跳至主要内容
临床试验/NCT03501706
NCT03501706招募中不适用

Remediation of Elevated Delay Discounting in Mid-life Individuals: A Stage-II Trial

University of Kansas2 个研究点 分布在 1 个国家目标入组 680 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
680
试验地点
2
主要终点
Change in Delay Discounting (DD)

研究概览

简要总结

Many health-relevant decisions involve intertemporal (now vs. later) tradeoffs. Extensive literature indicates that many negative health and financial consequences suffered in mid-life are linked to adversity and disadvantage during early developmental periods of life. Individuals who continue to engage in these types of unhealthy behaviors despite awareness of the health consequences are exhibiting an inability to delay gratification.

Delay discounting (DD) is quantified in human studies by determining the rate at which an individual discounts a delayed reward, while executive function (EF) is defined as the set of cognitive processes that are responsible for helping individuals manage life tasks and achieve goals. This research will attempt to reduce DD via EF training in a population of mid-life individuals with risk factors established during early-life disadvantage.

详细描述

Many health-relevant decisions involve intertemporal (now vs. later) tradeoffs, where unhealthy choices involve immediate benefits and delayed costs, compared to healthy choices with immediate costs and delayed benefits. Reinforcement for unhealthy behaviors are immediate, while the reinforcement for healthier alternatives are delayed. Thus individuals who continue to engage in these types of unhealthy behaviors despite awareness of the health consequences are exhibiting an inability to delay gratification.

Delay discounting (DD) is quantified in human studies by determining the rate at which an individual discounts a delayed reward, typically assessed by having subjects choose between a rewards available immediately and a larger reward available following a delay. For the purpose of this study, the investigators define executive function (EF) as the set of cognitive processes that are responsible for helping individuals manage life tasks and achieve goals (e.g., planning, working memory).

The approach of targeting preference for immediate rewards (exhibited by elevated DD) is highly innovative. Multiple studies provide compelling evidence that strengthening EF may decrease DD. Extensive literature indicates that many negative health and financial consequences suffered in mid-life are linked to adversity and disadvantage during early developmental periods of life. By targeting a mechanism of various negative aging-related outcomes (elevated DD), the proposed research may have the novel impact on broadly remediating the health and wellness of mid-life individuals at increased risk for poor consequences due to early-life disadvantage.

This research will attempt to reduce Delay Discounting via Executive Functioning training in a population of mid-life individuals with risk factors established during early-life disadvantage. DD, EF, and associated health behaviors/outcomes will be assessed at baseline, following training, and at 3- and 6-month follow-up. Participants will receive Active EF training, or Control training. Given the established effect of Active training in reducing DD in stimulant-dependent individuals, the study team expect reductions in DD, improvements in EF, and improvements in associated health behaviors/outcomes following Active training and at follow-up, with no improvements in the Control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Community members in neighborhoods of Baltimore, Maryland
  • Participants willing to participate in the 5-7 week program

排除标准

  • Participants with a severe substance use disorder according to the DSM-5 with any substance other than tobacco
  • Participants with any significant medical or psychiatric condition which the training is not designed for (e.g., traumatic brain injury, dementia, significant learning disability, or schizophrenia)
  • Participants with severe depression

结局指标

主要结局

Change in Delay Discounting (DD)

时间窗: Baseline; Week 6-8; Month 3; Month 6

A binary choice procedure will be conducted on a personal computer to assess relative preference for immediate versus delayed rewards.

次要结局

  • Change in Tower of Hanoi (ToH)(Baseline; Week 6-8; Month 3; Month 6)
  • Change in Iowa Gambling Task(Baseline; Week 6-8; Month 3; Month 6)
  • Change in Letter Numbering Sequencing (LTC)(Baseline; Week 6-8; Month 3; Month 6)
  • Change in Hopkins Verbal Learning Test(Baseline; Week 6-8; Month 3; Month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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