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

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder; Anxiety Disorders; Intensive Care Psychiatric Disorder; COVID; Depression; Critical Care
• Interventions: Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol

• Registration Number: NCT04455360
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-02
• Study Start: 2020-10-01
• Status Verified: 2021-09
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMDR R-TEP intervention	Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints	12 months	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

Secondary Outcome Measures

Name	Time	Method
Post-Traumatic stress disorder	6 months post-hospital discharge	The PTSD Checklist-Civilian Version (PCL-C) is a validated, standardised self-reporting questionnaire for PTSD comprising of 17 items that correspond to key PTSD symptoms
Nutritional status	6 months post-hospital discharge	Patient generated subjective global assessment
Cognitive function	6 months post-hospital discharge	Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment
Anxiety and depression	6 months	Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-reported measure with 7-items relating to symptoms of anxiety and 7-items relating to depression
Health Related Quality of Life	6 months post-hospital discharge	EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.
Health and disability	6 months post-hospital discharge	WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles
Physical activity	6 months post-hospital discharge	Wrist worn physical activity monitoring

Trial Locations

Locations (1)

University Hospital Southampton NHS Foundation Trust; 🇬🇧 Southampton, Hamphsire, United Kingdom