An Assessment of Cognitive Improvement Training Among Mid-life Individuals (RehabEF)

Kansas Board of Regents

Status: Enrolling

Conditions: Delay Discounting

Treatments: Behavioral: Verbal Memory--Visual; Behavioral: Sequenced Recall of Digits--Auditory; Behavioral: Sequenced Reverse Recall of Digits--Auditory; Behavioral: Sequenced Recall of Words--Visual

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03501706

STUDY00143274

7R01AG048904 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 680 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

680 participants in 2 patient groups

Active Training (AT) Group

Experimental group

Description:

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.

Treatment:

Behavioral: Sequenced Recall of Words--Visual

Behavioral: Sequenced Recall of Digits--Auditory

Behavioral: Verbal Memory--Visual

Behavioral: Sequenced Reverse Recall of Digits--Auditory

Control Training (CT) Group

No Intervention group

Description:

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.