An Assessment of Cognitive Improvement Training Among Mid-life Individuals

NCT ID: NCT03501706

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

680 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-01

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Delay Discounting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Sequenced Recall of Digits--Auditory

Intervention Type BEHAVIORAL

Auditory digit sequence AT memory component.

Sequenced Reverse Recall of Digits--Auditory

Intervention Type BEHAVIORAL

Reversed auditory digit sequence AT memory component.

Sequenced Recall of Words--Visual

Intervention Type BEHAVIORAL

Visual word sequence AT memory component

Verbal Memory--Visual

Intervention Type BEHAVIORAL

word recognition AT memory component

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sequenced Recall of Digits--Auditory

Auditory digit sequence AT memory component.

Intervention Type BEHAVIORAL

Sequenced Reverse Recall of Digits--Auditory

Reversed auditory digit sequence AT memory component.

Intervention Type BEHAVIORAL

Sequenced Recall of Words--Visual

Visual word sequence AT memory component

Intervention Type BEHAVIORAL

Verbal Memory--Visual

word recognition AT memory component

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Maryland, Baltimore

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Kansas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard Yi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Kansas-Lawrence

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Richard Yi, PhD

Role: CONTACT

785-864-6476

Anahi Collado, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Maggie Engstrom

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35018452 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33632921 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30955043 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

7R01AG048904

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00143274

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Everyday Memory Intervention
NCT04088136 COMPLETED NA