Department of Clinical, Neuro- and Developmental Psychology and World Health Organization Collaborating Center for Research and Dissemination of Psychological Interventions, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
Department of Psychiatry, Stellenbosch University, Cape Town, Western Cape, South Africa.
BMJ Open. 2022 Feb 15;12(2):e054830. doi: 10.1136/bmjopen-2021-054830.
Several evidence-based treatments are effective for post-traumatic stress disorder (PTSD), yet a substantial proportion of patients do not respond or dropout of treatment. We describe the protocol for a systematic review and individual participant data meta-analysis (IPD-MA) aimed at assessing the effectiveness and adverse effects of psychotherapy and pharmacotherapy interventions for treating PTSD. Additionally, we seek to examine moderators and predictors of treatment outcomes.
This IPD-MA includes randomised controlled trials comparing psychotherapy and pharmacotherapy interventions for PTSD. PubMed, Embase, PsycINFO, PTSDpubs and CENTRAL will be screened up till the 11th of January 2021. The target population is adults with above-threshold baseline PTSD symptoms on any standardised self-report measure. Trials will only be eligible if at least 70% of the study sample have been diagnosed with PTSD by means of a structured clinical interview. The primary outcomes of this IPD-MA are PTSD symptom severity, and response rate. Secondary outcomes include treatment dropout and adverse effects. Two independent reviewers will screen major bibliographic databases and past reviews. Authors will be contacted to contribute their participant-level datasets. Datasets will be merged into a master dataset. A one-stage IPD-MA will be conducted focusing on the effects of psychological and pharmacological interventions on PTSD symptom severity, response rate, treatment dropout and adverse effects. Subsequent analyses will focus on examining the effect of moderators and predictors of treatment outcomes. These will include sociodemographic, treatment-related, symptom-related, resilience, intervention, trauma and combat-related characteristics. By determining the individual factors that influence the effectiveness of specific PTSD treatments, we will gain insight into personalised treatment options for PTSD.
Specific ethics approval for an IPD-MA is not required as this study entails secondary analysis of existing anonymised data. The results of this study will be published in peer-reviewed scientific journals and presentations.
有几种循证治疗方法对创伤后应激障碍（PTSD）有效，但仍有相当一部分患者对治疗没有反应或中途退出。我们描述了一项系统评价和个体参与者数据荟萃分析（IPD-MA）的方案，旨在评估心理治疗和药物治疗干预治疗 PTSD 的有效性和不良反应。此外，我们还试图研究治疗结果的调节因素和预测因素。
这项 IPD-MA 包括比较 PTSD 的心理治疗和药物治疗干预的随机对照试验。我们将筛选 PubMed、Embase、PsycINFO、PTSDpubs 和 CENTRAL，截至 2021 年 1 月 11 日。目标人群是任何标准化自我报告量表上 PTSD 症状超过阈值的成年人。只有至少 70%的研究样本通过结构化临床访谈被诊断为 PTSD 的试验才有资格入选。这项 IPD-MA 的主要结果是 PTSD 症状严重程度和反应率。次要结果包括治疗脱落和不良反应。两名独立的审查员将筛选主要的文献数据库和过去的综述。作者将被联系以提供他们的参与者水平数据集。数据集将合并到一个主数据集中。我们将进行一项 IPD-MA，重点关注心理和药物干预对 PTSD 症状严重程度、反应率、治疗脱落和不良反应的影响。随后的分析将集中在检查治疗结果的调节因素和预测因素上。这些因素将包括社会人口统计学、治疗相关、症状相关、恢复力、干预、创伤和战斗相关特征。通过确定影响特定 PTSD 治疗效果的个体因素，我们将深入了解 PTSD 的个性化治疗选择。
由于这项研究是对现有匿名数据的二次分析，因此不需要专门的 IPD-MA 伦理批准。本研究的结果将发表在同行评议的科学期刊和演讲中。
