Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Cognitive Training (ACT) | Experimental | Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 8 weeks. |
|
| Control Training (CON) | Sham Comparator | Participants will complete 48 training sessions over 8 weeks. The control games are not designed to enhance memory. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Cognitive Training (ACT) | Device | Cognitive training games |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christina S. Meade, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27708 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control Training (CON) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | Score on a scale | Baseline; post-training, approximately 8 weeks |
|
Approximately 17 weeks (from Baseline to the follow-up assessment)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sheri Towe | Duke University School of Medicine | 919-668-4030 | sheri.towe@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2018 | Sep 30, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control Training (CON) | Device | Cognitive training games |
|
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Participants will complete 48 training sessions over 10 weeks. The control games are not designed to enhance memory. Control Training (CON): Cognitive training games |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Wechsler Test of Adult Reading (WTAR) | A word reading test that estimates premorbid verbal Intelligence Quotient (IQ). An intelligence quotient is a total score derived from several standardized tests designed to assess human intelligence. The WTAR comprises 50 words with irregular pronunciations that participants read aloud. The raw score on the WTAR ranges from 0 to 50. The raw score is transformed to an age-adjusted standard score (range 50-134), which is on the same scale as a full IQ test (M = 100; SD = 15). The age-adjusted standard WTAR score is used to provide an estimate for the full-scale IQ and is reported here. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Error | percentage of doses | 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. | Posted | Mean | Standard Error | score on a scale | 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. | Posted | Mean | Standard Error | days | Baseline; post-training, approximately 8 weeks |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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 | 0 | 29 | 0 | 29 | 0 | 29 |
Not provided
Not provided
Not provided