Clinical trial NCT03501706: An Assessment of Cognitive Improvement Training Among Mid-life Individuals
Official title: Remediation of Elevated Delay Discounting in Mid-life Individuals: A Stage-II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delay Discounting
Keywords: intertemporal tradeoffs
delayed gratification
executive functioning
delay discounting
working memory
Lead sponsor: University of Kansas
Sponsor class: OTHER
Collaborators: name: University of Maryland, Baltimore
name: University of Florida
name: Michigan State University
name: National Institute on Aging (NIA)
First posted: 2018-04-18
Enrollment: 680
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Delay Discounting (DD)
timeFrame: Baseline; Week 6-8; Month 3; Month 6
Secondary outcomes:
measure: Change in Letter Numbering Sequencing (LTC)
timeFrame: Baseline; Week 6-8; Month 3; Month 6
measure: Change in Hopkins Verbal Learning Test
timeFrame: Baseline; Week 6-8; Month 3; Month 6
measure: Change in Tower of Hanoi (ToH)
timeFrame: Baseline; Week 6-8; Month 3; Month 6
measure: Change in Iowa Gambling Task
timeFrame: Baseline; Week 6-8; Month 3; Month 6
Other outcomes:
measure: Change in Timeline Follow-Back
timeFrame: Baseline; Week 6-8; Month 3; Month 6
measure: Change in The Multidimensional Health Locus of Control
timeFrame: Baseline; Week 6-8; Month 3; Month 6
measure: Change in Chernyshenko Conscientiousness Scale (CCS)
timeFrame: Baseline; Week 6-8; Month 3; Month 6
measure: Resource Utilization Measure
timeFrame: Baseline; Week 6-8; Month 3; Month 6
measure: Change in Patient Activation Measure
timeFrame: Baseline; Week 6-8; Month 3; Month 6
measure: Starting the Conversation: Diet Questionnaire
timeFrame: Baseline; Week 6-8; Month 3; Month 6
measure: Change in blood pressure
timeFrame: Baseline; Week 6-8; Month 3; Month 6
measure: Change in lipid profile
timeFrame: Baseline; Week 6-8; Month 3; Month 6
measure: Change in body mass index
timeFrame: Baseline; Week 6-8; Month 3; Month 6
measure: Change in body expired carbon monoxide
timeFrame: Baseline; Week 6-8; Month 3; Month 6
measure: Change in physical activity
timeFrame: Baseline; Week 6-8; Month 3; Month 6
Locations:
city: Baltimore
country: United States
facility: University of Kansas-Lawrence
state: Maryland
Study officials:
affiliation: University of Kansas
name: Richard Yi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collado A, Felton J, Grunevski S, Doran K, Yi R. Working Memory Training Reduces Cigarette Smoking Among Low-Income Individuals With Elevated Delay Discounting. Nicotine Tob Res. 2022 Apr 28;24(6):890-896. doi: 10.1093/ntr/ntac005.
citation: Doran K, Collado A, Taylor H, Felton JW, Tormohlen KN, Yi R. Methods to Optimize Recruitment, Participation, and Retention Among Vulnerable Individuals Participating in a Longitudinal Clinical Trial. Res Theory Nurs Pract. 2021 Feb 1;35(1):24-49. doi: 10.1891/RTNP-D-19-00039.
citation: Felton JW, Collado A, Ingram KM, Doran K, Yi R. Improvement of Working Memory is a Mechanism for Reductions in Delay Discounting Among Mid-Age Individuals in an Urban Medically Underserved Area. Ann Behav Med. 2019 Oct 7;53(11):988-998. doi: 10.1093/abm/kaz010.