- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02909101
Project IMPACT: Improving Memory Performance by Applying Cognitive Training
25 ottobre 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
58
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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North Carolina
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Durham, North Carolina, Stati Uniti, 27708
- Duke University Medical Center
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 60 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Active Cognitive Training (ACT)
Participants will complete computerized games designed to enhance working memory.
Participants will complete 48 training sessions over 8 weeks.
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Cognitive training games
Altri nomi:
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Comparatore fittizio: Control Training (CON)
Participants will complete 48 training sessions over 8 weeks.
The control games are not designed to enhance memory.
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Cognitive training games
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Working Memory Assessed by Domain Deficit Score
Lasso di tempo: Baseline; post-training, approximately 8 weeks
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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.
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Baseline; post-training, approximately 8 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)
Lasso di tempo: Baseline; post-training, approximately 8 weeks
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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.
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Baseline; post-training, approximately 8 weeks
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Acceptability as Measured by Participant Ratings
Lasso di tempo: Post-training, approximately 8 weeks
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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.
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Post-training, approximately 8 weeks
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Acceptability as Measured by Participant Perception of Benefits and Barriers to Completing Sessions
Lasso di tempo: Post-training, approximately 8 weeks
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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.
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Post-training, approximately 8 weeks
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Percent Medication Adherence Across All Antiretroviral Medications
Lasso di tempo: Baseline; post-training, approximately 8 weeks
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0% indicates no doses of medications were taken, and 100% means all doses were taken.
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Baseline; post-training, approximately 8 weeks
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Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB)
Lasso di tempo: Baseline; post-training, approximately 8 weeks
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The RAB is a standardized survey.
Scores range from 0 to 18, with higher scores meaning greater sexual risk.
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Baseline; post-training, approximately 8 weeks
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Number of Days of Cocaine Use as Measured by Timeline Followback Interview Methodology
Lasso di tempo: 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.
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Baseline; post-training, approximately 8 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Christina S. Meade, PhD, Duke University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 marzo 2017
Completamento primario (Effettivo)
23 febbraio 2019
Completamento dello studio (Effettivo)
23 febbraio 2019
Date di iscrizione allo studio
Primo inviato
16 settembre 2016
Primo inviato che soddisfa i criteri di controllo qualità
19 settembre 2016
Primo Inserito (Stima)
21 settembre 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
30 ottobre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 ottobre 2019
Ultimo verificato
1 ottobre 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- Pro00053630_1
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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