Cocaine Use Disorders, HIV
Conditions
Keywords
Working memory, cognitive training, HIV, substance abuse
Brief 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.
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.
Interventions
Cognitive training games
DEVICEControl Training (CON)
Cognitive training games
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Working Memory Assessed by Domain Deficit Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability as Measured by Participant Ratings | 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. |
| Acceptability as Measured by Participant Perception of Benefits and Barriers to Completing Sessions | 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. |
| Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ) | 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. |
| Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB) | 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. |
| Number of Days of Cocaine Use as Measured by Timeline Followback Interview Methodology | 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. |
| Percent Medication Adherence Across All Antiretroviral Medications | Baseline; post-training, approximately 8 weeks | 0% indicates no doses of medications were taken, and 100% means all doses were taken. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Cognitive Training (ACT) Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 10 weeks.
Active Cognitive Training (ACT): Cognitive training games | 29 |
| Control Training (CON) Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory.
Control Training (CON): Cognitive training games | 29 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Active Cognitive Training (ACT) | Control Training (CON) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 29 Participants | 29 Participants |
| Age, Continuous | 48.62 years STANDARD_DEVIATION 9.15 | 48.97 years STANDARD_DEVIATION 10.09 | 48.28 years STANDARD_DEVIATION 8.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 29 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants | 26 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 58 Participants | 29 Participants | 29 Participants |
| Sex: Female, Male Female | 17 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 41 Participants | 24 Participants | 17 Participants |
| Wechsler Test of Adult Reading (WTAR) | 82.55 units on a scale STANDARD_DEVIATION 14 | 81.97 units on a scale STANDARD_DEVIATION 14.47 | 83.14 units on a scale STANDARD_DEVIATION 13.75 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
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.
Time frame: Baseline; post-training, approximately 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Cognitive Training (ACT) | Working Memory Assessed by Domain Deficit Score | Baseline | .29 Score on a scale | Standard Error 0.09 |
| Active Cognitive Training (ACT) | Working Memory Assessed by Domain Deficit Score | Post-training | .14 Score on a scale | Standard Error 0.07 |
| Control Training (CON) | Working Memory Assessed by Domain Deficit Score | Baseline | .21 Score on a scale | Standard Error 0.09 |
| Control Training (CON) | Working Memory Assessed by Domain Deficit Score | Post-training | .26 Score on a scale | Standard Error 0.07 |
Comparison: Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.p-value: 0.039ANCOVA
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.
Time frame: Post-training, approximately 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Cognitive Training (ACT) | Acceptability as Measured by Participant Perception of Benefits and Barriers to Completing Sessions | 4.14 score on a scale | Standard Deviation 1.15 |
| Control Training (CON) | Acceptability as Measured by Participant Perception of Benefits and Barriers to Completing Sessions | 4.04 score on a scale | Standard Deviation 1.02 |
Comparison: To determine acceptability in terms of helpfulness, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.p-value: 0.719t-test, 2 sided
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.
Time frame: Post-training, approximately 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Cognitive Training (ACT) | Acceptability as Measured by Participant Ratings | 4.04 score on a scale | Standard Deviation 1.32 |
| Control Training (CON) | Acceptability as Measured by Participant Ratings | 4.14 score on a scale | Standard Deviation 1.11 |
Comparison: To determine acceptability, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.p-value: 0.744t-test, 2 sided
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.
Time frame: Baseline; post-training, approximately 8 weeks
Population: One participant from ACT and two participants from CON were excluded because they did not provide valid responses on the MCQ at the post-training follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Cognitive Training (ACT) | Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ) | Baseline | 8.70 score on a scale | Standard Error 0.41 |
| Active Cognitive Training (ACT) | Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ) | Post-training | 8.38 score on a scale | Standard Error 0.37 |
| Control Training (CON) | Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ) | Baseline | 7.97 score on a scale | Standard Error 0.42 |
| Control Training (CON) | Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ) | Post-training | 8.76 score on a scale | Standard Error 0.38 |
Comparison: Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.p-value: 0.054ANCOVA
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.
Time frame: Baseline; post-training, approximately 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Cognitive Training (ACT) | Number of Days of Cocaine Use as Measured by Timeline Followback Interview Methodology | Baseline | 7.51 days | Standard Error 1.68 |
| Active Cognitive Training (ACT) | Number of Days of Cocaine Use as Measured by Timeline Followback Interview Methodology | Post-training | 8.49 days | Standard Error 1.72 |
| Control Training (CON) | Number of Days of Cocaine Use as Measured by Timeline Followback Interview Methodology | Baseline | 6.88 days | Standard Error 1.68 |
| Control Training (CON) | Number of Days of Cocaine Use as Measured by Timeline Followback Interview Methodology | Post-training | 5.12 days | Standard Error 1.72 |
Comparison: Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.p-value: 0.133ANCOVA
Secondary
Percent Medication Adherence Across All Antiretroviral Medications
0% indicates no doses of medications were taken, and 100% means all doses were taken.
Time frame: Baseline; post-training, approximately 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Cognitive Training (ACT) | Percent Medication Adherence Across All Antiretroviral Medications | Baseline | 96.53 percentage of doses | Standard Error 2.29 |
| Active Cognitive Training (ACT) | Percent Medication Adherence Across All Antiretroviral Medications | Post-training | 96.08 percentage of doses | Standard Error 2.19 |
| Control Training (CON) | Percent Medication Adherence Across All Antiretroviral Medications | Baseline | 88.97 percentage of doses | Standard Error 2.29 |
| Control Training (CON) | Percent Medication Adherence Across All Antiretroviral Medications | Post-training | 92.03 percentage of doses | Standard Error 2.19 |
Comparison: Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.p-value: 0.337ANCOVA
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.
Time frame: Baseline; post-training, approximately 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Cognitive Training (ACT) | Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB) | Post-training | 4.04 score on a scale | Standard Error 0.47 |
| Active Cognitive Training (ACT) | Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB) | Baseline | 4.53 score on a scale | Standard Error 0.43 |
| Control Training (CON) | Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB) | Baseline | 3.68 score on a scale | Standard Error 0.43 |
| Control Training (CON) | Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB) | Post-training | 4.21 score on a scale | Standard Error 0.47 |
Comparison: Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.p-value: 0.025ANCOVA