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Project IMPACT: Improving Memory Performance by Applying Cognitive Training

25 octobre 2019 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

58

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • North Carolina
      • Durham, North Carolina, États-Unis, 27708
        • Duke University Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Active Cognitive Training (ACT)
Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 8 weeks.
Cognitive training games
Autres noms:
  • Luminosité
Comparateur factice: Control Training (CON)
Participants will complete 48 training sessions over 8 weeks. The control games are not designed to enhance memory.
Cognitive training games
Autres noms:
  • Luminosité

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Working Memory Assessed by Domain Deficit Score
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Christina S. Meade, PhD, Duke University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2017

Achèvement primaire (Réel)

23 février 2019

Achèvement de l'étude (Réel)

23 février 2019

Dates d'inscription aux études

Première soumission

16 septembre 2016

Première soumission répondant aux critères de contrôle qualité

19 septembre 2016

Première publication (Estimation)

21 septembre 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 octobre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 octobre 2019

Dernière vérification

1 octobre 2019

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • Pro00053630_1

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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