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Project IMPACT: Improving Memory Performance by Applying Cognitive Training

2019年10月25日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

58

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • North Carolina
      • Durham、North Carolina、アメリカ、27708
        • Duke University Medical Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~60年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的: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
他の名前:
  • 光度
偽コンパレータ:Control Training (CON)
Participants will complete 48 training sessions over 8 weeks. The control games are not designed to enhance memory.
Cognitive training games
他の名前:
  • 光度

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Working Memory Assessed by Domain Deficit Score
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Christina S. Meade, PhD、Duke University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年3月1日

一次修了 (実際)

2019年2月23日

研究の完了 (実際)

2019年2月23日

試験登録日

最初に提出

2016年9月16日

QC基準を満たした最初の提出物

2016年9月19日

最初の投稿 (見積もり)

2016年9月21日

学習記録の更新

投稿された最後の更新 (実際)

2019年10月30日

QC基準を満たした最後の更新が送信されました

2019年10月25日

最終確認日

2019年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Pro00053630_1

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

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