An Assessment of Cognitive Improvement Training Among Mid-life Individuals (RehabEF)

January 25, 2024 updated by: University of Kansas

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

680

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Richard Yi, PhD
  • Phone Number: 785-864-6476
  • Email: ryi1@ku.edu

Study Contact Backup

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Kansas-Lawrence
        • Contact:
        • Principal Investigator:
          • Richard Yi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Auditory digit sequence AT memory component.
Reversed auditory digit sequence AT memory component.
Visual word sequence AT memory component
word recognition AT memory component
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Delay Discounting (DD)
Time Frame: 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.
Baseline; Week 6-8; Month 3; Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Letter Numbering Sequencing (LTC)
Time Frame: Baseline; Week 6-8; Month 3; Month 6
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
Time Frame: Baseline; Week 6-8; Month 3; Month 6
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)
Time Frame: Baseline; Week 6-8; Month 3; Month 6
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
Time Frame: Baseline; Week 6-8; Month 3; Month 6
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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard Yi, PhD, University of Kansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00143274
  • 7R01AG048904 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share all de-identified data.

IPD Sharing Time Frame

One year following publication of the primary outcomes.

IPD Sharing Access Criteria

Inquiry with PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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