Race-Based Stress and Cognitive Training for MCI
ConditionMild Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorRosalind Franklin University of Medicine and Science
About this trial
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.
Following 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.
Hypothesis: Participation in this newly developed/updated 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The study will be conducted in-person, so they must be able to travel to Rosalind Franklin University.
The study will initially be limited to participants who self-identify as Black/African American, or who self-identify with other racial/ethnic groups in addition to self-identifying as Black/African-American; however, may be expanded to include participants that identify as Hispanic/Latine.
Disqualifiers
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.
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/or a history of moderate to severe traumatic brain injury.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI)
BehavioralRBSEF-CCT-MCI differs from ME-CCT in that this intervention integrates psychoeducation and strategies for processing and coping with race/ethnicity-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.
Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT)
BehavioralME-CCT focuses on: 1. Cognitive training, psychotherapeutic, and lifestyle techniques. 2. Incorporates CCT techniques designed to help patients manage problems with memory, attention, and executive functions (i.e., organization, planning, decision-making, and problem-solving). 3. Includes mindfulness-based stress reduction practice which has been shown to improve cognitive and neuropsychiatric function in various populations.
Treatment groups
9 Participants
are divided into 2 treatment groupsGroup A: Experimental: RBSEF-CCT-MCIExperimental treatment 1 intervention
Group B: Control Group: ME-CCTOther 1 intervention
Trial outcomes
Primary outcomes
1
Verbal learning and memory
Assessed by the California Verbal Learning Test- Second Edition (CVLT-II)
Time frame
up to eight weeks2
Basic auditory attention and working memory
Assessed by the Digit Span subtest of the Wechsler Adult Intelligence Scale (WAIS-IV)
Time frame
up to eight weeks3
Psychomotor processing speed
Assessed by the Coding and Symbol search subtests of the WAIS-IV
Time frame
up to eight weeks4
Psychomotor processing speed; executive functioning
As assessed by the Stroop Test
Time frame
up to eight weeksSponsors and contacts
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Source ClinicalTrials.gov