Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-30 @ 2:54 PM
Study NCT ID:
NCT06618404
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2021-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UK Prevalence of Mental Health After SCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-23', 'size': 7431630, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-10-19T07:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2024-09-25', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': 'Baseline', 'description': 'Generalised Anxiety Disorder Scale (GAD-7); minimum score = 0; maximum score = 21; Scores higher than 15 represent severe clinical levels of anxiety.'}, {'measure': 'Depression', 'timeFrame': 'Baseline', 'description': 'Patient Health Questionnaire-9 (PHQ-9); minimum score = 0; maximum = 27; scores over 20 represent severe clinical depression.'}, {'measure': 'Post-traumatic Stress Disorder', 'timeFrame': 'Baseline', 'description': 'Impact of Event Scale-Revised (IES-R); 22 item measure of PTSD; minimum score = 0; maximum score = 88; scores over 33 indicate the clinical cut-off for probable PTSD.'}], 'secondaryOutcomes': [{'measure': 'Pain Interference', 'timeFrame': 'Baseline', 'description': 'Multi-dimensional Pain Inventory: Spinal Cord Injury (MPI-SCI) Life Interference Subscale; Minimum interference score = 0; maximum interference score = 120; high scores indicate more problematic interference of pain with life.'}, {'measure': 'Coping Self-efficacy', 'timeFrame': 'Baseline', 'description': 'Coping Self-efficacy scale (CSES); minimum score = 0; maximum score = 50 (the mean for each of the five subscales is then summed).'}, {'measure': 'Resilience', 'timeFrame': 'Baseline', 'description': 'Connor-Davison Resilience Scale-10 (CD-RISC-10); minimum score = 0; maximum score = 100; higher scores indicate greater resilience.'}, {'measure': 'Life Satisfaction', 'timeFrame': 'Baseline', 'description': 'Satisfaction with Life Scale (SWLS); minimum score = 5; maximum score = 35, with higher scores indicating greater satisfaction with life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resilience', 'Mental health', 'Adjustment', 'Chronic pain'], 'conditions': ['Spinal Cord Injuries', 'Anxiety Disorders', 'Depression', 'PTSD', 'Pain']}, 'descriptionModule': {'briefSummary': 'Mental health decline after Spinal Cord Injury (SCI) is commonly reported but minimally investigated in the United Kingdom. The current study aims to explore the prevalence and impact of mental health challenges after SCI to establish population norms in the UK. Additionally the current study will aim to identify barriers to and facilitators of mental health support seeking in people with SCI.', 'detailedDescription': "A four-phase mixed methods research study will be undertaken. Phase One will be a cross-sectional online survey designed to determine the prevalence of mental health conditions in adults with SCI in the UK assessing resilience, anxiety, depression, pain, life satisfaction, PTSD and coping self-efficacy.\n\nPhase Two will consist of in-depth semi-structured online interviews conducted with approximately twenty people with Spinal Cord Injury who, in the first study, indicated either that the participants had accessed, or had wanted to access mental health services. The two-part interview schedule will be undertaken, covering: 1) core themes surrounding the causes of, changes in, and management of mental health after SCI; and 2) questions relating to participant hopes for and experiences of satisfaction with, access to and efficacy of mental health services, in the context of the mental health service providers which participants currently use or have attempted to access.\n\nPhase Three will consist of in-depth semi-structured online interviews held with approximately twenty 'significant others' (partner/family/friend) of people with Spinal Cord Injury whose family member/partner/friend experience mental health problems. The interview schedule will cover two core themes surrounding: 1) perceptions of the causes and impact of mental health difficulties after SCI on 'significant others'; 2) their experiences of current mental health services provided for participants' partner/family/friend and perceived recommendations and hopes for better management of mental health in participants' family member/partner.\n\nPhase Four will recruit twenty-five people with high resilience (\\>30 on the CD-RISC-10) to participate in an in-depth semi-structured online interview. This will review participants' thoughts and perceptions about resilience and how it is possible to maintain a high level of resilience whilst living with spinal cord injury."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adults with spinal cord injury (Phases 1, 2 and 4) or their 'significant others' (Phase 3)", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Phases 1 and 2 (survey and SCI interviews)\n\n* Adults with spinal cord injury\n* Adults with cauda equina syndrome\n\nExclusion Criteria:\n\n* Difficulty with written or verbal English Language comprehension\n\nInclusion Criteria: Phase 3\n\n\\- Partner, Spouse, Family member or carer of a person with Spinal Cord Injury\n\nExclusion criteria:\n\n\\- Difficulty with verbal English Language comprehension\n\nInclusion Criteria: Phase 4\n\n\\- Adults with Spinal Cord Injury who screen as having resilience higher than 30 on the Connor-Davidson Resilience Scale (CDRS-10).\n\nExclusion Criteria: Phase 4\n\n* Adults with Spinal Cord Injury with resilience lower than 30\n* Adults with Spinal Cord Injury who choose not to complete the CDRS-10.'}, 'identificationModule': {'nctId': 'NCT06618404', 'briefTitle': 'UK Prevalence of Mental Health After SCI', 'organization': {'class': 'OTHER', 'fullName': 'University of Reading'}, 'officialTitle': 'Establishing the Mental Health Needs of People With Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'MHSCI'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention - cross-sectional cohort analysis', 'type': 'OTHER', 'description': 'Observational'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG6 7BE', 'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'facility': 'University of Reading', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}]}, 'ipdSharingStatementModule': {'url': 'https://odc-sci.org', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'From January 2022, indefinitely', 'ipdSharing': 'YES', 'description': 'Anonymised data from the survey will be shared using https://odc-sci.org', 'accessCriteria': 'ODC-SCI membership'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Reading', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spinal Injuries Association', 'class': 'UNKNOWN'}, {'name': 'University of Buckingham', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Katherine Finlay, Lecturer in Psychology', 'investigatorFullName': 'Katherine Finlay', 'investigatorAffiliation': 'University of Reading'}}}}