Department of Psychiatry and Amsterdam Public Health research institute, Amsterdam University Medical Centre - Location AMC, Amsterdam, The Netherlands
Institute of Health Research, College of Medicine & Health, University of Exeter, Exeter, UK.
BMJ Open. 2020 Feb 13;10(2):e034158. doi: 10.1136/bmjopen-2019-034158.
Psychological interventions and antidepressant medication can be effective interventions to prevent depressive relapse for patients currently in remission of depression. Less is known about overall factors that predict or moderate treatment response for patients receiving a psychological intervention for recurrent depression. This is a protocol for an individual participant data (IPD) meta-analysis which aims to assess predictors and moderators of relapse or recurrence for patients currently in remission from depression.
Searches of PubMed, PsycINFO, Embase and Cochrane Central Register of Controlled Trials were completed on 13 October 2019. Study extractions and risk of bias assessments have been completed. Study authors will be asked to contribute IPD. Standard aggregate meta-analysis and IPD analysis will be conducted, and the outcomes will be compared with assess whether results differ between studies supplying data and those that did not. IPD files of individual data will be merged and variables homogenised where possible for consistency. IPD will be analysed via Cox regression and one and two-stage analyses will be conducted.
The results will be published in peer review journals and shared in a policy briefing as well as accessible formats and shared with a range of stakeholders. The results will inform patients and clinicians and researchers about our current understanding of more personalised ways to prevent a depressive relapse. No local ethics approval was necessary following consultation with the legal department. Guidance on patient data storage and management will be adhered to.
CRD42019127844.
心理干预和抗抑郁药物治疗对于预防抑郁缓解期患者的抑郁复发可能是有效的干预措施。对于接受复发性抑郁症心理干预的患者,预测或调节治疗反应的总体因素知之甚少。这是一项个体参与者数据(IPD)荟萃分析的方案,旨在评估目前缓解期的抑郁患者复发或复发的预测因素和调节因素。
于 2019 年 10 月 13 日完成了对 PubMed、PsycINFO、Embase 和 Cochrane 对照试验中心注册库的搜索。已完成研究提取和偏倚风险评估。将要求研究作者提供 IPD。将进行标准综合荟萃分析和 IPD 分析,并比较结果,以评估提供数据的研究和未提供数据的研究之间的结果是否存在差异。将合并 IPD 文件的个体数据,并在可能的情况下对变量进行统一化,以保持一致性。将通过 Cox 回归分析 IPD,并进行单阶段和两阶段分析。
研究结果将在同行评议期刊上发表,并以政策简报以及可访问的格式共享,并与一系列利益相关者共享。结果将使患者、临床医生和研究人员了解我们目前对预防抑郁复发的更个性化方法的理解。与法律部门协商后,无需进行当地伦理批准。将遵守有关患者数据存储和管理的指南。
PROSPERO 注册号:CRD42019127844。