The reconsolidation using rewind study (RETURN): trial protocol

Laurence Astill Wright, Kali Barawi, Natalie Simon, Catrin Lewis, David Muss, Neil P Roberts, Neil J Kitchiner, Jonathan I Bisson

Research output: Contribution to journalArticle (Academic Journal)peer-review

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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.

Trial registration: ISRCTN91345822
Original languageEnglish
Number of pages10
JournalEuropean Journal of Psychotraumatology
Volume12
Issue number1
DOIs
Publication statusPublished - 28 Jan 2021

Keywords

  • PTSD
  • RCT
  • Rewind Technique
  • Rewind Therapy
  • protocol

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