[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501873":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":33,"centralContacts":40,"locations":46,"responsibleParty":66,"collaborators":68,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":23,"enrollmentInfo":81,"targetDuration":23,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":49,"whyStopped":23,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Pakistan Institute of Living and Learning","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"CaCBT for psychosis","EXPERIMENTAL","CaCBT is a culturally adapted psychosocial intervention for people with early psychosis that comprises of 12 sessions. These sessions are conducted individually on a weekly basis and last 45-60 minutes",[13],"Behavioral: CaCBT for psychosis",{"label":15,"type":10,"description":16,"interventionNames":17},"CulFI Intervention","CulFI is a culturally adapted psychosocial intervention delivered over 10 sessions of 40-60 minutes, weekly for the first 8 weeks and fortnightly for the remaining 4 weeks. Sessions are delivered to patients and their carers, though patient participation in sessions is not necessary.",[18],"Behavioral: Culturally adapted Family Intervention (CulFI) for psychosis",{"label":20,"type":21,"description":22,"interventionNames":23},"Treatment as Usual (TAU)","NO_INTERVENTION","TAU will be ascertained by the participant's treating physician. Research staff will record the nature and intensity of TAU delivered to each participant over a period of 3 months.",null,[25,29],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":23},"BEHAVIORAL","The CaCBT intervention is based on the intervention manual developed by David Kingdon and Douglas Turkington, and culturally adapted by our group. CaCBT aims to take a collaborative approach to gaining an understanding of the symptoms",[9],{"type":26,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"Culturally adapted Family Intervention (CulFI) for psychosis","CulFI intervention comprises of Family psychoeducation; cognitive-behavioural skills training for stress-management, coping and problem solving; crisis intervention and suicide risk management; relapse prevention; education and support regarding the family environment, including communication training. The components are designed to facilitate an understanding about psychosis, the emotional impact of the illness on family relationships, to promote more adaptive coping strategies and minimize relapse risk.",[15],[34,38],{"name":35,"affiliation":36,"role":37},"Omair Husain, MD","Centre for Addiction and Mental Health","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":37},"Imran B Chaudhry, MD",[41],{"name":42,"role":43,"phone":44,"phoneExt":23,"email":45},"Ameer B Khoso","CONTACT","021-35371084","ameer.bukhsh@pill.org.pk",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Civil hospital","RECRUITING","Karachi","Sindh","75600","Pakistan","PK",{"type":56,"coordinates":57},"Point",[58,59],67.0104,24.8608,{"lat":59,"lon":58},[62],{"name":63,"role":43,"phone":64,"phoneExt":23,"email":65},"Tayyeba Kiran","0923328262142","tayyebakiran@gmail.com",{"type":67,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[69],{"name":36,"class":6},"100501873","culturally-adapted-psychosocial-interventions-for-early-psychosis-in-a-low-resource-setting-100501873",false,"NCT05814913","Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting","Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting: a Large Multi-center Randomised Controlled Trial","CaPSI","Inclusion Criteria for patient participants:\n\n* Individuals of all genders aged over 18 years; diagnosis of schizophrenia confirmed by Structured Clinical Interview for DSM (SCID) meeting DSM-5 criteria for schizophrenia, schizophreniform or schizoaffective psychosis\n* Scored at least 4 on the PANSS delusions or hallucinations items, or at least 5 on suspiciousness, persecution, or grandiosity items\n* stable on medication for the past four weeks\n* in contact with mental health services\n* within 3 years of diagnosis\n* able to demonstrate the capacity to provide informed consent to take part in the study\n* potential participants must have a carer or relative who is also willing to participate in the study to be eligible\n\nExclusion Criteria for patient participants:\n\n* Active DSM-5 substance use disorder (except nicotine or caffeine) or dependence within the last three months\n* A score of 5 or more on the PANSS conceptual disorganisation item\n* Individuals who have received structured psychological intervention within the past 3 months\n* Relevant CNS or other medical disorders that would impact participation\n* Diagnosis of intellectual disability\n* Unstable residential arrangements\n\nFamily member\u002FCarer participant inclusion criteria:\n\n* Living with or spending at least 10 hours per week in face-to-face contact with an individual with early psychosis and assuming a caring role\n* Age\\>18 years\n* Able to give informed written consent.\n\nFamily member\u002FCarer participant exclusion criteria:\n\n* Active DSM-5 substance use disorder\n* Received psychological intervention within the past 3 months\n* Unstable residential arrangements.",true,"ALL","18 Years",{"count":82,"type":83},390,"ESTIMATED","INTERVENTIONAL",[86],"NA","Primary Aims:\n\nTo determine the clinical efficacy of Culturally adapted Cognitive Behavioral Therapy (CaCBT) and Culturally adapted Family Intervention (CulFI) compared to Treatment As Usual (TAU) on reducing overall symptoms of psychosis in patients with First Episode Psychosis (FEP) in Pakistan.\n\nSecondary Aims:\n\n1. To determine the efficacy of CaCBT and CulFI compared to TAU on positive and negative symptoms of psychosis, general psychopathology, depressive symptoms, quality of life, general functioning, and insight in patients with FEP in Pakistan.\n2. To determine the efficacy of CaCBT and CulFI compared to TAU on improving carer experience, carer wellbeing, carer illness attitudes and symptoms of depression and anxiety in family and carers of patients with FEP in Pakistan.\n3. To determine the comparative effect of CaCBT and CulFI in improving patient and carer related outcomes in individuals with FEP in Pakistan.\n4. To estimate the economic impact of delivering culturally appropriate psychosocial interventions in low-resource settings\n5. To explore delivery and reach of each intervention, tolerability of intervention components, acceptability of interventions, understanding mechanism of change and developing an understanding of barriers and facilitators to future adoption using process evaluation.\n\nStudy design and setting:\n\nThis will be a multi-centre, assessor masked, individual, three-arm randomised controlled trial (RCT).\n\nSample Size:\n\nThe study aims to recruit a total of N=390 participants with FEP",[89],"Psychosis",[91,92,93,94,95],"First Episode Psychosis","LAMIC","Family Intervention","CBT","Paksitan","2024-12-07",{"date":98,"type":99},"2024-12-12","ACTUAL",{"date":101,"type":99},"2024-04-15",{"date":103,"type":83},"2026-12-31",{"name":5,"class":6},1]