[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565801":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":24,"studyPopulation":16,"armGroups":25,"interventions":35,"overallOfficials":16,"centralContacts":16,"locations":45,"responsibleParty":68,"collaborators":16,"id":70,"slug":16,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":16,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":16,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":16,"overallStatus":47,"whyStopped":16,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Pakistan Association of Cognitive Therapists","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Feasibility and acceptability measures","Feasibility and acceptability and Client's satisfaction will be measured through standardized measures of anxiety and depression","12 weeks",{"measure":14,"description":15,"timeFrame":12},"Clinical Measures","Depression and Anxiety, measured by Hosptal and Anxiety Scale (HADS)",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":20,"primaryPurpose":21,"observationalModel":16,"timePerspective":16,"maskingInfo":22},"RANDOMIZED","PARALLEL","This will be a randomized controlled trial to evaluate the feasibility and acceptability of delivering a new intervention. Participants who meet the inclusion criteria will be randomly allocated to intervention or control groups in a 1:1 ratio.","HEALTH_SERVICES_RESEARCH",{"masking":23,"maskingDescription":16,"whoMasked":16},"NONE","Randomized Controlled Trial (RCT): Participants will be randomly assigned to either the culturally adapted CBT manual group or the standard CBT manual group. A culturally adapted manual will integrate cultural values, norms, and idioms of suffering into CBT techniques, ensuring relevance and acceptance within the target cultural group. The standard CBT manual will follow conventional CBT techniques without specific cultural adaptations.",[26,31],{"label":27,"type":28,"description":16,"interventionNames":29},"culturally adapted CaCBT manual","EXPERIMENTAL",[30],"Behavioral: Culturally adapted CBT (CaCBT) based guided self-help manual",{"label":32,"type":28,"description":16,"interventionNames":33},"standard CBT manual",[34],"Behavioral: Standard CBT Manual",[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":16},"BEHAVIORAL","Culturally adapted CBT (CaCBT) based guided self-help manual","The intervention consists of seven modules including cognitive restructuring, problem solving, behavioural activation and conflict management. Three additional modules focus on interpersonal relationships, mental health wellbeing and self-care. Each module is delivered over one week. The intervention uses culturally appropriate stories, drawings, examples from local folklore and religious context to describe the concepts of CBT.",[27],{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":16},"Standard CBT Manual","The standard CBT manual will follow conventional CBT techniques without specific cultural adaptations",[32],[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Lahore","Punjab Province","54000","Pakistan","PK",{"type":54,"coordinates":55},"Point",[56,57],74.35071,31.558,{"lat":57,"lon":56},[60,65],{"name":61,"role":62,"phone":63,"phoneExt":16,"email":64},"Taj Magsi","CONTACT","00923233914614","tajmagsi2017@gmail.com",{"name":66,"role":67,"phone":16,"phoneExt":16,"email":16},"Farooq Naeem","PRINCIPAL_INVESTIGATOR",{"type":69,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100565801",false,"NCT06646900","Feasibility and Acceptability Trial of a Culturally Adapted Manual Versus Standard CBT Manual: A Randomized Control Trial","Inclusion Criteria:\n\n1. Individuals aged 18 to 65 years\n2. 5 years of education\n3. Symptoms of depression and anxiety\n\nExclusion Criteria:\n\n1. Substance use disorder according to DSM-5 criteria as determined by primary care clinician\n2. Significant cognitive impairment (for example, profound learning disability or dementia) as determined by primary care clinician\n3. Active psychosis as determined by their primary care clinician","ALL","18 Years","65 Years",{"count":79,"type":80},200,"ESTIMATED","INTERVENTIONAL",[83],"NA","This randomized controlled trial (RCT) will compare the efficacy and feasibility and acceptability of a culturally adapted CBT manual with a standard CBT manual, focusing on addressing cultural factors in therapy delivery.",[86,87],"Anxiety","Depression","2024-10-16",{"date":90,"type":91},"2024-10-17","ACTUAL",{"date":93,"type":80},"2024-11-20",{"date":95,"type":80},"2024-12-31",{"name":5,"class":6},1]