Project IMPACT: Improving Memory Performance by Applying Cognitive Training

HIV Clinical Trial

Official title:

Cognitive Training to Reduce Impulsivity in HIV-infected Cocaine Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909101
• Other study ID #: Pro00053630_1
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: February 23, 2019

Study information

• Verified date: October 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 23, 2019
• Est. primary completion date: February 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• HIV infection

• currently on antiretroviral medications for >3 months

• cocaine use as defined by crack/cocaine use in the past month, cocaine-type stimulant use disorder, and cocaine as the principal substance of abuse

• working memory impairment as defined by scoring >1 standard deviation below the normative mean on at least 2 out of the 3 working memory tests

Exclusion Criteria:

• pregnancy

• English non-fluency or illiteracy

• <8th grade education

• serious neurological disorders including HIV dementia, traumatic brain injury, severe mental illness, or acute psychiatric distress

• impaired mental status

• individuals who state they are planning to move away from the area within the next 3 months

• individuals without stable housing

Related Conditions & MeSH terms

• Cocaine Use Disorders
• HIV

Intervention

Device:
• Active Cognitive Training (ACT)
Cognitive training games
• Control Training (CON)
Cognitive training games

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Working Memory Assessed by Domain Deficit Score	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.	Baseline; post-training, approximately 8 weeks
Secondary	Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)	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.	Baseline; post-training, approximately 8 weeks
Secondary	Acceptability as Measured by Participant Ratings	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.	Post-training, approximately 8 weeks
Secondary	Acceptability as Measured by Participant Perception of Benefits and Barriers to Completing Sessions	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.	Post-training, approximately 8 weeks
Secondary	Percent Medication Adherence Across All Antiretroviral Medications	0% indicates no doses of medications were taken, and 100% means all doses were taken.	Baseline; post-training, approximately 8 weeks
Secondary	Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB)	The RAB is a standardized survey. Scores range from 0 to 18, with higher scores meaning greater sexual risk.	Baseline; post-training, approximately 8 weeks
Secondary	Number of Days of Cocaine Use as Measured by Timeline Followback Interview Methodology	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.	Baseline; post-training, approximately 8 weeks