the intervention and control groups had unrestricted access to treatment as usual.
Primary outcome was time to onset of an MDE over a 12-month period as assessed by blinded diagnostic raters using the Structured Clinical Interview for DSM-5. Secondary outcomes included depression severity, quality of life, pain intensity, pain-related disability, pain self-efficacy, work capacity, and user satisfaction assessed with a variety of instruments.
A total of 295 participants (mean [SD] age, 52.8 [7.7] years; 184 women [62.4%]) were recruited and randomized to either the intervention group (n = 149) or control group (n = 146). The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P < .001). Twenty-one participants (14.1%) in the intervention group and 41 participants (28.1%) in the control group experienced an MDE over the 12-month period. The number needed to treat to prevent 1 new case of MDE was 2.84 (95% CI, 1.79-9.44).
Results of this trial showed that among patients with persistent back pain, depression can be prevented by a guided web-based self-help intervention in addition to treatment as usual. This finding suggests that using a scalable digital approach to integrate psychological treatment into routine pain management is feasible.
German Clinical Trials Register Identifier: DRKS00007960.
抑郁症是持续性背痛患者的常见合并症，与大量不良后果相关，包括发展为阿片类药物使用障碍的风险。将关注重点从抑郁治疗转移到预防抑郁可能是减轻疾病负担的可行方法。
评估基于网络的自助干预措施在预防持续性背痛患者发生重度抑郁发作（MDE）中的有效性。
设计、地点和参与者：预防背痛患者的抑郁（PROD-BP）是一项在德国进行的具有平行设计的实用、观察者盲法随机临床试验。2015 年 10 月 1 日至 2017 年 7 月 31 日，从 82 家骨科诊所招募了符合持续性背痛和亚临床抑郁症状诊断但无抑郁病史的成年人。所有分析均按照意向治疗原则进行，时间为 2018 年 10 月 31 日至 2019 年 4 月 30 日。
干预组接受了基于认知行为疗法并针对持续性背痛患者需求定制的电子教练指导的基于网络的自助干预。该干预包括 6 个强制性模块和 3 个可选模块，供参与者完成，并由电子教练提供反馈。干预组和对照组都可以不受限制地获得常规治疗。
主要结局是通过盲法诊断评估者在 12 个月内发生 MDE 的时间。次要结局包括抑郁严重程度、生活质量、疼痛强度、与疼痛相关的残疾、疼痛自我效能、工作能力和用户满意度，使用各种工具进行评估。
共招募了 295 名参与者（平均[标准差]年龄为 52.8[7.7]岁；184 名女性[62.4%]），并随机分为干预组（n = 149）或对照组（n = 146）。干预组 MDE 发病风险降低了 52%（风险比，0.48；95%置信区间，0.28-0.81；P < 0.001）。干预组中有 21 名（14.1%）参与者和对照组中有 41 名（28.1%）参与者在 12 个月内发生了 MDE。预防 1 例新 MDE 所需的治疗人数为 2.84（95%置信区间，1.79-9.44）。
这项试验的结果表明，在持续性背痛患者中，除了常规治疗外，还可以通过引导式基于网络的自助干预来预防抑郁。这一发现表明，使用可扩展的数字方法将心理治疗纳入常规疼痛管理是可行的。
德国临床试验注册中心标识符：DRKS00007960。
