The REconsolidaTion Using RewiNd Study (RETURN): trial protocol

Astill Wright, Laurence ORCID: https://orcid.org/0000-0001-8324-1229, Barawi, Kali, Simon, Natalie, Lewis, Catrin ORCID: https://orcid.org/0000-0002-3818-9377, Muss, David, Roberts, Neil P., Kitchiner, Neil J. ORCID: https://orcid.org/0000-0003-0499-9520 and Bisson, Jonathan I. ORCID: https://orcid.org/0000-0001-5170-1243 2021. The REconsolidaTion Using RewiNd Study (RETURN): trial protocol. European Journal of Psychotraumatology 12 (1) , 1844439. 10.1080/20008198.2020.1844439

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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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	Taylor & Francis
ISSN:	2000-8066
Funders:	MRC
Date of First Compliant Deposit:	20 October 2020
Date of Acceptance:	19 October 2020
Last Modified:	06 Nov 2024 21:00
URI:	https://orca.cardiff.ac.uk/id/eprint/135762

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