Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-31 @ 12:50 PM
Study NCT ID:
NCT04455360
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2020-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Patient reported outcomes at 6-months post-hospital discharge'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2020-06-26', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints', 'timeFrame': '12 months', 'description': 'Feasibility will be determined by the following measures:\n\n1. Able to recruit \\>30% of eligible patients approached\n2. Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention.\n3. Protocol adherence\n4. 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.\n5. Outcome measures completed in 75% or more of trial participants'}], 'secondaryOutcomes': [{'measure': 'Post-Traumatic stress disorder', 'timeFrame': '6 months post-hospital discharge', 'description': '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'}, {'measure': 'Anxiety and depression', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Cognitive function', 'timeFrame': '6 months post-hospital discharge', 'description': 'Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment'}, {'measure': 'Health Related Quality of Life', 'timeFrame': '6 months post-hospital discharge', 'description': 'EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.'}, {'measure': 'Health and disability', 'timeFrame': '6 months post-hospital discharge', 'description': 'WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles'}, {'measure': 'Physical activity', 'timeFrame': '6 months post-hospital discharge', 'description': 'Wrist worn physical activity monitoring'}, {'measure': 'Nutritional status', 'timeFrame': '6 months post-hospital discharge', 'description': 'Patient generated subjective global assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EMDR', 'Eye movement desensitisation and reprocessing'], 'conditions': ['Post Traumatic Stress Disorder', 'Intensive Care Psychiatric Disorder', 'Anxiety Disorders', 'Depression', 'Critical Care', 'COVID']}, 'referencesModule': {'references': [{'pmid': '37744073', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33203440', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nThis 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.', 'detailedDescription': '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.\n\nEye-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.\n\nBecause 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute admission to Critical Care who have required mechanical ventilation for at least 24 hours\n* PCR confirmed Covid-19 positive\n* \\>18 years of age\n* Capacity to provide informed consent\n\nExclusion Criteria:\n\n* Acute brain injury\n* Cognitive impairment\n* Pre-existing psychotic diagnosis\n* Not expected to survive post-hospital discharge\n* Refusal to grant consent'}, 'identificationModule': {'nctId': 'NCT04455360', 'acronym': 'Cov-EMERALD', 'briefTitle': 'Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Southampton NHS Foundation Trust'}, 'officialTitle': 'EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial', 'orgStudyIdInfo': {'id': 'Protocol version 1.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EMDR R-TEP intervention', 'description': '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.', 'interventionNames': ['Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Patients will receive standard post-hospital discharge care.'}], 'interventions': [{'name': 'Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['EMDR R-TEP intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hamphsire', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Michael P Grocott, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Southampton NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Southampton NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dorset HealthCare University NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}