- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02909101
Project IMPACT: Improving Memory Performance by Applying Cognitive Training
25 października 2019 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
58
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
North Carolina
-
Durham, North Carolina, Stany Zjednoczone, 27708
- Duke University Medical Center
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 60 lat (Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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
Inne nazwy:
|
|
Pozorny komparator: Control Training (CON)
Participants will complete 48 training sessions over 8 weeks.
The control games are not designed to enhance memory.
|
Cognitive training games
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Working Memory Assessed by Domain Deficit Score
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Christina S. Meade, PhD, Duke University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 marca 2017
Zakończenie podstawowe (Rzeczywisty)
23 lutego 2019
Ukończenie studiów (Rzeczywisty)
23 lutego 2019
Daty rejestracji na studia
Pierwszy przesłany
16 września 2016
Pierwszy przesłany, który spełnia kryteria kontroli jakości
19 września 2016
Pierwszy wysłany (Oszacować)
21 września 2016
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
30 października 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
25 października 2019
Ostatnia weryfikacja
1 października 2019
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- Pro00053630_1
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Tak
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .