Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial

NCT ID: NCT04455360

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-09-20

Brief Summary

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Primary objective is to evaluate the feasibility of delivering an online early Eye Movement Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who have survived Covid-19 related critical illness, within the context of a randomised controlled trial (RCT).

This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in reducing psychological symptoms, for adult survivors of intensive care.

Detailed Description

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A significant number of patients worldwide, have been admitted to intensive care suffering from Covid-19 related organ failure. Patients who survive a period of critical illness have a disproportionately high chance of suffering from significant and persistant poor psychological outcomes.

Eye-Movement Desensitisation and Reprocessing (EMDR) has reduced incidence of psychological morbidity in war veterans and victims of man-made and natural disasters. Small studies have also shown it to be effective in healthcare settings, within the Emergency department, following cancer diagnosis and implantation of cardioverter defibrillators. EMDR is validated by UK National Institute of Clinical Excellence guidance for use in treating adult onset PTSD.

Because of ongoing social distancing guidance our study programme aims to investigate whether it is feasible to treat patients with an early online Eye Movement Desensitisation Reprocessing (EMDR) intervention, delivered soon after hospital discharge and whether this intervention will improve psychological outcome for survivors of critical illness.

Conditions

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Post Traumatic Stress Disorder Intensive Care Psychiatric Disorder Anxiety Disorders Depression Critical Care COVID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Patient reported outcomes at 6-months post-hospital discharge

Study Groups

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EMDR R-TEP intervention

Participants will receive a minimum of 2 and a maximum of 8 online EMDR R-TEP sessions, starting within 3-months of hospital discharge. Sessions will be delivered online by experienced, suitably trained and registered psychological practitioners.

Group Type EXPERIMENTAL

Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol

Intervention Type OTHER

EMDR is a form of psychotherapy treatment whereby the client verbally relates a narrative of a traumatic episode or emotionally disturbing material in brief sequential doses while simultaneously focusing on an external stimulus. The EMDR Recent-Traumatic Events protocol (R-TEP) aims to enable an individual to process memories of the event in order to reduce psychological morbidity. EMDR R-TEP should be delivered within 3-months of the onset of a traumatic event.

Standard care

Patients will receive standard post-hospital discharge care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol

EMDR is a form of psychotherapy treatment whereby the client verbally relates a narrative of a traumatic episode or emotionally disturbing material in brief sequential doses while simultaneously focusing on an external stimulus. The EMDR Recent-Traumatic Events protocol (R-TEP) aims to enable an individual to process memories of the event in order to reduce psychological morbidity. EMDR R-TEP should be delivered within 3-months of the onset of a traumatic event.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Acute admission to Critical Care who have required mechanical ventilation for at least 24 hours
* PCR confirmed Covid-19 positive
* \>18 years of age
* Capacity to provide informed consent

Exclusion Criteria

* Acute brain injury
* Cognitive impairment
* Pre-existing psychotic diagnosis
* Not expected to survive post-hospital discharge
* Refusal to grant consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dorset HealthCare University NHS Foundation Trust

OTHER

Sponsor Role collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael P Grocott, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Southampton NHS Foundation Trust

Locations

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University Hospital Southampton NHS Foundation Trust

Southampton, Hamphsire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Bates A, Golding H, Rushbrook S, Shapiro E, Pattison N, Baldwin DS, Grocott MPW, Cusack R. A randomised pilot feasibility study of eye movement desensitisation and reprocessing recent traumatic episode protocol, to improve psychological recovery following intensive care admission for COVID-19. J Intensive Care Soc. 2023 Aug;24(3):309-319. doi: 10.1177/17511437221136828. Epub 2022 Nov 19.

Reference Type DERIVED
PMID: 37744073 (View on PubMed)

Bates A, Rushbrook S, Shapiro E, Grocott M, Cusack R. 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. Trials. 2020 Nov 17;21(1):929. doi: 10.1186/s13063-020-04805-1.

Reference Type DERIVED
PMID: 33203440 (View on PubMed)

Other Identifiers

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Protocol version 1.2

Identifier Type: -

Identifier Source: org_study_id

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