[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628036":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":36,"responsibleParty":49,"collaborators":18,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":18,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":77,"overallStatus":80,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Government College University Faisalabad","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Psycho-Social Program group","EXPERIMENTAL","Participants will receive Psycho-Social Program",[13],"Behavioral: Psycho-Social Program",{"label":15,"type":16,"description":17,"interventionNames":18},"Waitlist Control Group","NO_INTERVENTION","The control group will not receive the intervention during the study period.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Psycho-Social Program","Participants in the intervention group will receive 6-8 sessions of psycho-social program (PSP) designed to improve mental health outcomes in patients with Type 2 diabetes. The session-wise agenda includes: Session 1 - Psychoeducation about diabetes and mental health; Session 2 - Behavioral Activation to increase engagement in health-promoting activities; Session 3 - Cognitive Conceptualization and Restructuring to identify and challenge negative thoughts; Session 4 - Stress Management; Session 5 - Time and Lifestyle Management; Session 6 - Problem-Solving Skills; and Session 7 - Relapse Prevention and Follow-up Planning to maintain progress and adaptive coping",[9],[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Qasir Abbas Dr Dr Qasir Abbas, PhD Clinical Psychology","CONTACT","+923337683133","+10245","qasirabbas47@yahoo.com",{"name":33,"role":28,"phone":34,"phoneExt":18,"email":35},"Sana Latif Sana Latif, PhD Applied Psychology","+923063066891","sanalateef282@gmail.com",[37],{"facility":5,"status":18,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":18},"Faisalabad","Punjab Province","38000","Pakistan","PK",{"type":44,"coordinates":45},"Point",[46,47],73.08969,31.41554,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Qasir Abbas","Tenured Associate Professor -Clinical Psychology","100628036","development-and-validation-of-psycho-social-program-psp-100628036",false,"NCT07456410","Development and Validation of Psycho-Social Program (PSP)","Development and Validation of Psycho-Social Program (PSP) for Mental Health Problems Among Patients With Type 2 Diabetes Mellitus (T2DM): A Randomised Controlled Trial","PSP-T2DM","Inclusion Criteria: Participants must be adults aged 30-40 years with Type 2 diabetes, experiencing mild-to-moderate mental health problems related to diabetes will be eligible.\n\nExclusion Criteria: Participants will be excluded if they have severe psychiatric disorders, serious medical comorbidities, are taking psychiatric medications that may affect outcomes, or are unable to participate in the intervention sessions.\n\n\\-","ALL","30 Years","40 Years",{"count":65,"type":66},80,"ESTIMATED","INTERVENTIONAL",[69],"NA","The study aims to determine the effectiveness of a structured psycho-social program (PSP) in improving mental health outcomes among patients with Type 2 diabetes mellitus (T2DM). The intervention is designed to reduce symptoms of depression, anxiety, and diabetes-related distress (DD) by addressing maladaptive thoughts, emotional responses, and coping behaviors associated with chronic illness management. Through structured sessions incorporating cognitive restructuring, stress management techniques, behavioral activation, and adaptive coping strategies, participants will learn to manage emotional distress more effectively while improving treatment adherence and daily functioning. The intervention is expected to enhance psychological well-being, promote healthier coping mechanisms, and support better overall adjustment to living with T2DM.",[72,73,74,75,76],"Mental Health Issue","Depression","Diabetes Distress","Quality of Life","Medication Adherence",[78,79],"Type 2 Diabetes Mellitus","mental health problems","NOT_YET_RECRUITING","2026-03-04",{"date":83,"type":84},"2026-03-06","ACTUAL",{"date":86,"type":66},"2026-03-25",{"date":88,"type":66},"2026-08-28",{"name":5,"class":6},1]