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| Name | Class |
|---|---|
| Dorset HealthCare University NHS Foundation Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard care | No Intervention | Patients will receive standard post-hospital discharge care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months post-hospital discharge |
| Anxiety and depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Grocott, MD | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Southampton NHS Foundation Trust | Southampton | Hamphsire | SO16 6YD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37744073 | Derived | 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. | |
| 33203440 |
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Patient reported outcomes at 6-months post-hospital discharge
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|
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 |
| 6 months |
| Cognitive function | Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment | 6 months post-hospital discharge |
| Health Related Quality of Life | EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression. | 6 months post-hospital discharge |
| Health and disability | WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles | 6 months post-hospital discharge |
| Physical activity | Wrist worn physical activity monitoring | 6 months post-hospital discharge |
| Nutritional status | Patient generated subjective global assessment | 6 months post-hospital discharge |
| 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. |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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