An Assessment of Cognitive Improvement Training Among Mid-life Individuals

Delay Discounting Clinical Trial

— RehabEF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03501706
• Other study ID #: STUDY00143274
• Secondary ID: 7R01AG048904
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2014
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: University of Kansas
• Contact: Richard Yi, PhD
• Phone: 785-864-6476
• Email: ryi1[@]ku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 680
• Est. completion date: July 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Delay Discounting

Intervention

Behavioral:
• Sequenced Recall of Digits--Auditory
Auditory digit sequence AT memory component.
• Sequenced Reverse Recall of Digits--Auditory
Reversed auditory digit sequence AT memory component.
• Sequenced Recall of Words--Visual
Visual word sequence AT memory component
• Verbal Memory--Visual
word recognition AT memory component

Locations

Country	Name	City	State
United States	University of Kansas-Lawrence	Baltimore	Maryland

Sponsors (5)

Lead Sponsor	Collaborator
University of Kansas	Michigan State University, National Institute on Aging (NIA), University of Florida, University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Timeline Follow-Back	Assess relevant point prevalence of alcohol/tobacco/drug use.	Baseline; Week 6-8; Month 3; Month 6
Other	Change in The Multidimensional Health Locus of Control	An 18-item questionnaire assessing the perception of the underlying causes of health outcomes events.	Baseline; Week 6-8; Month 3; Month 6
Other	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.	Baseline; Week 6-8; Month 3; Month 6
Other	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	Baseline; Week 6-8; Month 3; Month 6
Other	Change in Patient Activation Measure	Assesses how knowledgeable participants are about their health and how they can control it.	Baseline; Week 6-8; Month 3; Month 6
Other	Starting the Conversation: Diet Questionnaire	Assesses participants' diet	Baseline; Week 6-8; Month 3; Month 6
Other	Change in blood pressure	systolic and dystolic blood pressure	Baseline; Week 6-8; Month 3; Month 6
Other	Change in lipid profile	assessing abnormalties in lipids	Baseline; Week 6-8; Month 3; Month 6
Other	Change in body mass index	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
Other	Change in body expired carbon monoxide	expired carbon monoxide (parts per million), a measure of recent cigarette smoking	Baseline; Week 6-8; Month 3; Month 6
Other	Change in physical activity	International Physical Activity Questionnaire (IPAQ) self-reported physical activity assessment	Baseline; Week 6-8; Month 3; Month 6
Primary	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.	Baseline; Week 6-8; Month 3; Month 6
Secondary	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.	Baseline; Week 6-8; Month 3; Month 6
Secondary	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.	Baseline; Week 6-8; Month 3; Month 6
Secondary	Change in Tower of Hanoi (ToH)	Participants must move the stack of disks from one peg to another while following specific rules.	Baseline; Week 6-8; Month 3; Month 6
Secondary	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.	Baseline; Week 6-8; Month 3; Month 6