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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a method to assist older adults living with HIV who face cognitive challenges affecting their daily lives. Many individuals with HIV experience HIV-Associated Neurocognitive Disorder (HAND), which can make thinking and remembering difficult as they age. The trial tests a program called Executive Functioning Training, which uses engaging, computer-based exercises to enhance brain skills. Individuals living with HIV who notice memory or attention issues and can commit to a 12-week program might be suitable candidates for this study. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

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 prior data suggests that this Executive Functioning Training is safe for aging adults with HIV?

Research has shown that Executive Functioning Training is generally safe for adults with HIV. This non-invasive training does not involve surgery or entering the body and is considered low-risk. Studies have found that these programs can enhance thinking skills and daily activities for people with HIV. Participants typically find the computer-based exercises easy to handle. Past research has reported no major side effects, indicating that the treatment is safe and manageable for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Executive Functioning Training for cognitive impairment in aging adults with HIV because it offers a unique, game-based approach to cognitive enhancement. Unlike traditional treatments that might involve medication or conventional therapy sessions, this method uses BrainHQ's interactive, computerized training modules focused on executive functioning skills. These modules are self-administered on tablets, making it more accessible and engaging, especially for those unfamiliar with technology. The training is designed to be both fun and effective, with sessions optimized for maximum benefit in just 60 minutes, one to three times a week. This innovative approach not only targets cognitive skills but also encourages consistent participation through its gaming elements.

What evidence suggests that Executive Functioning Training is effective for cognitive impairment in aging adults with HIV?

Research has shown that training programs focused on improving thinking skills can help people with HIV. In this trial, participants in the Executive Functioning Training arm will use computer-based exercises to enhance daily life and mental abilities. Studies have found that these programs work well, especially with short, regular sessions. Participants in these programs have demonstrated improved planning and decision-making skills, which are important for handling everyday tasks. This training might also help lessen the impact of HIV-Associated Neurocognitive Disorder (HAND). ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8895263/

Evaluation of Computerized Cognitive Training and Cognitive ... This meta-analysis found that CCT programs were associated with improvements in cognitive and daily function among people living with HIV.

2. tandfonline.com tandfonline.com/doi/full/10.2147/NRR.S492990?af=R

Executive Functioning Training for Reducing Cognitive ... Background and Purpose. Cognitive training programs have been attempted to improve cognition in cognitively vulnerable people living with HIV (PLWH).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03122288

NCT03122288 | Individualized Cognitive Training in HIV Such cognitive training programs may be effective in older adults with HIV and therefore investigators may be able to change the diagnosis of HAND in such ...

4. dovepress.com dovepress.com/a-brief-report-of-an-executive-functioning-training-pilot-rct-in-adult-peer-reviewed-fulltext-article-NRR

A Brief Report of an Executive Functioning Training Pilot ... Fortunately, cognitive training studies using executive functioning training have been able to improve this cognitive ability in older adults ...

5. withpower.com withpower.com/trial/phase-2-cognitive-dysfunction-2023-ae7fe

Executive Functioning Training for Cognitive Impairment in ... Cognitive training programs may effectively improve cognitive function in adults living with HIV, as shown in a systematic review of 13 studies, with some ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10651797/

A 2-year Longitudinal Randomized Controlled Trial Examining ... This study examined the effect of SOP training has on secondary cognitive domains in PWH aged 40+ years.

7. dovepress.com dovepress.com/article/download/100245

Executive Functioning Training for Reducing Cognitive ... After 1 to 6 months of cognitive training, both the. HIV-negative group and the PLWH group showed decreased frontal brain activation, indicating ...