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Completed

NCT Number: NCT04455360

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

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.

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Key information

Conditions

Post Traumatic Stress Disorder Anxiety Disorders Behavior Behavioral Symptoms COVID Critical Care Depression Intensive Care Psychiatric Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Southampton NHS Foundation Trust

Southampton, Hamphsire, SO16 6YD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 12 months

    Feasibility will be determined by the following measures:

    • Able to recruit >30% of eligible patients approached
    • Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention.
    • Protocol adherence
    • 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.
    • Outcome measures completed in 75% or more of trial participants

Secondary outcomes

  1. Post-Traumatic stress disorder

    Time frame: 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

  2. Anxiety and depression

    Time frame: 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

  3. Cognitive function

    Time frame: 6 months post-hospital discharge

    Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment

  4. Health Related Quality of Life

    Time frame: 6 months post-hospital discharge

    EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.

  5. Health and disability

    Time frame: 6 months post-hospital discharge

    WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles

  6. Physical activity

    Time frame: 6 months post-hospital discharge

    Wrist worn physical activity monitoring

  7. Nutritional status

    Time frame: 6 months post-hospital discharge

    Patient generated subjective global assessment

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Collaborators

  • Dorset HealthCare University NHS Foundation Trust

Registry information

Official study title

EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial

Acronym: Cov-EMERALD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2020
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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