Reducing the incidence of depression for patients with back pain and subclinical depression using an internet- and mobile-based intervention– Follow-up assessment of a pragmatic randomized controlled large-scale trial

使用基于互联网和移动设备的干预措施降低背痛和亚临床抑郁症患者的抑郁症发病率â 一项实用随机对照大型试验的后续评估

基本信息

项目摘要

Background: Prevention of major depression (MDD) is of major public health relevance. However, most depression prevention trials worldwide lack appropriate follow-up assessments that include clinical interviews to assess the incidence of MDD. Within the framework of the WARD-BP study, funded by the BMBF, we established a so far self-funded prevention side-study called PROD-BP (Prevention of Depression in Back Pain Patients). As the funding of WARD-BP and the possibility of self-funding ends, PROD-BP will end with a post-treatment assessment. With a 12-months follow-up, however, PROD-BP would become the first large-scale depression prevention trial in this field. Methods: PROD-BP 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 with subthreshold depressive symptoms. The investigated intervention 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 and supervised psychologists provide guidance by sending feedback messages after each module. A total of 295 patients with chronic back pain without a clinician rated depressive disorder at baseline (PHQ ≥ 5; no SCID-5 depression diagnosis) have been recruited following orthopedic rehabilitation care and allocated to either intervention or treatment-as-usual (TAU) until July 2017, making the self-funded PROD-BP-study to one of the largest depression prevention trials ever conducted. Primary outcome is depression onset (SCID-5 diagnosis) at 12 months follow-up. Key secondary outcomes are quality of life, depression severity, pain intensity and disability, ability to work, intervention satisfaction and adherence as well as side effects of the intervention and costs. PROD-BP was designed and conducted following the highest methodological standards, supported by the methodological rigor of the large-scale, multi-centre WARD-BP study. Online assessments are scheduled at baseline and 9 weeks (already conducted until October 2017), 6 months and 12 months post-randomization. In the present applied funding period the assessment of the primary outcome and the medium- and long-term secondary outcomes takes place, as well as data clearance and data analyses and dissemination of results. Discussion: The PROD-BP trial is the first examining an IMI for depression prevention in a sample of chronic pain patients. It is implemented into routine orthopedic health care, specifically tailored to the sample of chronic back pain patients and very unusually well powered. With the proposed grant PROD-BP would be uplifted to become a landmark study in its field at relatively low costs.
背景:预防重性抑郁症(MDD)具有重大的公共卫生意义。然而,世界范围内大多数抑郁症预防试验缺乏适当的随访评估,包括评估MDD发病率的临床访谈。在由BMBF资助的WARD-BP研究框架内,我们建立了一个迄今为止自筹资金的预防副研究,称为PROD-BP(预防背痛患者抑郁)。随着WARD-BP的供资和自筹资金的可能性结束,PROD-BP将以治疗后评估结束。然而,经过12个月的随访,PROD-BP将成为该领域第一个大规模的抑郁症预防试验。研究方法:PROD-BP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)预防慢性背痛伴阈下抑郁症状患者抑郁的(成本)效果。研究的干预措施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预防干预措施,包括每周六次加上三个可选模块和两次强化治疗。经过培训和监督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,共招募了295名基线时无临床医生评定的抑郁障碍(PHQ ≥ 5;无SCID-5抑郁诊断)的慢性背痛患者,并将其分配至干预或常规治疗(TAU),直至2017年7月,使自费PROD-BP研究成为有史以来最大的抑郁预防试验之一。主要结局是12个月随访时抑郁发作(SCID-5诊断)。关键的次要结局是生活质量、抑郁严重程度、疼痛强度和残疾、工作能力、干预满意度和依从性以及干预的副作用和成本。PROD-BP的设计和实施遵循最高的方法学标准,并得到大规模、多中心WARD-BP研究方法学严谨性的支持。计划在基线和随机化后9周(已进行至2017年10月)、6个月和12个月进行在线评估。在目前的申请资助期内,将对主要成果和中长期次要成果进行评估,并进行数据清理和数据分析以及成果传播。讨论:PROD-BP试验是第一个在慢性疼痛患者样本中检查IMI预防抑郁的试验。它被实施到常规骨科医疗保健中,专门针对慢性背痛患者的样本量身定制,并且非常具有良好的动力。有了拟议的赠款,PROD-BP将以相对较低的成本成为该领域的里程碑式研究。

项目成果

期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Effectiveness of a Guided Web-Based Self-help Intervention to Prevent Depression in Patients With Persistent Back Pain: The PROD-BP Randomized Clinical Trial.
基于网络的引导式自助干预对预防持续性背痛患者抑郁的有效性:PROD-BP 随机临床试验
  • DOI:
    10.1001/jamapsychiatry.2020.1021
  • 发表时间:
    2020
  • 期刊:
  • 影响因子:
    25.8
  • 作者:
    Sander L;Paganini S;Terhorst Y;Schlicker S;Spanhel K;Buntrock C;Ebert DD;Baumeister H
  • 通讯作者:
    Baumeister H
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Professor Dr. Harald Baumeister其他文献

Professor Dr. Harald Baumeister的其他文献

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{{ truncateString('Professor Dr. Harald Baumeister', 18)}}的其他基金

Entwicklung und Validierung eines computer-adaptiven Tests zu Vermeidend-Selbstunsicheren und Zwanghaften Persönlichkeitsstörungen - CAT-PS
针对回避型不安全型人格障碍和强迫型人格障碍的计算机自适应测试的开发和验证 - CAT-PS
  • 批准号:
    221626058
  • 财政年份:
    2012
  • 资助金额:
    --
  • 项目类别:
    Research Grants
Subtypes of unipolar depressive disorders in patients with coronary artery disease
冠状动脉疾病患者的单相抑郁症亚型
  • 批准号:
    179593206
  • 财政年份:
    2010
  • 资助金额:
    --
  • 项目类别:
    Research Fellowships

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眼表菌群影响糖尿病患者干眼发生的人群流行病学研究
  • 批准号:
    82371110
  • 批准年份:
    2023
  • 资助金额:
    49.00 万元
  • 项目类别:
    面上项目

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