[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541513":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":51,"studyPopulation":43,"armGroups":52,"interventions":64,"overallOfficials":74,"centralContacts":78,"locations":83,"responsibleParty":102,"collaborators":43,"id":105,"slug":43,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":43,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":43,"enrollmentInfo":113,"targetDuration":43,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":43,"overallStatus":85,"whyStopped":43,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Rosalind Franklin University of Medicine and Science","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":43,"otherOutcomes":43},[9,13,16,19,22,25,28,31,34,37,40],{"measure":10,"description":11,"timeFrame":12},"Verbal learning and memory","Assessed by the California Verbal Learning Test- Second Edition (CVLT-II)","up to eight weeks",{"measure":14,"description":15,"timeFrame":12},"Basic auditory attention and working memory","Assessed by the Digit Span subtest of the Wechsler Adult Intelligence Scale (WAIS-IV)",{"measure":17,"description":18,"timeFrame":12},"Psychomotor processing speed","Assessed by the Coding and Symbol search subtests of the WAIS-IV",{"measure":20,"description":21,"timeFrame":12},"Psychomotor processing speed; executive functioning","As assessed by the Stroop Test",{"measure":23,"description":24,"timeFrame":12},"Self-report of prospective and retrospective memory","The Prospective and Retrospective Memory Questionnaire (PRMQ). The PRMQ developed to provide a self-report measure of prospective and retrospective memory slips in everyday life. It consists of sixteen items, eight asking about prospective memory failures, and eight concerning retrospective failures.",{"measure":26,"description":27,"timeFrame":12},"Self-report of cognitive concerns","Neuro-QOL (neuro-quality of life); applied cognition: general concerns \\& executive functioning (EF) subscales",{"measure":29,"description":30,"timeFrame":12},"The Patient Health Questionnaire-9","(i.e., PHQ-9; assessing self-report symptoms of depression)",{"measure":32,"description":33,"timeFrame":12},"Self-report symptoms of anxiety","As assessed by the Generalized Anxiety Disorder-7 questionnaire (i.e., GAD-7)",{"measure":35,"description":36,"timeFrame":12},"Self-reported daily functioning","As assessed by The World Health Organization Disability Assessment Schedule 2.0 (i.e., WHODAS 2.0)",{"measure":38,"description":39,"timeFrame":12},"The Racial Microaggressions Scale","Assessing the occurrence and distress elicited by racial indignities, slights, mistreatment, or offenses that people of color may face on a recurrent or consistent basis.",{"measure":41,"description":42,"timeFrame":12},"The Trauma Symptoms of Discrimination Scale","Self-report measure assessing the traumatizing impact of discrimination broadly by measuring anxiety-related symptoms of trauma due to discriminatory experiences",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":43,"timePerspective":43,"maskingInfo":49},"RANDOMIZED","PARALLEL","Two groups assignment - One group will complete the original ME-CCT training program. The other group will complete the newly developed RBSE-CCT-MCI.","TREATMENT",{"masking":50,"maskingDescription":43,"whoMasked":43},"NONE","African American (AA) individuals are at higher risk for non-normative cognitive decline, particularly due to increased rates of cardiovascular and cerebrovascular risk factors. These types of risk factors (e.g., hypertension, diabetes mellitus, obesity, hyperlipidemia, etc.) are independently associated with brain imaging changes, even before potential clinical manifestation of cardiovascular or cerebrovascular disease.\n\nWhen compared to the general aging population, AA adults experience disproportionately higher rates of hypertension as well as both an earlier age of onset and higher concomitant morbidity and mortality from hypertension when compared to any other racial\u002Fethnic group in the US. AA individuals experience greater exposure to specific chronic stressors, such as discrimination and low socioeconomic status, as well as report higher overall levels of stress compared to white individuals. However, racial disparities in hypertension rates persist even after controlling for socioeconomic status. Researchers have failed to demonstrate any risk factors that are biologically unique to AA patients. These findings have led researchers to consider other psychosocial and environmental factors that may explain the observed hypertension disparities, namely, racial discrimination and racial segregation.\n\nAA older adults are not only at higher risk for non-normative cognitive decline due to both semi-direct (i.e., increased risk of cardiovascular\u002Fcerebrovascular risk factors, such as HTN), but other factors such as race-related stress may not only exacerbate these risk factors, but also interfere day-to-day with optimal cognitive performance due to overall increased stress and diversion of cognitive resources. Therefore, for AA older adults, there is an increased need not only for interventions that help to compensate for cognitive decline and increase daily functioning, but also an increased need for an intervention to reduce the effects of race-related stressors. The proposed Race-Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI) as proposed in this pilot, is one such intervention that would accomplish those aims and has the potential for a significant impact on patient care for AA older adults who could benefit from additional tools and strategies to improve cognitive functioning and increase day-to-day independent functioning.