Post Traumatic Stress DisorderCov-EMERALDNCT04455360
Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial
A study testing Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol in people with Post Traumatic Stress Disorder and Intensive Care Psychiatric Disorder, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, Intensive Care Psychiatric Disorder, Anxiety Disorders
- What is being tested?
- Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2020to 20 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute brain injury
- Cognitive impairment
- Pre-existing psychotic diagnosis
- Not expected to survive post-hospital discharge
- Refusal to grant consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton NHS Foundation Trust
Southampton, Hamphsire, SO16 6YD
About this study
Official title: EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related 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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder, Intensive Care Psychiatric Disorder, Anxiety Disorders, Depression, Critical Care, COVID
- Being tested
- Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol
- Keywords
- EMDR, Eye movement desensitisation and reprocessing
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol |
| Standard care | No intervention | Patients will receive standard post-hospital discharge care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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
Measured: 12 months
Secondary outcomes (7)
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
Measured: 6 months post-hospital discharge
Anxiety and depression
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
Measured: 6 months
Cognitive function
Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment
Measured: 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.
Measured: 6 months post-hospital discharge
Health and disability
WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles
Measured: 6 months post-hospital discharge
Physical activity
Wrist worn physical activity monitoring
Measured: 6 months post-hospital discharge
Nutritional status
Patient generated subjective global assessment
Measured: 6 months post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Oct 2020
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Dorset HealthCare University NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Michael P Grocott, MD, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455360
- Sponsor's protocol ID
- Protocol version 1.2
- Acronym
- Cov-EMERALD
- Status last verified
- Sep 2021
- First submitted
- 26 Jun 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37744073Bates 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.
PubMed 33203440
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT04455360
- Acronym / sponsor ID
- Cov-EMERALD / Protocol version 1.2
- Conditions
- Post Traumatic Stress Disorder, Intensive Care Psychiatric Disorder, Anxiety Disorders, Depression, Critical Care, COVID
- Keywords
- EMDR, Eye movement desensitisation and reprocessing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Dorset HealthCare University NHS Foundation Trust
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMDR R-TEP intervention | Experimental | Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event ProtocolParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Acute brain injury
- Cognitive impairment
- Pre-existing psychotic diagnosis
- Not expected to survive post-hospital discharge
- Refusal to grant consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Movement Desensitisation and Reprocessing Recent traumatic Event ProtocolEMDR 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. | Other | EMDR R-TEP intervention |
Primary outcome
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: 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
7 secondary outcomes
Post-Traumatic stress disorder
Time frame: 6 months post-hospital discharge
Anxiety and depression
Time frame: 6 months
Cognitive function
Time frame: 6 months post-hospital discharge
Health Related Quality of Life
Time frame: 6 months post-hospital discharge
Health and disability
Time frame: 6 months post-hospital discharge
Physical activity
Time frame: 6 months post-hospital discharge
Nutritional status
Time frame: 6 months post-hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 37744073Bates 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.
- Derived from this study: PubMed 33203440Bates 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Grocott, MD principal investigator
University Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol in people with Post Traumatic Stress Disorder and Intensive Care Psychiatric Disorder, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04455360, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.