- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02909101
Project IMPACT: Improving Memory Performance by Applying Cognitive Training
2019년 10월 25일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
58
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27708
- Duke University Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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
다른 이름들:
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가짜 비교기: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Working Memory Assessed by Domain Deficit Score
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Christina S. Meade, PhD, Duke University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 3월 1일
기본 완료 (실제)
2019년 2월 23일
연구 완료 (실제)
2019년 2월 23일
연구 등록 날짜
최초 제출
2016년 9월 16일
QC 기준을 충족하는 최초 제출
2016년 9월 19일
처음 게시됨 (추정)
2016년 9월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 10월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 10월 25일
마지막으로 확인됨
2019년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .