- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03501706
An Assessment of Cognitive Improvement Training Among Mid-life Individuals (RehabEF)
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
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Richard Yi, PhD
- Phone Number: 785-864-6476
- Email: ryi1@ku.edu
Study Contact Backup
- Name: Anahi Collado, PhD
- Email: anco7407@colorado.edu
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21201
- Recruiting
- University of Kansas-Lawrence
-
Contact:
- Maggie Engstrom
- Email: maggie.engstrom@ku.edu
-
Principal Investigator:
- Richard Yi, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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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
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assessing abnormalties in lipids
|
Baseline; Week 6-8; Month 3; Month 6
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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
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Yi, PhD, University of Kansas
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00143274
- 7R01AG048904 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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