Duke University Medical Center
Durham, North Carolina, 27708, United States
NCT Number: NCT02909101
The purpose of this study is to examine the effects of a cognitive training program in persons with Human Immunodeficiency Virus (HIV) infection who have used cocaine. This study tests the feasibility and preliminary efficacy of a computerized cognitive training program to improve working memory and decrease impulsivity (delay discounting) among HIV-infected individuals.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Durham, North Carolina, 27708, United States
Of the 1.2 million Americans living with HIV, over half experience neurocognitive impairments (NCI) that adversely affect daily living and are predictive of increased morbidity and mortality. HIV-infected individuals who are addicted to stimulant drugs like cocaine are at even higher risk for NCI, which contributes to impulsive decision making, and engage in high rates of risky behaviors that are associated with both poor clinical outcomes and HIV transmission to others. Delay discounting, a key aspect of impulsivity, describes the tendency to devalue a reward as the delay to its receipt increases. Individuals addicted to drugs tend to prefer smaller, immediate rewards over larger, delayed rewards. Excessive discounting is associated with a wide range of other health risk behaviors, including risky sex. The Competing Neurobehavioral Decision Systems model posits that excessive discounting results from greater relative strength of the impulsive system over the executive control system. The investigators' own work suggests that HIV infection modulates the effect of cocaine on brain functioning in the executive control network during delay discounting. Prior research supports a robust association between excessive discounting and working memory impairment. As a core executive function that supports self-regulation, working memory is theoretically an intervention target for HIV risk reduction. Computerized working memory training has been shown to decrease delay discounting in stimulant users, but it has not yet been tested in HIV-infected drug users. The proposed R21 study will test the preliminary efficacy of a computerized cognitive training program to improve working memory and reduce delay discounting in HIV-infected cocaine users. Using a randomized trial design, the investigators will assign 50 participants to either the experimental cognitive training condition or an attention-matched control condition. Participants will complete 48 sessions in 8 weeks, with assessments at baseline, post-training, and 1-month follow-up to evaluate intervention effects. The investigators hypothesize that cognitive training will, relative to the control condition, lead to greater improvements in working memory and reductions in delay discounting. The investigators will also examine change in HIV risk behaviors (cocaine use, risky sex, and medication adherence). Results will support an R01 application for a larger scale trial to rigorously test the impact of cognitive training on HIV-related behavioral and clinical outcomes. This innovative line of research has important translational implications for HIV clinical practice, including dissemination in resource-limited settings with few neuropsychology specialists. This proposal directly advances a high priority topic for AIDS-designated funding by testing a novel treatment for HIV-associated NCI in drug users. By focusing on a high-risk population that continues to drive HIV transmission, this research has strong potential to improve neurobehavioral functioning in HIV-infected persons, and ultimately to reduce the incidence of new HIV infections.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cognitive training games
Other names: Lumosity
Cognitive training games
Other names: Lumosity
Time frame: Baseline; post-training, approximately 8 weeks
Measured by domain deficit score, which is a continuous measure of overall impairment on the domain. 0 means no impairment and 5 means highest possible impairment.
Time frame: Baseline; post-training, approximately 8 weeks
The Monetary Choice Questionnaire (MCQ) is a standardized delay discounting task. Because scores are on a logarithmic scale, they were rank ordered for analysis. Ranks range from 1 to 13, with higher ranks meaning higher impulsivity.
Time frame: Post-training, approximately 8 weeks
Participants rated how satisfied they found the intervention on a 5 point scale (with 1 being very dissatisfied and 5 being very satisfied). Acceptability was defined a priori of achieving a mean rating of >3.5 on the 5 point scale.
Time frame: Post-training, approximately 8 weeks
Participants rated how helpful they found the intervention on a 5 point scale (with 1 being very unhelpful and 5 being very helpful). Acceptability was defined a priori of achieving a mean rating of >3.5 on the 5 point scale for helpfulness.
Time frame: Baseline; post-training, approximately 8 weeks
0% indicates no doses of medications were taken, and 100% means all doses were taken.
Time frame: Baseline; post-training, approximately 8 weeks
The RAB is a standardized survey. Scores range from 0 to 18, with higher scores meaning greater sexual risk.
Time frame: Baseline; post-training, approximately 8 weeks
The Timeline Followback Method involves asking subjects to retrospectively estimate their cocaine use 30 days prior to the interview date. Responses therefore range from 0 to 30 days.
Duke University
Other
Cognitive Training to Reduce Impulsivity in HIV-infected Cocaine Users
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