Project IMPACT: Improving Memory Performance by Applying Cognitive Training

October 25, 2019 updated by: Duke University

Cognitive Training to Reduce Impulsivity in HIV-infected Cocaine Users

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Cognitive Training (ACT)
Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 8 weeks.
Device: Active Cognitive Training (ACT)
Cognitive training games
Other Names:
  • Lumosity
Sham Comparator: Control Training (CON)
Participants will complete 48 training sessions over 8 weeks. The control games are not designed to enhance memory.
Device: Control Training (CON)
Cognitive training games
Other Names:
  • Lumosity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Working Memory Assessed by Domain Deficit Score
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.
Baseline; post-training, approximately 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)
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.
Baseline; post-training, approximately 8 weeks
Acceptability as Measured by Participant Ratings
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.
Post-training, approximately 8 weeks
Acceptability as Measured by Participant Perception of Benefits and Barriers to Completing Sessions
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.
Post-training, approximately 8 weeks
Percent Medication Adherence Across All Antiretroviral Medications
Time Frame: Baseline; post-training, approximately 8 weeks
0% indicates no doses of medications were taken, and 100% means all doses were taken.
Baseline; post-training, approximately 8 weeks
Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB)
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.
Baseline; post-training, approximately 8 weeks
Number of Days of Cocaine Use as Measured by Timeline Followback Interview Methodology
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.
Baseline; post-training, approximately 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Christina S. Meade, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

February 23, 2019

Study Completion (Actual)

February 23, 2019

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00053630_1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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