Mixed-methods randomised study exploring the feasibility and acceptability of eye-movement desensitisation and reprocessing for improving the mental health of traumatised survivors of intensive care following hospital discharge: protocol.

INTRODUCTION: Post-traumatic symptoms are common among patients discharged from intensive care units (ICUs), adversely affecting well-being, increasing healthcare utilisation and delaying return to work. Non-pharmacological approaches (eg, music, therapeutic touch and patient diaries) have been suggested as candidate interventions and trauma-focused psychological interventions have been endorsed by international bodies. Neither category of intervention is supported by definitive evidence of long-term clinical effectiveness in patients who have been critically ill. This study assesses the feasibility and acceptability of using eye-movement desensitisation and reprocessing (EMDR) to improve the mental health of ICU survivors. METHODS AND ANALYSIS: EMERALD is a multicentre, two-part consent, pilot feasibility study, recruiting discharged ICU survivors from three hospitals in the UK. We are gathering demographics and measuring post-traumatic symptoms, anxiety, depression and quality of life at baseline. Two months after discharge, participants are screened for symptoms of post-traumatic stress disorder (PTSD) using the Impact of Events Scale-Revised (IES-R). Patients with IES-R scores<22 continue in an observation arm for 12 month follow-up. IES-R scores≥22 indicate above-threshold PTSD symptoms and trigger invitation to consent for part B: a randomised controlled trial (RCT) of EMDR versus usual care, with 1:1 randomisation. The study assesses feasibility (recruitment, retention and intervention fidelity) and acceptability (through semistructured interviews), using a theoretical acceptability framework. Clinical outcomes (PTSD, anxiety, depression and quality of life) are collected at baseline, 2 and 12 months, informing power calculations for a definitive RCT, with quantitative and qualitative data convergence guiding RCT refinements. ETHICS AND DISSEMINATION: This study has undergone external expert peer review and is funded by the National Institute for Health and Care Research (grant number: NIHR302160). Ethical approval has been granted by South Central-Hampshire A Research Ethics Committee (IRAS number: 317291). Results will be disseminated through the lay media, social media, peer-reviewed publication and conference presentation. TRIAL REGISTRATION NUMBER: NCT05591625.

CovEMERALD: Assessing the feasibility and preliminary effectiveness of remotely delivered Eye Movement Desensitisation and Reprocessing following Covid-19 related critical illness: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: Primary Objective: To determine the feasibility of delivering a protocolised, remote, online, Eye Movement Desensitisation and Reprocessing (EMDR) intervention, within 12-weeks of hospital discharge, for adult survivors of Covid-19 related critical illness. Secondary objectives: To investigate whether remotely delivered EMDR can improve psychological outcome following Covid-19 related critical illness, specifically Post-Traumatic Stress Disorder (PTSD), anxiety and depression. TRIAL DESIGN: This is a single centre, randomised controlled cohort feasibility trial. PARTICIPANTS: Participants will be recruited following discharge from the Intensive Care Unit at University Hospital Southampton, United Kingdom. Eligible patients will have received mechanical ventilation for a minimum of 24 hours, tested Covid-19 positive by polymerase chain reaction, will be over the age of 18 years and have the capacity to provide informed consent. Patients will be excluded if they have pre-existing cognitive impairment, pre-existing psychotic diagnosis or are not expected to survive post-hospital discharge. INTERVENTION AND COMPARATOR: Group one: patients in the control arm will receive their standard package of prescribed care, following discharge home from hospital. If they experience any adverse physical or psychological health-conditions, they will access care through the usual available channels. Group two: patients randomly allocated to the intervention arm will receive their standard package of prescribed care, following discharge home from hospital. In addition, they will be referred to the Intensive Psychological Therapies Service in Poole, United Kingdom. They will receive an online appointment within 12-weeks of discharge home from hospital. They will receive a maximum of eight, weekly sessions of EMDR, delivered by a trained psychological therapist, following the Recent Traumatic Episode Protocol (R-TEP). Appendices 1 and 2 of the attached trial protocol contain a detailed description of the R-TEP intervention, written in accordance with the Template for Intervention Description and Replication (TIDieR) checklist and guide. MAIN OUTCOMES: The primary outcome from this trial will be feasibility. Feasibility will be determined by recruitment rates, expressed as a percentage of eligible patients approached, completion of the EMDR intervention, completion of final assessment at 6-months, incidence of attributable adverse events and protocol adherence by the psychological therapists. Secondary, exploratory outcomes will be assessed by comparison between the control and intervention groups at 6-months post-hospital discharge. Psychometric evaluation will consist of the PTSD Checklist-Civilian Version and Hospital Anxiety and Depression Scale. In addition, we will assess health-related quality of life using the EQ5D-5L, physical activity using wrist worn activity monitors and nutritional state using the Council of Nutrition Appetite Questionnaire. RANDOMISATION: Consenting participants will be randomly allocated to intervention or usual care using an internet-based system (ALEATM). Participants will be randomly assigned, on a 1:1 ratio, to receive either standard care (control) or the standard care plus online EMDR R-TEP (Intervention) BLINDING (MASKING): Due to the nature of the intervention, participants cannot be blinded to group allocation. 6-month patient reported outcome measures will be completed using an online, electronic case report form. Group allocation will be masked during data analysis. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): This is a feasibility study, the results of which will be used to power a definitive study if appropriate. We anticipate a 25% mortality /loss to follow-up. A total of 26 patients will be recruited to this study, 13 patients in each arm. TRIAL STATUS: CovEMERALD opened to recruitment on 23rd September 2020 with an anticipated recruitment period of 6-months. We are using protocol version number 1.2 (1st June 2020) TRIAL REGISTRATION: CovEMERALD was registered on clinicaltrials.gov NCT04455360 on 2nd July 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).