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.

Anxiety disorders Feasibility Studies INTENSIVE & CRITICAL CARE MENTAL HEALTH PSYCHIATRY

Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
29 Jan 2024
Historique:
medline: 30 1 2024
pubmed: 30 1 2024
entrez: 29 1 2024
Statut: epublish

Résumé

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. 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. 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. NCT05591625.

Identifiants

pubmed: 38286705
pii: bmjopen-2023-081969
doi: 10.1136/bmjopen-2023-081969
doi:

Banques de données

ClinicalTrials.gov
['NCT05591625']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e081969

Informations de copyright

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

Auteurs

Andrew Bates (A)

Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK a.bates@soton.ac.uk.
Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.

Hannah Golding (H)

Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.

Sophie Rushbrook (S)

Dorset HealthCare University NHS Foundation Trust, Poole, UK.

Julie Highfield (J)

Cardiff and Vale University Health Board, Cardiff, UK.

Natalie Pattison (N)

University of Hertfordshire, Hatfield, UK.
East and North Hertfordshire NHS Trust, Stevenage, UK.

David Baldwin (D)

Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
Southern Health NHS Foundation Trust, Southampton, UK.

Michael P W Grocott (MPW)

Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.

Rebecca Cusack (R)

Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
University of Southampton Faculty of Medicine, Southampton, UK.

Classifications MeSH