Delay DiscountingRehabEFNCT03501706
An Assessment of Cognitive Improvement Training Among Mid-life Individuals
A study testing Sequenced Recall of Digits--Auditory, Sequenced Reverse Recall of Digits--Auditory and Sequenced Recall of Words--Visual in people with Delay Discounting, run by University of Kansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Delay Discounting
- What is being tested?
- Sequenced Recall of Digits--Auditory, Sequenced Reverse Recall of Digits--Auditory and Sequenced Recall of Words--Visual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2014to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Community members in neighborhoods of Baltimore, Maryland
- Participants willing to participate in the 5-7 week program
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Anahi Collado, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Kansas-Lawrence
Baltimore, Maryland, 21201
Maggie Engstrom, maggie.engstrom@ku.edu
Richard Yi, PhD
About this study
Official title: 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.
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.
- Conditions
- Delay Discounting
- Being tested
- Sequenced Recall of Digits--Auditory, Sequenced Reverse Recall of Digits--Auditory, Sequenced Recall of Words--Visual, Verbal Memory--Visual
- Keywords
- intertemporal tradeoffs, delayed gratification, executive functioning, delay discounting, working memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequenced Recall of Digits--AuditoryBehavioural
Auditory digit sequence AT memory component.
Sequenced Reverse Recall of Digits--AuditoryBehavioural
Reversed auditory digit sequence AT memory component.
Sequenced Recall of Words--VisualBehavioural
Visual word sequence AT memory component
Verbal Memory--VisualBehavioural
word recognition AT memory component
| Study group | Role | What they receive |
|---|---|---|
| Active Training (AT) Group | Experimental | 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. Receives: Behavioral: Sequenced Recall of Digits--Auditory; Behavioral: Sequenced Reverse Recall of Digits--Auditory; Behavioral: Sequenced Recall of Words--Visual; Behavioral: Verbal Memory--Visual |
| Control Training (CT) Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; Week 6-8; Month 3; Month 6
Secondary outcomes (4)
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.
Measured: Baseline; Week 6-8; Month 3; Month 6
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.
Measured: Baseline; Week 6-8; Month 3; Month 6
Change in Tower of Hanoi (ToH)
Participants must move the stack of disks from one peg to another while following specific rules.
Measured: Baseline; Week 6-8; Month 3; Month 6
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.
Measured: Baseline; Week 6-8; Month 3; Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Nov 2014
- Primary completion31 May 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Delay DiscountingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore, University of Florida, Michigan State University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Richard Yi, PhD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501706
- Sponsor's protocol ID
- STUDY00143274
- Other IDs
- 7R01AG048904
- Acronym
- RehabEF
- Status last verified
- May 2024
- First submitted
- 9 Apr 2018
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share all de-identified data.
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 35018452Doran 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 33632921Felton 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
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remediation of Elevated Delay Discounting in Mid-life Individuals: A Stage-II Trial
- ClinicalTrials.gov ID
- NCT03501706
- Acronym / sponsor ID
- RehabEF / STUDY00143274
- Conditions
- Delay Discounting
- Keywords
- intertemporal tradeoffs, delayed gratification, executive functioning, delay discounting, working memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore, University of Florida, Michigan State University, National Institute on Aging (NIA)
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Training (AT) Group | Experimental | Behavioral: Sequenced Recall of Digits--Auditory, Behavioral: Sequenced Reverse Recall of Digits--Auditory, Behavioral: Sequenced Recall of Words--Visual, Behavioral: Verbal Memory--VisualParticipants 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. |
| Control Training (CT) Group | No intervention | –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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Community members in neighborhoods of Baltimore, Maryland
- Participants willing to participate in the 5-7 week program
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequenced Recall of Digits--AuditoryAuditory digit sequence AT memory component. | Behavioural | Active Training (AT) Group |
| Sequenced Reverse Recall of Digits--AuditoryReversed auditory digit sequence AT memory component. | Behavioural | Active Training (AT) Group |
| Sequenced Recall of Words--VisualVisual word sequence AT memory component | Behavioural | Active Training (AT) Group |
| Verbal Memory--Visualword recognition AT memory component | Behavioural | Active Training (AT) Group |
Primary outcome
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.
4 secondary outcomes
Change in Letter Numbering Sequencing (LTC)
Time frame: Baseline; Week 6-8; Month 3; Month 6
Change in Hopkins Verbal Learning Test
Time frame: Baseline; Week 6-8; Month 3; Month 6
Change in Tower of Hanoi (ToH)
Time frame: Baseline; Week 6-8; Month 3; Month 6
Change in Iowa Gambling Task
Time frame: Baseline; Week 6-8; Month 3; Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Derived from this study: PubMed 35018452Collado 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.
- Derived from this study: PubMed 33632921Doran 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.
- Derived from this study: PubMed 30955043Felton 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.
- Individual participant dataSharing planned: Yes. We will share all de-identified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anahi Collado, PhD contact
Richard Yi, PhD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequenced Recall of Digits--Auditory, Sequenced Reverse Recall of Digits--Auditory and Sequenced Recall of Words--Visual in people with Delay Discounting, run by University of Kansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Yi, PhD (785-864-6476, ryi1@ku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Delay Discounting (DD) (time frame: Baseline; Week 6-8; Month 3; Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03501706, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.