Mewes Lisa, Langhammer Till, Torbecke Jonathan, Fendel Johannes Caspar, Lueken Ulrike
Department of Psychology, Humboldt-Universitat zu Berlin, Berlin, Germany.
PartnerSite Berlin/Potsdam, Deutsches Zentrum für Psychische Gesundheit, Berlin, Germany.
BMJ Open. 2025 May 21;15(5):e090571. doi: 10.1136/bmjopen-2024-090571.
Despite the established status of trauma-focused psychotherapy (TFP) as a first-line treatment for post-traumatic stress disorder (PTSD), a substantial proportion of individuals do not achieve clinically significant improvement or discontinue treatment. Exploring augmentation strategies to enhance treatment outcomes is essential to reduce the overall burden PTSD puts on individuals and society. This protocol outlines a systematic review and meta-analysis of randomised controlled trials (RCTs) evaluating the efficacy of non-pharmacological augmentation strategies in addition to TFP for PTSD treatment.
We comprehensively searched PubMed, Embase, CENTRAL, PTSDpubs, PsycArticles, PsycINFO, PSYNDEX and CINAHL for RCTs without restrictions on publication dates or languages in October 2024. Study screening is currently ongoing. Additionally, we will perform forward and backward searches of the included studies and relevant reviews. Two reviewers will independently screen and select studies, extract data and assess the risk of bias. We will conduct a narrative review to qualitatively synthesise data and a meta-analysis to quantitatively compare the treatment efficacy of augmented TFP with TFP alone or TFP plus placebo. Primary outcomes will be both symptom severity and response rates. The secondary outcome will be dropout rates. We will explore sources of between-study heterogeneity and potential moderators through subgroup and meta-regression analyses. We will assess the overall quality of the included studies with the Grading of Recommendations Assessment, Development, and Evaluation system.
Ethical approval is not required. We intend to publish results in a peer-reviewed journal and provide materials and data through the Open Science Framework.
CRD42024549435.
尽管创伤聚焦心理治疗（TFP）作为创伤后应激障碍（PTSD）的一线治疗方法已确立其地位，但仍有相当一部分患者未取得具有临床意义的改善或中断治疗。探索增强治疗效果的强化策略对于减轻PTSD给个人和社会带来的总体负担至关重要。本方案概述了一项系统评价和荟萃分析，该分析针对评估除TFP外的非药物强化策略对PTSD治疗效果的随机对照试验（RCT）。
2024年10月，我们全面检索了PubMed、Embase、CENTRAL、PTSDpubs、PsycArticles、PsycINFO、PSYNDEX和CINAHL，以查找对发表日期和语言无限制的RCT。研究筛选工作目前正在进行中。此外，我们将对纳入的研究和相关综述进行向前和向后检索。两名评审员将独立筛选和选择研究、提取数据并评估偏倚风险。我们将进行叙述性综述以定性综合数据，并进行荟萃分析以定量比较强化TFP与单纯TFP或TFP加安慰剂的治疗效果。主要结局将是症状严重程度和缓解率。次要结局将是脱落率。我们将通过亚组分析和荟萃回归分析探索研究间异质性的来源和潜在的调节因素。我们将使用推荐分级评估、制定和评价系统评估纳入研究的整体质量。
无需伦理批准。我们打算在同行评审期刊上发表研究结果，并通过开放科学框架提供材料和数据。
PROSPERO注册号：CRD42024549435。
