- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02909101
Project IMPACT: Improving Memory Performance by Applying Cognitive Training
25. Oktober 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
58
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 27708
- Duke University Medical Center
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 60 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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
Andere Namen:
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Schein-Komparator: 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
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Working Memory Assessed by Domain Deficit Score
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)
Zeitfenster: 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.
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Baseline; post-training, approximately 8 weeks
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Acceptability as Measured by Participant Ratings
Zeitfenster: 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.
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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
Zeitfenster: 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.
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Post-training, approximately 8 weeks
|
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Percent Medication Adherence Across All Antiretroviral Medications
Zeitfenster: 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)
Zeitfenster: 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.
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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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Christina S. Meade, PhD, Duke University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. März 2017
Primärer Abschluss (Tatsächlich)
23. Februar 2019
Studienabschluss (Tatsächlich)
23. Februar 2019
Studienanmeldedaten
Zuerst eingereicht
16. September 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. September 2016
Zuerst gepostet (Schätzen)
21. September 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
30. Oktober 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
25. Oktober 2019
Zuletzt verifiziert
1. Oktober 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- Pro00053630_1
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Ja
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