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An Assessment of Cognitive Improvement Training Among Mid-life Individuals

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03501706
Acronym
RehabEF
Enrollment
680
Registered
2018-04-18
Start date
2014-11-01
Completion date
2024-07-31
Last updated
2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delay Discounting

Keywords

intertemporal tradeoffs, delayed gratification, executive functioning, delay discounting, working memory

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.

Interventions

BEHAVIORALSequenced Recall of Digits--Auditory

Auditory digit sequence AT memory component.

BEHAVIORALSequenced Reverse Recall of Digits--Auditory

Reversed auditory digit sequence AT memory component.

BEHAVIORALSequenced Recall of Words--Visual

Visual word sequence AT memory component

BEHAVIORALVerbal Memory--Visual

word recognition AT memory component

Sponsors

University of Maryland, Baltimore
CollaboratorOTHER
University of Florida
CollaboratorOTHER
Michigan State University
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
University of Kansas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in Letter Numbering Sequencing (LTC)Baseline; Week 6-8; Month 3; Month 6The 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.
Change in Hopkins Verbal Learning TestBaseline; Week 6-8; Month 3; Month 6Participants 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.
Change in Tower of Hanoi (ToH)Baseline; Week 6-8; Month 3; Month 6Participants must move the stack of disks from one peg to another while following specific rules.
Change in Iowa Gambling TaskBaseline; Week 6-8; Month 3; Month 6Participants 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.

Other

MeasureTime frameDescription
Starting the Conversation: Diet QuestionnaireBaseline; Week 6-8; Month 3; Month 6Assesses participants' diet
Change in blood pressureBaseline; Week 6-8; Month 3; Month 6systolic and dystolic blood pressure
Change in lipid profileBaseline; Week 6-8; Month 3; Month 6assessing abnormalties in lipids
Change in Timeline Follow-BackBaseline; Week 6-8; Month 3; Month 6Assess relevant point prevalence of alcohol/tobacco/drug use.
Change in body expired carbon monoxideBaseline; Week 6-8; Month 3; Month 6expired carbon monoxide (parts per million), a measure of recent cigarette smoking
Change in physical activityBaseline; Week 6-8; Month 3; Month 6International Physical Activity Questionnaire (IPAQ) self-reported physical activity assessment
Change in body mass indexBaseline; Week 6-8; Month 3; Month 6body mass index, a ratio of weight (kg) and height (m) will be calculated as kg/m\^2
Change in The Multidimensional Health Locus of ControlBaseline; Week 6-8; Month 3; Month 6An 18-item questionnaire assessing the perception of the underlying causes of health outcomes events.
Change in Chernyshenko Conscientiousness Scale (CCS)Baseline; Week 6-8; Month 3; Month 6CCS is used to assess six facets of conscientiousness, ranking them on a scale of 1-4 with 4 being strongly agree.
Resource Utilization MeasureBaseline; Week 6-8; Month 3; Month 6Addresses if individuals accessed healthcare providers in the past thirty days, including visits to doctor's offices or seeing a mental health professional
Change in Patient Activation MeasureBaseline; Week 6-8; Month 3; Month 6Assesses how knowledgeable participants are about their health and how they can control it.

Countries

United States

Contacts

Primary ContactRichard Yi, PhD
ryi1@ku.edu785-864-6476
Backup ContactAnahi Collado, PhD
anco7407@colorado.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026