[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06782321":3,"trial-entities:NCT06782321":139,"trial-summary:NCT06782321":142},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":15,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":73,"locations":76,"central_contacts":91,"overall_officials":96,"references":105,"see_also_links":138},"NCT06782321","Pro00138136","Emotional Recovery Post-Stroke","Centering Emotional Recovery Post-Stroke","RECRUITING","2027-12","2026-06","2026-06-18","2025-05-01","Medical University of South Carolina","OTHER",null,"The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and\u002For speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke.","The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and\u002For speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke. Participants will complete 9 telerehabilitation therapy sessions over 8 weeks. These sessions will take place over a video visit using a personal device (phone, tablet, or computer). Each session will last about 1 hour. Sessions will focus on occupational therapy and\u002For speech therapy depending on the participant's stroke-related movement and\u002For language deficits. Each study participant will be randomly assigned to one of two intervention groups. Both groups will include OT or ST; however, one group will include an emotional wellness component using a modified version of Cognitive Behavioral Therapy. Participants will also complete 2 assessment visits, one before the telerehabilitation begins and one after the telerehabilitation program ends. The assessment visits will also take place via a video visit using a personal device. Assessments include measures of emotional well-being, quality of life, activity engagement, arm\u002Fhand movement, communication\u002Flanguage skills, balance, and ability to perform daily activities.",[19,20],"Stroke","Mental Health Wellness 1",[22,19,23],"Rehabilitation Studies","Stroke Recovery","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},80,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","modified Cognitive Behavioral Therapy (mCBT)","The theoretical model underling Cognitive Behavioral Therapy (CBT) explains the interaction of thoughts, feelings, and behaviors during life situations. This model suggests that a person's thoughts\u002Ffeeling\u002Fbehaviors affect their functioning during life situations. This contrasts with a common belief that one's functioning during life situations is the only way to effect thoughts\u002Ffeelings\u002Fbehaviors. Applied to stroke, this model suggests that the stroke survivor can alter his\u002Fher functioning during life situations by altering his\u002Fher thoughts\u002Ffeelings\u002Fbehaviors. The purpose of CBT is to empower the person with the skills to alter his\u002Fher thoughts\u002Ffeelings\u002Fbehaviors in order to positively affect function in life situations.\n\nThe mCBT intervention includes 4 elements: psychoeducation, education about unhelpful thinking, behavioral activation therapy, education on sleep hygiene, and relaxation training.",[37],"modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech Therapy",{"type":33,"name":39,"description":40,"armGroupLabels":41},"Occupational or Speech Therapy","If the participant demonstrates aphasia of any severity level on the Revised Western Aphasia Battery (WAB-R) assessment given at the PRE session, the subject will receive ST, provided by a Speech Language Pathologists (SLP), stroke telerehabilitation. If there is no aphasia, the subject will receive OT stroke telerehabilitation.\n\nThe OT and ST stroke telerehabilitation sessions will utilize a similar metacognitive strategy training approach which is focused on enabling the stroke survivor to re-engage with meaningful life activities. In the Occupational Therapy literature this approach is called Cognitive Orientation to Occupational Performance (CO-OP) and in the Speech Language Pathology Literature this approach is called the Life Participation Approach to Aphasia (LPAA).