[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660444":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":33,"interventions":44,"overallOfficials":50,"centralContacts":55,"locations":61,"responsibleParty":75,"collaborators":25,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":25,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":25,"overallStatus":101,"whyStopped":25,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Biruni University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":25},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Change in Internalized Stigma of Mental Illness Scale (ISMI) Score","Internalized stigma will be assessed using the Internalized Stigma of Mental Illness Scale (ISMI). The scale consists of 29 items rated on a 4-point Likert scale. Total scores range from 29 to 116, with higher scores indicating higher levels of internalized stigma.","Baseline and immediately after the 7-week intervention.",{"measure":14,"description":15,"timeFrame":12},"Change in General Self-Efficacy Scale Score","Self-efficacy will be assessed using the 17-item General Self-Efficacy Scale. Total scores range from 17 to 85, with higher scores indicating greater self-efficacy.",{"measure":17,"description":18,"timeFrame":12},"Change in Personal and Social Performance Scale (PSP) Score","Personal and social functioning will be assessed using the Personal and Social Performance Scale. The overall score ranges from 1 to 100, with higher scores indicating better personal and social functioning.",{"measure":20,"description":21,"timeFrame":12},"Change in Canadian Occupational Performance Measure (COPM) Scores","Occupational performance will be assessed using the Canadian Occupational Performance Measure (COPM). Participants identify and prioritize occupational performance problems and rate their perceived performance on a 10-point scale, with higher scores indicating better perceived occupational performance. Change in occupational performance from baseline to post-intervention will be evaluated.",{"measure":23,"description":24,"timeFrame":12},"Change in Lawton-Brody Instrumental Activities of Daily Living (IADL) Score","Independence in instrumental activities of daily living will be assessed using the Lawton-Brody Instrumental Activities of Daily Living Scale. Total scores range from 0 to 8, with higher scores indicating greater independence.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of two parallel groups: an intervention group receiving a seven-session occupational therapy group intervention in addition to routine Community Mental Health Center services, or a control group receiving routine Community Mental Health Center services only. Outcomes will be assessed at baseline and after the seven-week intervention period.","TREATMENT",{"masking":32,"maskingDescription":25,"whoMasked":25},"NONE",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"Occupational Therapy Intervention Group","EXPERIMENTAL","Participants in this group will receive a structured seven-session occupational therapy group intervention in addition to routine Community Mental Health Center services. Sessions will be delivered once weekly for 60-90 minutes over seven weeks.",[39],"Behavioral: Occupational Therapy Group Intervention",{"label":41,"type":42,"description":43,"interventionNames":25},"Control Group","NO_INTERVENTION","Participants in this group will continue to receive routine Community Mental Health Center services and will not receive any additional occupational therapy intervention during the seven-week study period.",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":25},"BEHAVIORAL","Occupational Therapy Group Intervention","A structured occupational therapy group intervention consisting of seven weekly sessions, each lasting approximately 60-90 minutes. The program addresses self-awareness and identity, internalized stigma, personal strengths and self-efficacy, daily life roles, role performance, goal setting, and social participation through structured group activities and psychoeducational components.",[35],[51],{"name":52,"affiliation":53,"role":54},"Eylül Pınar Kısa, PhD","Medipol University","PRINCIPAL_INVESTIGATOR",[56],{"name":57,"role":58,"phone":59,"phoneExt":25,"email":60},"Şüheda Keleş Özen, BSc","CONTACT","+90 545 554 09 18","suheda.keles@std.medipol.edu.tr",[62],{"facility":63,"status":25,"city":64,"state":64,"zip":65,"country":66,"countryCode":25,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Çekmeköy Toplum Ruh Sağlığı Merkezi","Istanbul","34782","Turkey (Türkiye)",{"type":68,"coordinates":69},"Point",[70,71],28.94966,41.01384,{"lat":71,"lon":70},[74],{"name":57,"role":58,"phone":59,"phoneExt":25,"email":60},{"type":76,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100660444","effect-of-occupational-therapy-on-psychosocial-parameters-and-functioning-in-individuals-with-severe-mental-illness-100660444",false,"NCT07879118","Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness","The Effect of Occupational Therapy Intervention on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness","OT-SMI","Inclusion Criteria:\n\n* Registered at the Community Mental Health Center (CMHC).\n* Diagnosis of schizophrenia, schizoaffective disorder, non-organic psychosis, or bipolar disorder according to DSM-5 criteria, confirmed by the psychiatrist responsible for the CMHC.\n* Aged between 18 and 65 years.\n* In remission, as confirmed by the psychiatrist responsible for the CMHC.\n* Able to read and write.\n* Willing to participate in the study and provide informed consent.\n\nExclusion Criteria:\n\n* Being in an acute psychotic exacerbation.\n* Presence of a severe neurological disorder or a medical condition that would prevent participation in the intervention.\n* Presence of cognitive impairment or intellectual disability that would prevent participation in the study.\n* Presence of language or speech problems that would prevent participation in the study.","ALL","18 Years","65 Years",{"count":89,"type":90},50,"ESTIMATED","INTERVENTIONAL",[93],"NA","Severe mental illness (SMI), including schizophrenia spectrum disorders and bipolar disorder, is associated with significant impairments in psychosocial functioning, daily life participation, self-efficacy, and social functioning. Despite pharmacological treatment, many individuals continue to experience limitations in social relationships, occupational roles, independent living activities, and overall functioning. Psychosocial rehabilitation interventions are therefore important components of comprehensive mental health care.\n\nOccupational therapy aims to improve individuals' participation in meaningful daily activities, enhance occupational performance, strengthen social roles, and support recovery. However, evidence regarding the effects of occupational therapy interventions on internalized stigma, self-efficacy, and personal and social functioning among individuals with SMI remains limited.\n\nThis randomized controlled trial aims to investigate the effects of a structured occupational therapy group intervention on internalized stigma, self-efficacy, personal and social functioning, occupational performance, and instrumental activities of daily living in individuals with SMI receiving services at a Community Mental Health Center. Eligible participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in a seven-session occupational therapy group program, with one 60-90-minute session per week, while the control group will continue to receive routine Community Mental Health Center services.\n\nThe intervention addresses self-awareness and identity, internalized stigma, personal strengths and self-efficacy, daily life roles, role performance, goal setting, and social participation through structured group activities and psychoeducational components. Outcomes will be assessed before the intervention and after the seven-week intervention period using validated measures of internalized stigma, self-efficacy, personal and social functioning, occupational performance and satisfaction, and instrumental activities of daily living.\n\nIt is hypothesized that participants receiving the occupational therapy intervention will demonstrate reduced internalized stigma and improved self-efficacy and personal and social functioning compared with participants receiving routine services alone.",[96,97,98,99,100],"Schizophenia Disorder","Severe Mental Illness","Bipolar Disorder","Nonorganic Psychosis","Schizo-affective Disorder","NOT_YET_RECRUITING","2026-10-13",{"date":104,"type":105},"2026-10-16","ACTUAL",{"date":107,"type":90},"2026-10",{"date":109,"type":90},"2026-12",{"name":5,"class":6},1]