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

NCT04455360 | Completed

• 1 other identifier: Protocol version 1.2
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

EMDR; Eye movement desensitisation and reprocessing

Outcome Measures

Primary Outcomes (1)

• Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints

  Feasibility will be determined by the following measures: 1. Able to recruit \>30% of eligible patients approached 2. Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention. 3. Protocol adherence 4. Assignment of causality of serious events will be assessed by the chief investigator. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility. 5. Outcome measures completed in 75% or more of trial participants

  12 months

Secondary Outcomes (7)

• Post-Traumatic stress disorder

  6 months post-hospital discharge

• Anxiety and depression

  6 months

• Cognitive function

  6 months post-hospital discharge

• Health Related Quality of Life

  6 months post-hospital discharge

• Health and disability

  6 months post-hospital discharge

Study Arms (2)

EMDR R-TEP intervention

EXPERIMENTAL

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.

Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol

Standard care

NO INTERVENTION

Patients will receive standard post-hospital discharge care.

Interventions

Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol 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.

EMDR R-TEP intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Dorset HealthCare University NHS Foundation Trust: collaborator

Study Sites (1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hamphsire, SO16 6YD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 37744073 DERIVED

• 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.

  PMID: 33203440 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Michael P Grocott, MD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patient reported outcomes at 6-months post-hospital discharge
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 2, 2020
• Study Start: October 1, 2020
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)