An interventional study of Sequenced Recall of Digits--Auditory and Sequenced Reverse Recall of Digits--Auditory in Delay Discounting, sponsored by University of Kansas. Recruiting at 1 site in United States. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by University of Kansas · Not applicable, Interventional, and Treatment
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.
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.
University of Kansas is the lead sponsor of 81 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Sequenced Recall of Digits--Auditory · Behavioral: Sequenced Reverse Recall of Digits--Auditory · Behavioral: Sequenced Recall of Words--Visual · Behavioral: Verbal Memory--Visual
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.
Auditory digit sequence AT memory component.
Reversed auditory digit sequence AT memory component.
Visual word sequence AT memory component
word recognition AT memory component
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.
Time frame: Baseline; Week 6-8; Month 3; Month 6
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; Week 6-8; Month 3; Month 6
Change in Timeline Follow-Back
Assess relevant point prevalence of alcohol/tobacco/drug use.
Time frame: Baseline; Week 6-8; Month 3; Month 6
Change in The Multidimensional Health Locus of Control
An 18-item questionnaire assessing the perception of the underlying causes of health outcomes events.
Time frame: Baseline; Week 6-8; Month 3; Month 6
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.
Time frame: Baseline; Week 6-8; Month 3; Month 6
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
Time frame: Baseline; Week 6-8; Month 3; Month 6
Change in Patient Activation Measure
Assesses how knowledgeable participants are about their health and how they can control it.
Time frame: Baseline; Week 6-8; Month 3; Month 6
Starting the Conversation: Diet Questionnaire
Assesses participants' diet
Time frame: Baseline; Week 6-8; Month 3; Month 6
Change in blood pressure
systolic and dystolic blood pressure
Time frame: Baseline; Week 6-8; Month 3; Month 6
Change in lipid profile
assessing abnormalties in lipids
Time frame: Baseline; Week 6-8; Month 3; Month 6
Change in body mass index
body mass index, a ratio of weight (kg) and height (m) will be calculated as kg/m\^2
Time frame: Baseline; Week 6-8; Month 3; Month 6
Change in body expired carbon monoxide
expired carbon monoxide (parts per million), a measure of recent cigarette smoking
Time frame: Baseline; Week 6-8; Month 3; Month 6
Change in physical activity
International Physical Activity Questionnaire (IPAQ) self-reported physical activity assessment
Time frame: Baseline; Week 6-8; Month 3; Month 6
Plan to share: Yes — We will share all de-identified data.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: One year following publication of the primary outcomes.
Access criteria: Inquiry with PI
Started Nov 2014 (actual). Primary completion is estimated for May 2024, 114 months after the start.
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