Executive Functioning Training Study

NCT05598047 | Completed Phase 2 Results DMC

• 2 other identifiers: IRB 3000085615R21AG077957-02
• Study Type: interventional
• Target: 119
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Aging; Cognitive Function Abnormal; Cognitive Performance; Cognitive Training; Older Adults

Outcome Measures

Primary Outcomes (5)

• Self-Perceived Need for Cognitive Training

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

  ~12 weeks

• Cognitive Training Satisfaction

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

  ~12 weeks

• Cognitive Training Preferences

  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.

  ~12 weeks

• Hours of Cognitive Training Completed

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

  From enrollment through completion on average around 12 weeks

• Attrition Rates (After Study Data Collection)

  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.

  From enrollment through completion on average around 12 weeks

Secondary Outcomes (1)

• Cognitive Inconsistency (Cognitive Intra-individual Variability)

  ~12 weeks

Study Arms (2)

Executive Functioning Training

EXPERIMENTAL

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.

Behavioral: Executive Functioning Training

No-Contact Control Group

NO INTERVENTION

These participants will not receive any intervention.

Interventions

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.

Executive Functioning Training

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Aging (NIA): collaborator

Related Publications (3)

• Vance DE, Fazeli PL, Azuero A, Wadley VG, Raper JL, Ball KK. Can Individualized-Targeted Computerized Cognitive Training Benefit Adults with HIV-Associated Neurocognitive Disorder? The Training on Purpose Study (TOPS). AIDS Behav. 2021 Dec;25(12):3898-3908. doi: 10.1007/s10461-021-03230-y. Epub 2021 Mar 18.

  PMID: 33733311 BACKGROUND

• Vance DE, Fazeli PL, Cheatwood J, Nicholson C, Morrison S, Moneyham LD. Targeting HIV-Related Neurocognitive Impairments with Cognitive Training Strategies: Insights from the Cognitive Aging Literature. Curr Top Behav Neurosci. 2021;50:503-515. doi: 10.1007/7854_2018_80.

  PMID: 30710223 BACKGROUND

• Waldrop D, Irwin C, Nicholson WC, Lee CA, Webel A, Fazeli PL, Vance DE. The Intersection of Cognitive Ability and HIV: A Review of the State of the Nursing Science. J Assoc Nurses AIDS Care. 2021 May-Jun 01;32(3):306-321. doi: 10.1097/JNC.0000000000000232.

  PMID: 33449578 BACKGROUND

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

The analysis presented here is a strict intent to treat analysis. Dosage (i.e., amount of actual cognitive training that was delivered) may impact the findings. This is a large data set that is nuanced; we will continue to mine these data to examine for other patterns related to the feasibility and cognitive outcomes.

Results Point of Contact

• Title: David Vance, PhD, University Professor
• Organization: University of Alabama at Birmingham

devance@uab.edu

205-934-7589

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A pre-post two-group experimental design will be used. One group will receive the experimental executive functioning training and the other group will not receive anything (no-contact control group)

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 28, 2022
• Study Start: June 13, 2023
• Primary Completion: April 8, 2025
• Study Completion: April 8, 2025
• Last Updated: May 20, 2026
• Results First Posted: May 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon completion of the study
• Access Criteria: Based upon IRB approval and Data Use Agreement.