Anxiety Disorders, COVID, Critical Care, Depression, Intensive Care Psychiatric Disorder, Post Traumatic Stress Disorder
Conditions
Keywords
EMDR, Eye movement desensitisation and reprocessing
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.
Interventions
OTHEREye 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.
Sponsors
Dorset HealthCare University NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Patient reported outcomes at 6-months post-hospital discharge
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Cognitive function | 6 months post-hospital discharge | Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment |
| 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. |
| 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 |
| Physical activity | 6 months post-hospital discharge | Wrist worn physical activity monitoring |
| Nutritional status | 6 months post-hospital discharge | Patient generated subjective global assessment |
| Health and disability | 6 months post-hospital discharge | WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles |
Countries
United Kingdom
Outcome results
None listed