Effectiveness and cost-effectiveness of a guided Internet- and mobile-based intervention for the indicated prevention of major depression in patients with chronic back pain-study protocol of the PROD-BP multicenter pragmatic RCT.
Effectiveness and cost-effectiveness of a guided Internet- and mobile-based intervention for the indicated prevention of major depression in patients with chronic back pain-study protocol of the PROD-BP multicenter pragmatic RCT.
复制标题
具有指导性的互联网和移动性干预措施的有效性和成本效益，以预示预防Prod BP多中心务实RCT的慢性背部疼痛协议患者的严重抑郁症。
DOI：
10.1186/s12888-017-1193-6
复制
发表时间：
2017-01-21
期刊：
影响因子：
4.4
通讯作者：
Baumeister H
中科院分区：
文献类型：
--
作者：
Sander L;Paganini S;Lin J;Schlicker S;Ebert DD;Buntrock C;Baumeister H
减轻重性抑郁症（MDD）的疾病负担具有重大的公共卫生意义。预防抑郁症被认为是实现这一目标的一种可能方法。有多种MDD风险因素的人，如慢性背痛和阈下抑郁症状，可能从预防措施中获益最多。互联网作为干预环境，可以在公共心理健康层面上扩大预防干预。本研究是一项平行设计的多中心实用随机对照试验（RCT），旨在研究基于互联网和移动设备的干预（IMI）预防具有阈下抑郁症状的慢性背痛患者（PROD-BP）抑郁的（成本）效果。eSano BackCare-DP是一种基于认知行为疗法（CBT）原则的指导性慢性背痛特异性抑郁症预防干预，包括每周六次，外加三个可选模块和两次强化治疗。经过培训的心理学家通过在每个模块后发送反馈信息提供指导。在骨科康复护理后，将招募共406例基线时患有慢性背痛且无抑郁障碍的患者，并将其分配至干预组或常规治疗组（TAU）。本试验的主要患者相关终点是基线和随机化后1年通过电话管理的DSM结构化临床访谈（SCID）测量的至MDD发作的时间。关键的次要结局是健康相关的生活质量、抑郁严重程度、疼痛强度、疼痛相关残疾、工作能力、干预满意度和依从性以及干预的副作用。在线评估在基线和9周以及随机化后6个月和12个月进行。将进行考克斯回归生存分析，以估计12个月随访时的风险比。此外，还将从社会和公共卫生的角度进行经济分析。这是第一个研究IMI在慢性疼痛患者样本中预防抑郁症的研究。如果将抑郁症预防IMI应用于骨科术后护理被证明是有效的，那么这种干预措施可以以最低的成本整合到常规护理中，并扩展到其他慢性疾病。研究结果将对研究人员、卫生保健提供者和公共卫生政策制定者产生影响。该试验通过德国临床研究试验注册中心（DRKS）在WHO国际临床试验注册平台注册：DRKS 00007960。2015年8月12日注册。
Reducing the disease burden of major depressive disorder (MDD) is of major public health relevance. The prevention of depression is regarded as one possible approach to reach this goal. People with multiple risk factors for MDD such as chronic back pain and subthreshold depressive symptoms may benefit most from preventive measures. The Internet as intervention setting allows for scaling up preventive interventions on a public mental health level. This study is a multicenter pragmatic randomized controlled trial (RCT) of parallel design aiming to investigate the (cost-) effectiveness of an Internet- and mobile-based intervention (IMI) for the prevention of depression in chronic back pain patients (PROD-BP) with subthreshold depressive symptoms. eSano BackCare-DP is a guided, chronic back pain-specific depression prevention intervention based on cognitive behavioral therapy (CBT) principles comprising six weekly plus three optional modules and two booster sessions after completion of the intervention. Trained psychologists provide guidance by sending feedback messages after each module. A total of 406 patients with chronic back pain and without a depressive disorder at baseline will be recruited following orthopedic rehabilitation care and allocated to either intervention or treatment-as-usual (TAU). Primary patient-relevant endpoint of the trial is the time to onset of MDD measured by the telephone-administered Structured Clinical Interview for DSM (SCID) at baseline and 1-year post-randomization. Key secondary outcomes are health-related quality of life, depression severity, pain intensity, pain-related disability, ability to work, intervention satisfaction and adherence as well as side effects of the intervention. Online assessments take place at baseline and 9 weeks as well as 6 and 12 months post-randomization. Cox regression survival analysis will be conducted to estimate hazard ratio at 12-month follow-up. Moreover, an economic analysis will be conducted from a societal and public health perspective. This is the first study examining an IMI for depression prevention in a sample of chronic pain patients. If this implementation of a depression prevention IMI into orthopedic aftercare proves effective, the intervention could be integrated into routine care with minimal costs and extended for use with other chronic diseases. Results will have implications for researchers, health care providers and public health policy makers. The trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (DRKS): DRKS00007960. Registered 12 August 2015.