Executive Functioning Training for Cognitive Impairment in Aging Adults with HIV

(EFT Trial)

Overseen By DAVID E VANCE

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

Disqualifiers: Schizophrenia, Brain trauma, Chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a computer program with brain exercises to help adults with HIV who have cognitive issues. The exercises aim to improve thinking skills by requiring participants to switch between tasks and make decisions. This could help reduce cognitive problems and improve daily functioning.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Executive Functioning Training for cognitive impairment in aging adults with HIV?

Research shows that computerized cognitive training, which includes executive functioning training, can improve cognitive functions like working memory and speed of processing in people with HIV. Studies suggest that these improvements can enhance everyday activities and quality of life, and may even reverse cognitive impairments associated with HIV. ^{1 2 3 4 5}

Is cognitive training safe for aging adults with HIV?

Current research suggests that cognitive training is generally safe for adults with HIV, as it is a non-invasive, low-risk intervention that has been positively received by participants in studies. ^{1 2 4 5 6}

How is Executive Functioning Training different from other treatments for cognitive impairment in aging adults with HIV?

Executive Functioning Training is unique because it uses computerized cognitive exercises to specifically target and improve areas of cognitive weakness, such as memory and attention, in people with HIV. Unlike pharmaceutical treatments, which may have side effects, this non-drug approach is low-cost and can potentially reverse cognitive impairments without the risks associated with medication. ^{1 2 4 5 6}

Eligibility Criteria

This trial is for English-speaking adults over 40 with HIV-Associated Neurocognitive Disorder (HAND) who can meet in person and commit to a ~12-week program. It's not for those with major health issues like schizophrenia, significant brain trauma, or recent COVID-19 infection; those undergoing intense treatments like chemo; or individuals living far from the center or in unstable housing.

Inclusion Criteria

I am 40 years old or older.

Participants must be English speaking

I am willing to attend in-person meetings.

Exclusion Criteria

I do not have conditions affecting my thinking or senses, nor am I currently undergoing major treatments.

I live more than 60 miles away from the treatment center.

Participants with significant neuromedical comorbidities (e.g., schizophrenia)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo a baseline assessment to determine HAND classification and eligibility for the study

2 hours

1 visit (in-person)

Treatment

Participants in the Executive Functioning Training group engage in 20 hours of cognitive training using BrainHQ modules

12 weeks

Self-administered sessions, 1-3 times per week

Follow-up

Participants are monitored for cognitive improvements and adherence to the training protocol

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• Executive Functioning Training

Trial Overview The study tests if Executive Functioning Training over 20 hours improves cognitive abilities in aging adults with HAND compared to no training. Participants are split into two groups: one receives the training and the other doesn't, allowing researchers to see if there's an improvement in cognitive functioning.

Participant Groups

Group I: Executive Functioning Training Experimental Treatment 1 Intervention

BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. 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.

Group II: No-Contact Control Group Active Control 1 Intervention

These participants will not receive any intervention.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

Cognitive training programs may effectively improve cognitive function in adults living with HIV, as shown in a systematic review of 13 studies, with some evidence suggesting reversal of HIV-associated neurocognitive disorder in individual cases.

Improvements in cognitive function from these training programs can lead to better everyday functioning, enhanced mood, and an overall improved quality of life for individuals with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training for the Neurocognitive Complications of HIV Infection: A Systematic Review. Vance, DE., Fazeli, PL., Cheatwood, J., et al.[2019]

A randomized clinical trial involving 21 adults living with HIV showed that computerized cognitive training significantly improved working memory function over 10 weeks, while a control group showed no change.

Participants found the cognitive training program to be feasible and acceptable, indicating its potential as a low-cost intervention for addressing neurocognitive impairments in people living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Acceptability and Potential Utility of Cognitive Training to Improve Working Memory in Persons Living With HIV: A Preliminary Randomized Trial. Towe, SL., Patel, P., Meade, CS.[2018]

Speed of processing training significantly improved cognitive functioning and everyday activities in middle-aged and older adults with HIV, suggesting it can enhance quality of life for those with cognitive vulnerabilities.

Participants who started with poorer performance on cognitive tests, such as the Useful Field of View and Timed Instrumental Activities of Daily Living, showed greater improvements, indicating that those most in need of support may benefit the most from this training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of improvement following speed of processing training in middle-aged and older adults with HIV: a pilot study. Kaur, J., Dodson, JE., Steadman, L., et al.[2023]

About 50% of older adults with HIV are diagnosed with HIV-associated neurocognitive disorders (HAND), which can significantly impact their daily lives and overall quality of life.

Cognitive training has shown promise in improving cognitive function in older adults and may help reverse HAND, with ongoing clinical trials suggesting that effective interventions could be developed for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting HIV-Related Neurocognitive Impairments with Cognitive Training Strategies: Insights from the Cognitive Aging Literature. Vance, DE., Fazeli, PL., Cheatwood, J., et al.[2021]

Nearly 50% of adults with HIV experience HIV-associated neurocognitive disorder (HAND), which can significantly impact their daily functioning and quality of life.

The ongoing TOPS study, involving 146 older adults with HAND, is testing whether individualized cognitive training can improve specific cognitive deficits, potentially reversing the diagnosis of HAND and offering a new treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can computerized cognitive training reverse the diagnosis of HIV-associated neurocognitive disorder? A research protocol. Vance, DE., Fazeli, PL., Azuero, A., et al.[2019]

Over 50% of adults with HIV experience some form of neurocognitive disorder, which can worsen with age and related health issues, highlighting the need for effective interventions.

Cognitive training strategies have been shown to improve neurocognitive function and daily living skills in older adults with HIV, offering a safer alternative to pharmaceutical treatments that may pose risks due to compromised organ function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remediating HIV-Associated Neurocognitive Disorders via Cognitive Training: A Perspective on Neurocognitive Aging. Vance, DE., Cody, SL., Moneyham, L.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training for the Neurocognitive Complications of HIV Infection: A Systematic Review. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The Acceptability and Potential Utility of Cognitive Training to Improve Working Memory in Persons Living With HIV: A Preliminary Randomized Trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Predictors of improvement following speed of processing training in middle-aged and older adults with HIV: a pilot study. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Targeting HIV-Related Neurocognitive Impairments with Cognitive Training Strategies: Insights from the Cognitive Aging Literature. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Can computerized cognitive training reverse the diagnosis of HIV-associated neurocognitive disorder? A research protocol. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Remediating HIV-Associated Neurocognitive Disorders via Cognitive Training: A Perspective on Neurocognitive Aging. [2017]