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Completed

NCT Number: NCT05598047

Executive Functioning Training Study

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

OVERALL -- A pre-post three-group experimental design will be used. Participants will be recruited from the University of Alabama at Birmingham (UAB) 1917 HIV/AIDS Clinic which has a patient population of +3,600 and is the largest HIV medical provider within 100 miles. Eligible participants will be consented at the UAB Center for Research on Applied Gerontology where a ~2 hr baseline assessment will be administered. Participants' neuropsychological data gathered at baseline will be examined to determine a HAND classification. Only participants with HIV-Associated Neurocognitive Disorder (HAND) will be invited to continue with the study. Stratified random assignment will ensure an equal number of participants in each group by gender, minority status, and with/without executive functioning impairment (i.e., 1 standard deviation below normative mean). After training, participants will complete a posttest assessment.

Recruitment/Retention Strategies. As effective in our studies, recruitment/retention strategies will be used. 1) Recruitment materials distributed in the UAB 1917 HIV/AIDS Clinic. 2) Reminder letters and telephone calls will be used before the scheduled visit. 3) Beverages/snacks will be provided (from departmental funds). 5) Secondary contact information will be collected to follow up with lost participants.

Intervention Protocol BrainHQ (POSIT Science Inc.) cognitive training modules will be used as in our other studies; these programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises. The intervention will be administered in the research lab of the UAB Center for Applied Gerontology where many of our other studies have been conducted. Working with BrainHQ, when logging on, participants can only receive the individualized cognitive training exercises they are assigned.

Executive Functioning Training Group. Those in the Executive Functioning Training Group will engage in exercises requiring one to set shift; that is, to maintain at least two sets of rules and decide which is appropriate to determine the response. In using these training exercises in the Training On Purpose Study (TOPS), the effects size was quite large (d=-0.89). Dosage of 20 hours of training is considered an upper range on how much training is needed to produce an optimal therapeutic effect.

No-Contact Control Group. This group will receive no intervention. As this is a pilot/feasibility study, investigators do not have the resources to provide a contact control group. Importantly, in a prior study, investigators established that a no-contact control group and a contact control (sham) group did not significantly differ from each other and both served as an excellent comparison to a cognitive intervention.

Instruments Administration time of the assessment will be ~2 hrs. Investigators will use REDCap and BrainBaseline Assessment of Cognition and Everyday Functioning (BRACE+) tablet for administration of the instruments below to reduce tester burden, tester error, and improve the efficiency of data entry and data management, which will save significant staff time and resources. Other cognitive studies as observed in the HIV Neurobehavioral Research Center (HNRC) group employ testing assessments of similar length. BRACE+ was develop in conjunction with HNRC.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants (men & women) must be 40+ years
  • English speaking,
  • Willing to meet in person
  • Has time to participate for ~12 weeks

Exclusion criteria

  • Participants living beyond 60 miles away from the center
  • Participants 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

Treatment and study plan

Executive Functioning Training

Behavioral

Those in the Executive Functioning Training Group will engage in exercises requiring one to set shift; that is, to maintain at least two sets of rules and decide which is appropriate to determine the response. In using these training exercises in the TOPS study, the effects size was quite large (d=-0.89). Dosage of 20 hours of training is considered an upper range on how much training is needed to produce an optimal therapeutic effect.

Primary outcomes

  1. Self-Perceived Need for Cognitive Training

    Time frame: ~12 weeks

    Participants rated whether they need computerize cognitive training to improve their cognition (scale from 0=not at all to 10=extremely).

  2. Cognitive Training Satisfaction

    Time frame: ~12 weeks

    Participants were asked how much they enjoyed the cognitive training (scale from 1=not at all to 5=extremely).

  3. Cognitive Training Preferences

    Time frame: ~12 weeks

    Investigators administer a qualitative (i.e., open-ended responses) survey to assess what participants liked/disliked (i.e. preferences) about the training and how to improve it. These verbal responses were then coded into categories for those who were assigned to the EFT group.

  4. Hours of Cognitive Training Completed

    Time frame: From enrollment through completion on average around 12 weeks

    Investigators calculated the hours of training completed. Ranges will be from 0 to 20 hours (i.e., 0% to 100%).

  5. Attrition Rates (After Study Data Collection)

    Time frame: From enrollment through completion on average around 12 weeks

    Investigators calculated the attrition rate of the protocol as measured by those who completed a posttest assessment; this was the indicator that participants completed the study.

Secondary outcomes

  1. Cognitive Inconsistency (Cognitive Intra-individual Variability)

    Time frame: ~12 weeks

    Cognitive Inconsistency (a type of cognitive intra-individual variability) was calculated with Variability (measures consistency of participants hit reaction times during the test) and Hit Rate Standard Deviation (measures consistency of response speed). These are measured in T scores; 50 indicates a population mean with a standard deviation of 10. Higher T scores indicate more inconsistency, which is considered a poorer cognitive indicator. There is no clinically relevant threshold.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Executive Function Training to Reduce Cognitive Intra-Individual Variability in Adults With HIV

Acronym: EFT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2022
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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