An Assessment of Cognitive Improvement Training Among Mid-life Individuals

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Delay Discounting

Intervention / Treatment
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* Behavioral: Sequenced Recall of Digits--Auditory
* Behavioral: Sequenced Reverse Recall of Digits--Auditory
* Behavioral: Sequenced Recall of Words--Visual
* Behavioral: Verbal Memory--Visual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: community members in neighborhoods of Baltimore, Maryland participants willing to participate in the 5-7 week program Exclusion Criteria: participants cannot have a severe substance use disorder according to the DSM-V 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Training (AT) Group<br>Participants will complete four computerized training programs to improve executive function (EF), including Sequenced Recall of Digits - Auditory, Sequenced Reverse Recall of Digits - Auditory, Sequenced Recall of Words - Visual, Verbal Memory - Visual. | Behavioral: Sequenced Recall of Digits--Auditory<br>* Auditory digit sequence AT memory component.<br>Behavioral: Sequenced Reverse Recall of Digits--Auditory<br>* Reversed auditory digit sequence AT memory component.<br>Behavioral: Sequenced Recall of Words--Visual<br>* Visual word sequence AT memory component<br>Behavioral: Verbal Memory--Visual<br>* word recognition AT memory component<br>|
| No Intervention: Control Training (CT) Group<br>Participants will complete the four computerized programs relating to executive function (EF), but without memory requirements for control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Delay Discounting (DD) | A binary choice procedure will be conducted on a personal computer to assess relative preference for immediate versus delayed rewards. | Baseline; Week 6-8; Month 3; Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Letter Numbering Sequencing (LTC) | The participant is given a mixed string of letters and numbers that must then be put into a sequential order of numbers followed by a sequential order of letters. | Baseline; Week 6-8; Month 3; Month 6 | 
| Change in Hopkins Verbal Learning Test | Participants memorize a list of words presented auditorily, then are asked to recall or recognize as many words as possible, either immediately or following a delay. | Baseline; Week 6-8; Month 3; Month 6 | 
| Change in Tower of Hanoi (ToH) | Participants must move the stack of disks from one peg to another while following specific rules. | Baseline; Week 6-8; Month 3; Month 6 | 
| Change in Iowa Gambling Task | Participants are asked to choose to flip cards from one of 4 decks, where each deck is associated with a specific probability of winning and losing some money. | Baseline; Week 6-8; Month 3; Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intertemporal tradeoffs, delayed gratification, executive functioning, delay discounting, working memory