Speed of Processing Training in Adults With HIV



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:40 - Any
Updated:11/18/2018
Start Date:April 2016
End Date:April 2021
Contact:David E Vance, PhD
Email:devance@uab.edu
Phone:205-934-7589

Use our guide to learn which trials are right for you!

An RCT of Speed of Processing Training in Middle-Aged and Older Adults With HIV

As people age with HIV, the synergistic effects with normal age-related cognitive declines
will accentuate and/or accelerate declines in cognitive functioning which can be detected as
early in one's 40s. Although interventions are needed to protect/improve cognitive
functioning, one intervention already exists to improve speed of processing. NINR/NIA
(January 14, 2014) announced that Speed of Processing Training used in the ACTIVE Study (N =
2,802 community-dwelling older adults) has the ability to enable "older people to maintain
their cognitive abilities as they age" even 10 years after training. As shown in the ACTIVE
Study, this intervention uniquely improves driving, instrumental activities of daily living
(IADL), health-related quality of life, self-rated health, internal locus of control, and
protects one from depression; these represent areas of needed intervention for adults with
HIV as well. In adults with HIV, previous pilot studies likewise indicate speed of processing
declines are associated with poorer driving simulator performance and more self-reported
at-fault automobile crashes; such speed of processing declines on driving alone represent a
significant public health concern. These studies also demonstrated that Speed of Processing
Training improved this cognitive ability and translated into improved performance on a timed
measure of IADLs. Based on prior research, this RCT proposal consists of a pre-post two-year
longitudinal experimental design whereby 264 adults with HIV, 40+ years and diagnosed with
HIV-Associated Neurocognitive Disorder, will be randomly assigned to one of three training
conditions: 1) 10 hours of laboratory-based Speed of Processing Training, 2) 20 hours of
laboratory-based Speed of Processing Training, or 3) 10 hours of a standardized
computer-contact control (sham) condition.

AIM 1: Determine whether 10 vs 20 hours of speed of processing training will improve this
cognitive ability at post-test, year 1, and year 2 after baseline.

AIM 2: Determine whether 10 vs 20 hours of speed of processing training will improve everyday
functioning at post-test, year 1, and year 2 after baseline.

Exploratory AIM: Determine whether improvement in speed in speed of processing and/or
everyday functioning over time mediate improvement quality of life (e.g., depression, health
related quality of life).

SPECIFIC AIMS

This research directly meets the goals of the NIH Cognitive and Emotional Health Project and
the Healthy Brain Initiative which seek to "maintain or improve the cognitive performance of
all adults," especially for "populations experiencing the greatest disparities and risks in
cognitive health."

Significance: Using Fascati criteria, 52% - 59% of people with HIV experience HIV-associated
Neurocognitive Disorder (HAND) which affects driving safety, medication adherence, and
instrumental activities of daily living (IADLs). Cognitive aging in this group represents a
major concern since by 2020, 70% of adults with HIV in the United States will be 50 and
older. Thus, there is a growing population that is particularly vulnerable to HAND due to the
co-occurrence with aging-related cognitive impairments. In our prior study (R03MH076642-01A2)
conducted in the HAART era, when comparing cognitive functioning between older and younger
HIV-positive and HIV-negative adults, older adults with HIV performed the worst. In the HAART
era, these cognitive impairments continue to be observed in several cognitive domains
including memory, reasoning/executive functioning, and one area of particular importance -
speed of processing.

Speed of processing is the rate at which cognitive functions are performed. People with HIV
are vulnerable to speed of processing declines, especially as they age. Such speed of
processing declines are associated with poorer driving performance, and more at-fault crashes
in normal older adults, as well as middle-aged (40+) and older adults with HIV, which is a
growing public health concern. In the Southern U.S., specifically in the Deep South where
this study will occur, these points are highly relevant because: 1) even with speed of
processing declines, adults with HIV must rely on their own driving, especially in rural
areas with limited public transportation; and 2) the epicenter of HIV has emerged here in the
last decade, which means many lower SES adults and/or African Americans with HIV will also
have HAND or borderline HAND. Regrettably, few behavioral interventions have tried to improve
cognition in this pharmacologically-burdened population; and pharmacological cognitive
interventions produce adverse side effects in a population already experiencing multiple
comorbidities. Fortunately, some types of computerized cognitive interventions have been
shown to improve cognition without adverse side-effects. Yet, only two types of computerized
cognitive interventions have been conducted in adults with HIV, with one being Speed of
Processing Training.

Specific Aim 1: Determine whether 10 vs 20 hours of Speed of Processing Training will improve
this cognitive ability at post-test, year 1, and year 2 after baseline. Hypothesis 1- Adults
with HAND or borderline HAND will have improved speed of processing over time as they engage
in more hours of training compared to those in the contact control (sham) condition.

Specific Aim 2: Determine whether 10 vs 20 hours of Speed of Processing Training will improve
everyday functioning at post-test, year 1, and year 2 after baseline. Hypothesis 2- Adults
with HAND or borderline HAND will have improved everyday functioning (e.g., IADLs, driving,
medication adherence) over time as they engage in more hours of training compared to those in
the contact control (sham) condition.

Exploratory Aim: Determine whether improvement in speed of processing and/or everyday
functioning over time mediate improvement in quality of life (e.g., depression, locus of
control, health-related quality of life).

Innovation: We are the first to develop Speed of Processing Training and use it with older
adults and those with HIV. This non-pharmacological intervention improves the rate at which
normal, community-dwelling older adults process information and has been shown to improve
performance in driving, IADLs, and health-related quality of life several years after
training. In prior studies, we demonstrated that after only 10 hours of Speed of Processing
Training, this inexpensive intervention significantly improved speed of processing and IADLs
in adults with HIV in the short-term. As part of the ACTIVE Study (N = 2,802), three types of
cognitive training in 6 sites across the U.S. were compared: speed of processing, memory, and
reasoning. NINR/NIA (January 14, 2014) announced that Speed of Processing Training used in
the ACTIVE Study enabled "older people to maintain their cognitive abilities as they age,"
even 10 years after training. The ACTIVE Study also examined reasoning and memory training;
however, Speed of Processing Training was uniquely found also to enhance tertiary outcomes:
(1) protect against depression and (2) improve self-rated health, internal locus of control,
and health-related quality of life. These tertiary/quality of life outcomes are essential
areas in HIV that likewise require intervention. This RCT of 264 adults with HAND or
borderline HAND will extend the ability to demonstrate that we cannot only improve speed of
processing and everyday functioning in the short-term, but over a 2-year period.

Inclusion Criteria:

- Since driving-related factors are being examined as one of the outcomes of the
intervention, participants must be licensed drivers when entering the study.

- Men and/or women

- Must be 40+ years

- English speaking

- Have HIV-Associated Neurocognitive Disorder (HAND) or borderline HAND (defined using
Frascati criteria).

Exclusion Criteria:

- Because this study is longitudinal, participants not living in stable housing (e.g.,
halfway house) will be excluded.

- Potential participants will be excluded if they indicate that they are planning to
move outside of the Birmingham metropolitan area within the next 2 years.

- Participants with significant neuromedical co-morbidities (e.g., schizophrenia,
epilepsy, bipolar disorder, multiple sclerosis, Alzheimer's disease or related
dementias, mental retardation)

- Legally blind or deaf (vision confirmed at baseline)

- Currently undergoing radiation or chemotherapy

- A history of brain trauma with a loss of consciousness greater than 30 minutes

- Those who have participated in our pilot studies and were randomized to the Speed of
Processing Training will be excluded.
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-934-7589
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials