Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-01-13 @ 7:41 AM
Study NCT ID:
NCT07252206
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Case Series of Culturally-adapted CBTp for Black People in the UK
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Semi-structured qualitative interview: Service user acceptability', 'timeFrame': 'End of therapy (16 weeks)', 'description': 'Service user satisfaction as assessed by qualitative interview.'}], 'secondaryOutcomes': [{'measure': 'Working Alliance Inventory-Short Form Revised', 'timeFrame': 'End of therapy (16 weeks)', 'description': 'Acceptability measured sessionally using the Working Alliance Inventory-Short Form Revised (Hatcher \\& Gillaspy, 2006)'}, {'measure': 'Adverse Events Checklist', 'timeFrame': 'Each therapy session (16 weeks)', 'description': 'Safety monitored sessionally using an Adverse Events Checklist developed for this study'}, {'measure': 'Subjective Experience of Psychosis Scale', 'timeFrame': 'End of therapy (16 weeks)', 'description': 'Subjective distress measured by the Subjective Experience of Psychosis Scale (Haddock et al., 2011)'}, {'measure': 'Questionnaire about the Process of Recovery', 'timeFrame': 'End of therapy (16 weeks)', 'description': 'Perceived recovery measured by the Questionnaire about the Process of Recovery (Law et al., 2014)'}, {'measure': 'Depression, Anxiety and Stress Scales', 'timeFrame': 'End of therapy (16 weeks)', 'description': 'Emotional wellbeing measured by the Depression, Anxiety and Stress Scales (Lovibond \\& Lovibond, 1995)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychosis', 'Schizophrenia Spectrum Disorders']}, 'descriptionModule': {'briefSummary': 'The goal of this case series study is to learn if culturally-adapted cognitive-behavioural therapy is practical, acceptable and safe among Black Sub-Saharan African and Caribbean people experiencing psychosis. The main question it aims to answer is:\n\nIs culturally-adapted CBT for psychosis feasible, acceptable to and safe for Black Sub-Saharan African and Caribbean people experiencing psychosis?\n\nParticipants will be asked to:\n\n* Answer some questionnaires about how things are at the moment\n* Attend up to 16 sessions of therapy\n* Answer the same questionnaires to see what has changed, if anything\n* Complete a semi-structured interview about their expectations and experience of therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Service users who identify as Black British, Black Caribbean, Black African, African-Caribbean or Mixed African/Caribbean with at least one parent and/or grandparent born in a Sub-Saharan African or Caribbean country\n* People with a current ICD-10 schizophrenia spectrum disorder diagnosis, or who are currently receiving or have received support from an Early Intervention in Psychosis team\n* 16 years or older\n* Sufficient understanding of English to complete study measures and engage with CBTp\n\nExclusion Criteria:\n\n* Current, primary diagnosis of substance use disorder\n* Organic aetiology of psychosis\n* Lacking capacity to provide full informed consent\n* Currently experiencing a mental health crisis (i.e., are open to a home-based treatment teamÍž are currently under Section of the Mental Health Act or have been under Section in the past 3 months) or immediate high risk to self or others (i.e., current suicidal intent or plansÍž unmanaged and intense non-suicidal self-injury)\n* Currently receiving CBTp or received CBTp within the preceding 3 months\n* Unwilling to participate in culturally-adapted CBTp'}, 'identificationModule': {'nctId': 'NCT07252206', 'briefTitle': 'A Case Series of Culturally-adapted CBTp for Black People in the UK', 'organization': {'class': 'OTHER', 'fullName': 'University of Manchester'}, 'officialTitle': 'Culturally-adapted Cognitive-behavioural Therapy for Black Sub-Saharan African and Caribbean People Experiencing Psychosis: A Case Series', 'orgStudyIdInfo': {'id': 'NHS002287'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapy', 'interventionNames': ['Behavioral: Culturally-adapted cognitive-behavioural therapy']}], 'interventions': [{'name': 'Culturally-adapted cognitive-behavioural therapy', 'type': 'BEHAVIORAL', 'description': 'Cognitive-behavioural therapy for psychosis culturally-adapted for Black Sub-Saharan African and Caribbean people using a dedicated, integrated treatment manual', 'armGroupLabels': ['Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Greater Manchester Mental Health NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Peter Panayi', 'role': 'CONTACT', 'email': 'peter.panayi@manchester.ac.uk', 'phone': '+44161 306 6000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manchester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peter Panayi', 'investigatorAffiliation': 'University of Manchester'}}}}