The reconsolidation using rewind study (RETURN): trial protocol

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 crossover 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 El estudio Reconsolidación Usando Rebobinado (RETURN): protocolo de pruebaAntecedentes: Un creciente cuerpo de investigación destaca las terapias basadas en la reconsolidación como tratamientos emergentes para el trastorno de estrés postraumático (TEPT). La Técnica de Rebobinado es una terapia no farmacológica basada en la reconsolidación con resultados tempranos prometedores, que ahora requiere evaluación a través de un ECA. Objetivos: Este es un ECA preliminar de eficacia para determinar si es probable que la técnica de rebobinado sea una candidata adecuada para probar en comparación con el cuidado habitual en un futuro ECA de eficacia pragmática. Método: 40 participantes serán asignados al azar para recibir la técnica de rebobinado inmediatamente o después de una espera de 8 semanas. El resultado primario será la gravedad de los síntomas del TEPT según lo medido por la Escala de TEPT administrada por el médico para DSM5 (CAPS-5 en su sigla en inglés) a las 8 y 16 semanas posteriores a la aleatorización. Las medidas de resultados secundarios incluyen la Lista de Verificación de TEPT (PCL-5 en su sigla en inglés), el Cuestionario Internacional de Trauma (ITQ en su sigla en inglés), el Cuestionario de Salud del Paciente (PHQ-9 en su sigla en inglés), el Trastorno de Ansiedad General-7 (GAD-7 en su sigla en inglés), el Índice de Gravedad del Insomnio, el Euro-Qol-5D (EQ5D-5L en su sigla en inglés), la prominencia de re-experimentar los síntomas específicos (CAPS-5) y un cuestionario de aceptabilidad de la intervención para medir la tolerabilidad de la intervención. Conclus...

Muss Rewind Therapy to alleviate symptoms related to some form of traumatic experience: A thematic analysis of participants' experiences and their perceived effectiveness of MRT

“…Such work could include greater use of a manualised approach in an attempt to maximise fidelity to the model and reduce contamination from other therapeutic approaches. Such work is underway within a randomised controlled trial (Astill Wright, Barawi, et al, 2021; Astill Wright, Horstmann, et al, 2021). However, in practice, MRT practitioners could benefit from a competency framework similar to those already existing for other therapies, such as the CBT competency frameworks underpinning CBT delivery within the English Increasing Access to Psychological Therapies (IAPT) programme (Roth & Pilling, 2007).…”

“…A therapy protocol modified from MRT training (IARTT, 2022a) was proposed for an RCT for MRT (Astill Wright, Barawi, et al, 2021;Astill Wright, Horstmann, et al, 2021). The protocol is reproduced below to help the reader understand how MRT is delivered and to contextualise the comments of the participants taking part in this study: "The participant is introduced to the technique and the theory behind it before being asked to imagine he/she is in a cinema watching a film of her/his traumatic event as if it had been captured on CCTV.…”

“…A therapy protocol modified from MRT training (IARTT, 2022a) was proposed for an RCT for MRT (Astill Wright, Barawi, et al, 2021; Astill Wright, Horstmann, et al, 2021). The protocol is reproduced below to help the reader understand how MRT is delivered and to contextualise the comments of the participants taking part in this study:…”

“…Once the recall ends, the participant is (metaphorically) invited to enter the screen, and at that point, the film is rewound at speed back to the exact starting point (where all was well before the trauma). The forward part of the process of recalling the trauma lasts no longer than 2 minutes, and the rewind part about 10 seconds” (Astill Wright, Horstmann, et al, 2021; Astill Wright, Barawi, et al, 2021, p. 5).…”

“…There is a specific emphasis in the introductory explanation that the client does not have to reveal any details of the experience itself. For the practitioners and therapists to feel confident that the technique has been undertaken correctly, participants are encouraged to practise it multiple times (Astill Wright, Barawi, et al, 2021; Astill Wright, Horstmann, et al, 2021).…”