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The reconsolidation using rewind study (RETURN): trial protocol
European Journal of Psychotraumatology ( IF 5.783 ) Pub Date : 2021-01-28 , DOI: 10.1080/20008198.2020.1844439
Laurence Astill Wright 1 , Kali Barawi 1 , Natalie Simon 1 , Catrin Lewis 1 , David Muss 2 , Neil P Roberts 1, 3 , Neil J Kitchiner 1, 3 , Jonathan I Bisson 1
Affiliation  

ABSTRACT

Background: An increasing body of research highlights reconsolidation-based therapies as emerging treatments for post-traumatic stress disorder (PTSD). The Rewind Technique is a non-pharmacological reconsolidation-based therapy with promising early results, which now requires evaluation through an RCT.

Objectives: This is a preliminary efficacy RCT to determine if the Rewind Technique is likely to be a good candidate to test against usual care in a future pragmatic efficacy RCT.

Methods: 40 participants will be randomised to receive either the Rewind Technique immediately, or after an 8 week wait. The primary outcome will be PTSD symptom severity as measured by the Clinician-Administered PTSD Scale for DSM5 (CAPS-5) at 8 and 16 weeks post-randomisation. Secondary outcome measures include the PTSD Checklist (PCL-5), International Trauma Questionnaire (ITQ), Patient Health Questionnaire (PHQ-9), the General Anxiety Disorder-7 (GAD-7), Insomnia Severity Index, the Euro-Qol-5D (EQ5D-5 L), the prominence of re-experiencing specific symptoms (CAPS-5) and an intervention acceptability questionnaire to measure tolerability of the intervention.

Conclusions: This study will be the first RCT to assess the Rewind Technique. Using a cross-over methodology we hope to rigorously assess the efficacy and tolerability of Rewind using pragmatic inclusion criteria. Potential challenges include participant recruitment and retention.

Trial registration: ISRCTN91345822



中文翻译:

使用倒带研究 (RETURN) 的再巩固:试验方案

摘要

背景:越来越多的研究强调基于再巩固的疗法是治疗创伤后应激障碍 (PTSD) 的新兴疗法。Rewind 技术是一种基于非药物再巩固的疗法,具有可喜的早期结果,现在需要通过 RCT 进行评估。

目标:这是一项初步疗效 RCT,以确定倒带技术是否可能成为未来实用疗效 RCT 中针对常规护理进行测试的良好候选者。

方法: 40 名参与者将被随机分配为立即接受倒带技术,或在等待 8 周后接受。主要结果将是 PTSD 症状的严重程度,在随机分组后 8 周和 16 周时,通过 DSM5 的临床医生管理的 PTSD 量表 (CAPS-5) 来衡量。次要结果测量包括 PTSD 检查表 (PCL-5)、国际创伤问卷 (ITQ)、患者健康问卷 (PHQ-9)、一般性焦虑症 7 (GAD-7)、失眠严重程度指数、Euro-Qol- 5D (EQ5D-5 L),重新体验特定症状的突出性 (CAPS-5) 和干预可接受性调查问卷以衡量干预的耐受性。

结论:本研究将是第一个评估倒带技术的随机对照试验。我们希望使用交叉方法,使用务实的纳入标准严格评估 Rewind 的疗效和耐受性。潜在的挑战包括参与者的招募和保留。

试用注册: ISRCTN91345822

更新日期:2021-02-23
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