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Testing a Computerized Cognitive Training Protocol in Adults Aging With HIV-Associated Neurocognitive Disorders: Randomized Controlled Trial Rationale and Protocol.

ABSTRACT: BACKGROUND:HIV-associated neurocognitive disorders occur in nearly 50% of adults with HIV. Such disorders can interfere with everyday functioning such as driving and medication adherence. Therefore, cognitive interventions are needed to address such neurocognitive disorders as well as improve everyday functioning, especially as people age with HIV. OBJECTIVE:This article reports and discusses the overall rationale and development of speed of processing training, a computerized Internet cognitive training program, to improve this specific neurocognitive ability as well as everyday functioning and quality of life in adults aging with HIV. Although this protocol has been shown to improve speed of processing, everyday functioning, and quality of life in healthy, community-dwelling older adults in the advanced cognitive training in vital elderly (ACTIVE) study, its efficacy in adults aging with HIV has not been established. Nevertheless, such a cognitive intervention is particularly germane as 52%-59% of adults with HIV experience HIV-associated neurocognitive disorders (HAND), and both the frequency and severity of such disorders may increase with advancing age. METHODS:The description of this longitudinal randomized controlled trial covers the following: (1) rationale for speed of processing training in this clinical population, (2) overview of overall study design, (3) eligibility criteria and HAND, (4) intervention dosage, (5) assessment battery, and (6) examination of biomarkers. RESULTS:The project was funded in April 2016 and enrolment is on-going. The first results are expected to be submitted for publication in 2020. CONCLUSIONS:Similar novel cognitive intervention approaches are suggested as they may be of value to those with HAND and may utilize similar features of this current randomized controlled trial (RCT) protocol to examine their therapeutic efficacy. TRIAL REGISTRATION:ClinicalTrials.gov NCT02758093; https://clinicaltrials.gov/ct2/show/NCT02758093 (Archived by Webcite at http://www.webcitation.org/6p8C5fBCX).

SUBMITTER: Vance D

PROVIDER: S-EPMC5422019 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Testing a Computerized Cognitive Training Protocol in Adults Aging With HIV-Associated Neurocognitive Disorders: Randomized Controlled Trial Rationale and Protocol.

Vance David D Fazeli Pariya P Shacka John J Nicholson William W McKie Peggy P Raper James J Azuero Andres A Wadley Virginia V Ball Karlene K

JMIR research protocols 20170426 4

<h4>Background</h4>HIV-associated neurocognitive disorders occur in nearly 50% of adults with HIV. Such disorders can interfere with everyday functioning such as driving and medication adherence. Therefore, cognitive interventions are needed to address such neurocognitive disorders as well as improve everyday functioning, especially as people age with HIV.<h4>Objective</h4>This article reports and discusses the overall rationale and development of speed of processing training, a computerized Int ...[more]

PMID: 28446421

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Project description:Children with genetic neurodevelopmental disorders (NDDs) such as Down syndrome, Prader-Willi syndrome, and Fragile X syndrome may show a range of cognitive impairments, including impairments in executive functions (EF). EF are related to general intelligence, academic achievement, and literacy and mathematical skills. EF deficits are linked to a variety of clinically and socially important behaviors. Therefore, methods for improving EF in children with NDDs could be beneficial. One method for improving EF is through cognitive training. Research on commercial brain training programmes and video games suggests that EF can be improved through training, both in healthy adults and in children with NDDs. Computerized cognitive training (CCT) therefore represents a potentially viable intervention for children with NDDs. For training to be effective, it is important that an appropriate regimen is followed. Since children are likely to engage with training at home, the intentions of their parents to support them are therefore important. However, no research has investigated the attitudes of parents of children with NDDs to CCT. To address this, we developed a questionnaire based on the theory of planned behavior, which states that a person's intention to engage in a behavior is predicted by (1) their attitude toward the behavior, (2) their perception of subjective norms regarding the behavior (i.e., perceived social pressure), and (3) their perceived control over the behavior. The questionnaire was completed by parents of children with NDDs; 58 unique responses were retained for analyses. Parents reported low levels of knowledge of CCTs, and low levels of experience with CCTs (both their own experience and their child's experience). However, our results also show that parents of children with NDDs have positive beliefs about the potential of CCT to benefit their children and intend to support the use of CCT by their children. Linear modeling showed that, of the three constructs of the theory of planned behavior, only attitudes significantly predicted intention. Finally, parents' beliefs about the benefits of CCT correlated positively with positive attitudes toward such training. We also found limited evidence that parents of boys have more positive attitudes regarding CCT than parents of girls.

Project description:BackgroundSince the introduction of antiretroviral therapy (ART), the incidence of HIV-associated dementia has drastically fallen. Despite using ART, people living with HIV continue to experience less severe but limiting forms of HIV-associated neurocognitive disorder (HAND). People living with HIV who are on ART and experiencing symptoms of HAND may benefit from aerobic exercise.ObjectiveThis protocol describes a randomized controlled trial designed to determine the effects of a 12-week aerobic exercise program on HAND in Southeastern Nigeria.MethodsAt least 68 patients diagnosed with HAND will be randomly placed into either an aerobic exercise group or control group. Patients in the aerobic exercise group will perform a moderate intensity workout on a stationary bicycle ergometer, 3 times a week for 12 weeks. We will measure the primary outcomes including neurocognitive performance, prevalence of HAND, viral load, and CD4 count. We will evaluate postexercise neurocognitive performance using reliable neuropsychological tests relevant to people living with HIV, in line with the Frascati criteria. We will assess secondary outcomes such as quality of life, activity limitation, and social participation using the World Health Organization Quality of Life (WHOQOL)-Brief, and the Oxford Participation and Activities questionnaire. We will use exploratory statistics to test the data for normality and homogeneity. We will analyze the effect of the exercise program on HAND using relative risk (RR) and absolute risk reduction (number needed to treat). Analysis of covariance will be run to estimate the effect of exercise on quality of life and activity and participation level.ResultsThis funded trial was approved by the Institutional Review Board in May 2020. The protocol was approved on June 15, 2020. Enrollment commenced in January 2021 and was completed in May 2021. Over 60% of the participants were recruited at the time of first submission to JMIR Mental Health. Data curation is still ongoing; hence, data analysis is yet to be executed. Study outcomes are expected to be published in March 2022.ConclusionsThis is a protocol for a randomized controlled trial that aims to evaluate the effect of a 12-week aerobic exercise program on HAND in Southeastern Nigeria.Trial registrationPan African Clinical Trials Registry PACTR202009483415745; https://tinyurl.com/2p97zpu9.International registered report identifier (irrid)PRR1-10.2196/29230.

Dataset Information

Testing a Computerized Cognitive Training Protocol in Adults Aging With HIV-Associated Neurocognitive Disorders: Randomized Controlled Trial Rationale and Protocol.

Publications

Testing a Computerized Cognitive Training Protocol in Adults Aging With HIV-Associated Neurocognitive Disorders: Randomized Controlled Trial Rationale and Protocol.

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