\n\nTelerehabilitation CO-OP and LPAA within the OT or ST session include three common elements: Shared decision-making for goal setting, guidance\u002Fcoaching from the therapist, and self-evaluation.",[42,37],"Telerehabilitation Occupational or Speech Therapy",[44,48,51],{"measure":45,"description":46,"timeFrame":47},"Warwick-Edinburgh Mental Wellbeing Scale (WEMWS)","14-item scale of mental well-being rated by participants on a 5-point scale (1=low, 5=high). Summed item ratings are reported out of 70 points so that higher scores indicate greater mental wellbeing.","Baseline, pre-intervention and immediately after the intervention, Week 8.",{"measure":49,"description":50,"timeFrame":47},"Patient Specific Functional Scale (PSFS)","A patient-reported measure of task-goal identification and difficulty performing the task on a 0-10-point ordinal scale with higher ratings indicating greater satisfaction with task performance.",{"measure":52,"description":53,"timeFrame":47},"Stroke and Aphasia Quality of Life Scale (SAQoL)","39-item stroke-specific measure of health-related quality of life rated by participants on a 5-point scale (1 = couldn't do it at all, 5 = no trouble at all). An overall mean score is computed as well as three domain scores: physical, communication, and psychosocial. Higher scores indicate better quality of life.",[],"ALL","21 Years",false,{"inclusion":59,"exclusion":68,"raw_text":72},[60,61,62,63,64,65,66,67],"Self-reported stroke-related deficits in emotional wellness such as anxiety, sleep disturbance, dread, fear, loss of hope, sadness.","Have experienced ischemic or hemorrhagic stroke at least 30 days prior","Stroke-related aphasia and\u002For upper extremity hemiparesis","Aged 21 years or older","English as primary language","Have corrected vision to be able to read text on a screen","Able to participate fully in the study's tele-rehabilitation (Aim 1) and\u002For virtual group programing (Aim 2) with personally owned device (i.e., phone, tablet, or laptop) and personal Wi-Fi connection or cellular service","Cognitive, language, and motor capacity to participate fully in the study's assessment session as per the judgment of the licensed, experienced stroke tele-rehabilitation occupational or speech therapist",[69,70,71],"Unable to follow 1-2 step instructions given by the study team member during the informed consent procedures.","Pain that interferes with ability to participate in the study's upper extremity movement tasks.","Have impaired decision making capacity as determined by the U-ARE protocol for assessing capacity to provide informed consent.","Inclusion Criteria:\n\n* Self-reported stroke-related deficits in emotional wellness such as anxiety, sleep disturbance, dread, fear, loss of hope, sadness.\n* Have experienced ischemic or hemorrhagic stroke at least 30 days prior\n* Stroke-related aphasia and\u002For upper extremity hemiparesis\n* Aged 21 years or older\n* English as primary language\n* Have corrected vision to be able to read text on a screen\n* Able to participate fully in the study's tele-rehabilitation (Aim 1) and\u002For virtual group programing (Aim 2) with personally owned device (i.e., phone, tablet, or laptop) and personal Wi-Fi connection or cellular service\n* Cognitive, language, and motor capacity to participate fully in the study's assessment session as per the judgment of the licensed, experienced stroke tele-rehabilitation occupational or speech therapist\n\nExclusion Criteria:\n\n* Unable to follow 1-2 step instructions given by the study team member during the informed consent procedures.\n* Pain that interferes with ability to participate in the study's upper extremity movement tasks.\n* Have impaired decision making capacity as determined by the U-ARE protocol for assessing capacity to provide informed consent.",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":13,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":88},"Charleston","South Carolina","29425","United States",[83],{"name":84,"role":85,"phone":86,"email":87},"Kelly Rishe, MSOT","CONTACT","843-985-1810","callahk@musc.edu",{"lat":89,"lon":90},32.77632,-79.93275,[92],{"name":93,"role":85,"phone":94,"email":95},"Patricia Finetto","843-792-8533","piersonp@musc.edu",[97,100,102],{"name":98,"affiliation":13,"role":99},"Michelle Woodbury, PhD","PRINCIPAL_INVESTIGATOR",{"name":101,"affiliation":13,"role":99},"Lisa McTeague, PhD",{"name":103,"affiliation":104,"role":99},"Deena Blackett, PhD","University of Central Florida",[106,110,113,116,119,122,125,128,130,132,135],{"pmid":107,"type":108,"citation":109},"24375225","BACKGROUND","Ayerbe L, Ayis SA, Crichton S, Wolfe CD, Rudd AG. Natural history, predictors and associated outcomes of anxiety up to 10 years after stroke: the South London Stroke Register. Age Ageing. 2014 Jul;43(4):542-7. doi: 10.1093\u002Fageing\u002Faft208. Epub 2013 Dec 26.",{"pmid":111,"type":108,"citation":112},"25117911","Hackett ML, Pickles K. Part I: frequency of depression after stroke: an updated systematic review and meta-analysis of observational studies. Int J Stroke. 2014 Dec;9(8):1017-25. doi: 10.1111\u002Fijs.12357. Epub 2014 Aug 12.",{"pmid":114,"type":108,"citation":115},"29097059","Bhattacharjee S, Axon DR, Goldstone L, Lee JK. Patterns and Predictors of Depression Treatment among Stroke Survivors with Depression in Ambulatory Settings in the United States. J Stroke Cerebrovasc Dis. 2018 Mar;27(3):563-567. doi: 10.1016\u002Fj.jstrokecerebrovasdis.2017.09.047. Epub 2017 Oct 31.",{"pmid":117,"type":108,"citation":118},"31507525","Paolucci S, Iosa M, Coiro P, Venturiero V, Savo A, De Angelis D, Morone G. Post-stroke Depression Increases Disability More Than 15% in Ischemic Stroke Survivors: A Case-Control Study. Front Neurol. 2019 Aug 27;10:926. doi: 10.3389\u002Ffneur.2019.00926. eCollection 2019.",{"pmid":120,"type":108,"citation":121},"33213019","Kowalska K, Krzywoszanski L, Dros J, Pasinska P, Wilk A, Klimkowicz-Mrowiec A. Early Depression Independently of Other Neuropsychiatric Conditions, Influences Disability and Mortality after Stroke (Research Study-Part of PROPOLIS Study). Biomedicines. 2020 Nov 17;8(11):509. doi: 10.3390\u002Fbiomedicines8110509.",{"pmid":123,"type":108,"citation":124},"21441153","McKevitt C, Fudge N, Redfern J, Sheldenkar A, Crichton S, Rudd AR, Forster A, Young J, Nazareth I, Silver LE, Rothwell PM, Wolfe CD. Self-reported long-term needs after stroke. Stroke. 2011 May;42(5):1398-403. doi: 10.1161\u002FSTROKEAHA.110.598839. Epub 2011 Mar 24.",{"pmid":126,"type":108,"citation":127},"26118139","Skolarus LE, Lisabeth LD, Burke JF, Levine DA, Morgenstern LB, Williams LS, Pfeiffer PN, Brown DL. Racial and Ethnic Differences in Mental Distress among Stroke Survivors. Ethn Dis. 2015 Spring;25(2):138-44.",{"type":108,"citation":129},"HRSA. Behavioral Health Workforce, 2023. In: HRSA, editor.: National Center for Health Workforce Analysis; 2023.",{"type":108,"citation":131},"Services UDoHaH. South Carolina Mental Health Health Professional Shortage Areas (HPSA): GIS Office of Information Technology; 2023 [updated 03-07-2023]. Available from: https:\u002F\u002Fscdhec.gov\u002Fsites\u002Fdefault\u002Ffiles\u002Fmedia\u002Fdocument\u002FHPSA-Mental-Health-2023.pdf.",{"pmid":133,"type":108,"citation":134},"31868663","Hamilton RKB, Phelan CH, Chin NA, Wyman MF, Lambrou N, Cobb N, Kind AJH, Blazel H, Asthana S, Gleason CE. The U-ARE Protocol: A Pragmatic Approach to Decisional Capacity Assessment for Clinical Research. J Alzheimers Dis. 2020;73(2):431-442. doi: 10.3233\u002FJAD-190457.",{"pmid":136,"type":108,"citation":137},"18042300","Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186\u002F1477-7525-5-63.",[],{"nct_id":4,"conditions":140,"biomarkers":141},[19],[],{"nct_id":4,"found":143,"summary":144,"prompt_version":154},true,{"design":145,"status":146,"heading":147,"summary":148,"follow_up":149,"word_count":150,"commitments":151,"compensation":152,"drugs_mentioned":153},"This interventional study plans to enroll 80 participants. Participants will be randomly assigned to one of two groups, both receiving OT or ST, with one group also receiving an emotional wellness component.","completed","Emotional Recovery Post-Stroke Study","This study is looking at whether adding an emotional wellness program to therapy helps people recover after a stroke. We want to see if combining modified Cognitive Behavioral Therapy (mCBT) with occupational therapy (OT) or speech therapy (ST) improves your emotional well-being and ability to participate in daily activities. You might be able to join if you've had a stroke at least 30 days ago, are 21 or older, speak English, and have emotional challenges like anxiety or sadness, or physical issues like difficulty speaking or moving an arm. The study aims to see if these therapies improve your mental well-being, how well you can do daily tasks, and your quality of life. The current recruitment status is unclear.","Your progress will be measured at the beginning, before therapy, and immediately after the 8-week intervention period.",119,"You will complete 9 therapy sessions over 8 weeks, each lasting about 1 hour, through video calls. You will also have two assessment visits, one before and one after the therapy program, also via video call.","Not stated in the trial record.",[34],"v2"]