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NCT05598047
Executive Functioning Training Study
Conditions: Aging, Cognitive Function Abnormal, Cognitive Performance, Cognitive Training, Older Adults
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: 1
Phase: PHASE2
Enrollment: 150
Sponsor: University of Alabama at Birmingham
Summary
Cognitive aging in people with HIV (PWH) is of increasing concern for several reasons: 1) between 52%-59% of PWH experience cognitive impairment known as HIV-Associated Neurocognitive Disorder (HAND) which impacts everyday functioning and quality of life; 2) HAND increases in severity and prevalence with age; and 3) 70% of PWH in the United States will be 50 and older by 2030.
Fortunately, cognitive training programs can individually target specific cognitive impairments in PWH and possibly reduce the severity and prevalence of HAND and improve everyday functioning and quality of life.
This approach is based around the underlying concept of intra-individual variability as controlled through higher level allocation of cognitive resources, known as executive functioning.
This feasibility study will use a two-group pre-post experimental design of adults with HAND including: 1) a 20-hours of Executive Functioning Training group (enroll 60, n=48 with attrition), and 2) a no-contact control (enroll 60, n=48 with attrition).
Aim 1 - Feasibility: To determine feasibility and acceptability of the intervention (i.e., attrition, feedback).
Exploratory Aim 1 - Cognition: Compare adults who receive Executive Functioning Training to those who receive no training to determine whether they improve in global cognitive ability and overall cognitive IIV.
This high impact study is innovative in the following ways: 1) This is the first study aimed to reduce cognitive IIV in PWH. 2) This is the first study to use IIV as a guide to target solely executive functioning training to improve global cognitive ability, which may reduce the severity and prevalence of HAND.
3) Over the last decade, the epicenter of HIV has emerged in the Deep South where this study will occur.
Most participants in this study will be older PWH who identify as lower social economic status (SES) and/or African Americans and experience HAND symptoms.
Eligibility Criteria
Inclusion Criteria:Participants (men & women) must be 40+ yearsEnglish speaking,Have HIV-Associated Neurocognitive Disorder (HAND)Willing to meet in personHas time to participate for ~12 weeksExclusion Criteria:Participants living beyond 60 miles away from the centerParticipants living in unstable housing (e.g., halfway house)Participants with significant neuromedical comorbidities (e.g., schizophrenia)Participants with other conditions (e.g., legally blind/deaf, currently undergoing radiation or chemotherapy, or a history of significant brain trauma, diagnosed with COVID-19 over the past 3 months) that could impact cognitive functioning or testing.Participants who have received cognitive training within the past three years
Source: ClinicalTrials.gov (NCT05598047). StuddyBuddy aggregates publicly available trial information.