Project IMPACT: Improving Memory Performance by Applying Cognitive Training
Cognitive Training to Reduce Impulsivity in HIV-infected Cocaine Users
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
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
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
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
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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Experimental: 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
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
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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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
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
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
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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
Zeitfenster: Baseline; post-training, approximately 8 weeks
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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
Sponsor
Sponsor
Ermittler
Ermittler
- Hauptermittler: Christina S. Meade, PhD, Duke University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- Pro00053630_1
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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