\n\nOf note, original authors of both protocols have granted consent for modifications of their interventions, and the investigators already have a draft of the new protocol.",[53,59],{"label":54,"type":55,"description":56,"interventionNames":57},"Experimental: RBSEF-CCT-MCI","EXPERIMENTAL","Participants will complete the newly developed RBSE-CCT-MCI training program.",[58],"Behavioral: Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI)",{"label":60,"type":6,"description":61,"interventionNames":62},"Control Group: ME-CCT","Participants will complete the original, ME-CCT training program.",[63],"Behavioral: Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT)",[65,70],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":43},"BEHAVIORAL","Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI)","RBSEF-CCT-MCI differs from ME-CCT in that this intervention integrates psychoeducation and strategies for processing and coping with race\u002Fethnicity-related stressors, as part of the larger conversation in ME-CCT regarding stress, and how stress interferes with attention, learning, and subsequently one's subjective sense of memory.",[54],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":43},"Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT)","ME-CCT focuses on:\n\n1. Cognitive training, psychotherapeutic, and lifestyle techniques.\n2. Incorporates CCT techniques designed to help patients manage problems with memory, attention, and executive functions (i.e., organization, planning, decision-making, and problem-solving).\n3. Includes mindfulness-based stress reduction practice which has been shown to improve cognitive and neuropsychiatric function in various populations.",[60],[75],{"name":76,"affiliation":5,"role":77},"Rachael L Ellison, PhD","PRINCIPAL_INVESTIGATOR",[79],{"name":76,"role":80,"phone":81,"phoneExt":43,"email":82},"CONTACT","(847) 578-3000","rachael.ellison@rosalindfranklin.edu",[84],{"facility":5,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"RECRUITING","Chicago","Illinois","60064","United States","US",{"type":92,"coordinates":93},"Point",[94,95],-87.65005,41.85003,{"lat":95,"lon":94},[98,101],{"name":99,"role":80,"phone":100,"phoneExt":43,"email":43},"Rachael Ellison, PhD","312-940-1718",{"name":99,"role":77,"phone":43,"phoneExt":43,"email":43},{"type":77,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Rachael Ellison","Principle Investigator","100541513",false,"NCT06330844","Race-Based Stress and Cognitive Training for MCI","Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment","Inclusion Criteria:\n\n* The study will be conducted in-person, so they must be able to travel to Rosalind Franklin University.\n* The study will initially be limited to participants who self-identify as Black\u002FAfrican American, or who self-identify with other racial\u002Fethnic groups in addition to self-identifying as Black\u002FAfrican-American; however, may be expanded to include participants that identify as Hispanic\u002FLatine.\n\nExclusion Criteria:\n\n* Participants are ineligible to participate in this study if they are not at least 65 years of age and are not experiencing at least mild cognitive impairment or self-reported cognitive difficulties.\n* Participants will also be excluded if they have a diagnosis of dementia (i.e., major neurocognitive disorder), intellectual disability, mild head injury (i.e., concussion) within the last six months, and\u002For a history of moderate to severe traumatic brain injury.\n* Diagnosis of dementia may be from self-report or other medical records, or for participants to fail screening cognitive assessments (i.e., the RBANS) that would suggest they may be at the level of dementia (i.e., major neurocognitive disorder) as ultimately determined by study PI with objective scores less then 2 standard deviations below the mean on the RBANS.","ALL","65 Years",{"count":114,"type":115},9,"ESTIMATED","INTERVENTIONAL",[118],"NA","This a two phase project that aims to pilot a new adaptation (Phase 1) of Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT; an originally VA-based cognitive rehabilitation manualized intervention for older adults with MCI, with a focus on the impact of stress on cognitive functioning; that integrates components from the Race Based Stress and Empowerment (RBSE) group for an increased focus on race-based stress and discrimination for racial minority older adults (i.e., RBSEF-CCT-MCI). In a pilot open trial, 75-150 participants will receive group-based intervention for 8 weeks, with 8-10 participants per group.\n\nFollowing the pilot study, the investigators will complete a randomized controlled trial (RCT) (Phase 2) to compare the efficacy of the RBSEF-CCT-MCI with the ME-CCT. In the RCT, 75-150 participants will be randomized into either 1) The active control group, who will complete the original, ME-CCT training program, or 2) The experimental group, who will complete the newly developed RBSE-CCT-MCI. Both research groups will complete the interventions for 8 weeks, with 8-10 participants per group.\n\nHypothesis: Participation in this newly developed\u002Fupdated intervention (i.e., RBSEF-CCT-MCI) will result in improvements in both (a) subjective and (b) objective cognitive functioning, and (c) self-reported mental health symptoms.",[121],"Mild Cognitive Impairment","2025-07-21",{"date":124,"type":125},"2025-07-24","ACTUAL",{"date":127,"type":125},"2025-03-01",{"date":129,"type":115},"2028-03-15",{"name":5,"class":6},1]