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RecruitingNCT03501706RehabEFUpdated May 10, 2024

An Assessment of Cognitive Improvement Training Among Mid-life Individuals

An interventional study of Sequenced Recall of Digits--Auditory and Sequenced Reverse Recall of Digits--Auditory in Delay Discounting, sponsored by University of Kansas. Recruiting at 1 site in United States. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-10.

Sponsored by University of Kansas · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
680
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Delay Discounting

Keywords

  • intertemporal tradeoffs
  • delayed gratification
  • executive functioning
  • delay discounting
  • working memory
03

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
680 participants (estimated)

Study arms

  • Experimental
    Active Training (AT) Group

    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 · Behavioral: Sequenced Reverse Recall of Digits--Auditory · Behavioral: Sequenced Recall of Words--Visual · Behavioral: Verbal Memory--Visual

  • No intervention
    Control Training (CT) Group

    Participants will complete the four computerized programs relating to executive function (EF), but will be provided with the answer (i.e., without memory requirements). That is, participants in the control condition will not be asked to engage their cognitive functions.

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline; Week 6-8; Month 3; Month 6

Secondary outcomes

  1. 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.

    Time frame: Baseline; Week 6-8; Month 3; Month 6

  2. 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.

    Time frame: Baseline; Week 6-8; Month 3; Month 6

  3. Change in Tower of Hanoi (ToH)

    Participants must move the stack of disks from one peg to another while following specific rules.

    Time frame: Baseline; Week 6-8; Month 3; Month 6

  4. 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.

    Time frame: Baseline; Week 6-8; Month 3; Month 6

Other outcomes

  1. Change in Timeline Follow-Back

    Assess relevant point prevalence of alcohol/tobacco/drug use.

    Time frame: Baseline; Week 6-8; Month 3; Month 6

  2. Change in The Multidimensional Health Locus of Control

    An 18-item questionnaire assessing the perception of the underlying causes of health outcomes events.

    Time frame: Baseline; Week 6-8; Month 3; Month 6

  3. Change in Chernyshenko Conscientiousness Scale (CCS)

    CCS is used to assess six facets of conscientiousness, ranking them on a scale of 1-4 with 4 being strongly agree.

    Time frame: Baseline; Week 6-8; Month 3; Month 6

  4. Resource Utilization Measure

    Addresses if individuals accessed healthcare providers in the past thirty days, including visits to doctor's offices or seeing a mental health professional

    Time frame: Baseline; Week 6-8; Month 3; Month 6

  5. Change in Patient Activation Measure

    Assesses how knowledgeable participants are about their health and how they can control it.

    Time frame: Baseline; Week 6-8; Month 3; Month 6

  6. Starting the Conversation: Diet Questionnaire

    Assesses participants' diet

    Time frame: Baseline; Week 6-8; Month 3; Month 6

  7. Change in blood pressure

    systolic and dystolic blood pressure

    Time frame: Baseline; Week 6-8; Month 3; Month 6

  8. Change in lipid profile

    assessing abnormalties in lipids

    Time frame: Baseline; Week 6-8; Month 3; Month 6

  9. Change in body mass index

    body mass index, a ratio of weight (kg) and height (m) will be calculated as kg/m\^2

    Time frame: Baseline; Week 6-8; Month 3; Month 6

  10. Change in body expired carbon monoxide

    expired carbon monoxide (parts per million), a measure of recent cigarette smoking

    Time frame: Baseline; Week 6-8; Month 3; Month 6

  11. Change in physical activity

    International Physical Activity Questionnaire (IPAQ) self-reported physical activity assessment

    Time frame: Baseline; Week 6-8; Month 3; Month 6

06

Study locations

1 of 1 sites recruiting
  • University of Kansas-Lawrence
    Baltimore, Maryland 21201, United States
    Recruiting
07

References and documents

Publications

  • 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. PubMed 35018452 ↗
  • 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. PubMed 33632921 ↗
  • 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. PubMed 30955043 ↗

Individual participant data

Plan to share: Yes — We will share all de-identified data.

Supporting information: Study protocol, Sap, Icf

08

Registry details

Key details

Study ID
NCT03501706
Lead sponsor
University of Kansas
Collaborators
University of Maryland, Baltimore, University of Florida, Michigan State University, National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Apr 18, 2018
Start date
Nov 1, 2014
Primary completion
May 31, 2024 (estimated)
Completion
Jul 31, 2024 (estimated)
Last update
May 10, 2024

Study contacts

Richard Yi, PhD
Contact
ryi1@ku.edu
785-864-6476
Anahi Collado, PhD
Contact
anco7407@colorado.edu
Richard Yi, PhD
principal investigator · University of Kansas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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