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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

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
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.

2044-6055
Bates, Andrew
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Golding, Hannah
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Rushbrook, Sophie
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Highfield, Julie
fce223d1-1632-4ff0-b1f4-b73e91c719c9
Pattison, Natalie
0ceae0d5-e70a-401b-a0b2-074af5f49670
Baldwin, David
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Grocott, Michael P.W.
1e87b741-513e-4a22-be13-0f7bb344e8c2
Cusack, Rebecca
dfb1595f-2792-4f76-ac6d-da027cf40146
Bates, Andrew
46ff2189-9345-45bb-bb83-c90971ccccb4
Golding, Hannah
6e60b2ee-c85b-47a6-a8a8-c8996f3a0f0c
Rushbrook, Sophie
74d92021-57df-4463-b0c6-d93a6f0cfb1f
Highfield, Julie
fce223d1-1632-4ff0-b1f4-b73e91c719c9
Pattison, Natalie
0ceae0d5-e70a-401b-a0b2-074af5f49670
Baldwin, David
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Grocott, Michael P.W.
1e87b741-513e-4a22-be13-0f7bb344e8c2
Cusack, Rebecca
dfb1595f-2792-4f76-ac6d-da027cf40146

Bates, Andrew, Golding, Hannah, Rushbrook, Sophie, Highfield, Julie, Pattison, Natalie, Baldwin, David, Grocott, Michael P.W. and Cusack, Rebecca (2024) 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. BMJ Open, 14 (1), [e081969]. (doi:10.1136/bmjopen-2023-081969).

Record type: Article

Abstract

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.

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Accepted/In Press date: 28 December 2023
e-pub ahead of print date: 29 January 2024
Published date: 29 January 2024
Additional Information: © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.

Identifiers

Local EPrints ID: 490231
URI: http://eprints.soton.ac.uk/id/eprint/490231
ISSN: 2044-6055
PURE UUID: d69983b5-b35e-4d4d-b9e1-03519cf415c4
ORCID for Andrew Bates: ORCID iD orcid.org/0000-0002-3614-0270
ORCID for David Baldwin: ORCID iD orcid.org/0000-0003-3343-0907
ORCID for Michael P.W. Grocott: ORCID iD orcid.org/0000-0002-9484-7581
ORCID for Rebecca Cusack: ORCID iD orcid.org/0000-0003-2863-2870

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Date deposited: 20 May 2024 17:32
Last modified: 20 Jun 2024 02:00

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Contributors

Author: Andrew Bates ORCID iD
Author: Hannah Golding
Author: Sophie Rushbrook
Author: Julie Highfield
Author: Natalie Pattison
Author: David Baldwin ORCID iD
Author: Rebecca Cusack ORCID iD

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