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

University Hospital Southampton NHS Foundation Trust26 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Interventions

Eye Movement Desensitisation and Reprocessing Recent traumatic Event ProtocolOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hamphsire, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

Post-Traumatic stress disorder

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