PreDiabetesMINDDNCT03664726
MINDD 3: Prediabetes and Delay Discounting
A study testing Episodic Future Thinking, Episodic Recent Thinking and Scarcity Narrative in people with PreDiabetes, run by Leonard Epstein at 2 sites in United States.
Trial summary
The proposed research will translate research on delay discounting to the prevention of Type 2 diabetes (T2D) in persons with prediabetes. In this study, the investigators will verify target engagement (DD) by examining if EFT improves DD under conditions shown to increase discounting of the future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Episodic Future Thinking, Episodic Recent Thinking and Scarcity Narrative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prediabetes: Participants must have a diagnosis of prediabetes within the last 2 years or meet criteria for prediabetes. The American Diabetes Association guidelines defines prediabetes as Fasting Plasma Glucose (FPG) 100-125 mg/dl, 2h glucose 140-199 mg/dl after Oral Glucose Tolerance Test (OGTT), or hemoglobin A1c (HbA1c) approximately 5.7-6.4%.
- Comorbidities: Participants must have a history of comorbid diagnosis such as hypertension and/or hyperlipidemia to participate in the behavioral portion of this study. Hypertension is defined as blood pressure greater than 140/90 on two separate occasions at least one week apart, or medical management for hypertension (i.e. medications including Lisinopril and Diovan). Dyslipidemia is defined by LDL greater than 130 mg/dl, or non-fasting non HDL cholesterol ≥160mg/dL or medical management for dyslipidemia (medications including Niacin, Lovastatin).
Who cannot join
- Type 2 Diabetes: Individuals will be excluded if they have Type 2 Diabetes.
- Pregnancy: Women who are pregnant or lactating will be excluded from participation.
- Conditions that affect adherence: Participants should not have a condition that would limit participation which include medical conditions that would affect individuals' ability to use the computer for prolonged period of time; leave the individual unable to ambulate; or current diagnoses of an eating disorder (anorexia, bulimia,), unmanaged psychiatric disorder (depression, anxiety, attention deficit hyperactivity disorder (ADHD), schizophrenia), or an intellectual impairment that would impact study adherence.
- Abnormal glucose related to medications: Participants should not be taking medications that would limit participation and cause abnormal glucose levels (e.g. atypical antipsychotic medications or glucocorticoids) including diabetic drugs such as Metformin.
- Unwilling or unable to eat study food: Participants who are unwilling or not able to eat the study food (a PowerBar) will not be able to take part in this study.
- Prior participation in similar studies: Individuals who have recently participated in a laboratory study using similar methods may also be excluded.
- Do not meet discounting criteria: Individuals who do not meet discounting criteria (e.g. nonsystematic discounting) on a delay discounting task may be excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine
Buffalo, New York, 14214
Fralin Biomedical Research Institute, Virginia Tech Carilion
Roanoke, Virginia, 24016
About this study
Official title: Delay Discounting as a Target for Self-Regulation in Prediabetes
The proposed research will translate research on delay discounting to the prevention of Type 2 diabetes (T2D) in persons with prediabetes. In this study, the investigators will verify target engagement (DD) by examining if EFT improves DD under conditions shown to increase discounting of the future. Prediabetics will be randomized to receive EFT/ERT in a factorial design when experiencing simulated poverty/neutral conditions, respectively. The effects will be measured on DD. The investigators predict that poverty conditions will increase discounting of the future for ERT subjects, but those receiving EFT will show levels of DD similar to levels observed for participants in the wealth condition.
Read the detailed description
The prevention of Type 2 diabetes in an obese person with prediabetes requires developing a healthier lifestyle. The rational approach for someone with prediabetes would be to eat healthier, be more active, lose weight, and manage their comorbidities. However, preliminary research suggests that individuals with Type 2 diabetes discount the future and engage in behaviors that maximize current pleasure and short-term gain; thus, daily choices needed to improve future health are rare in this population. Delay discounting (DD) describes the choice of smaller immediate versus larger delayed rewards. This behavioral process is related to a wide variety of health choices, ranging from preventive health to behavioral and medical regimen adherence, including regimens used for Type 2 diabetes. The investigators believe that DD provides a target for one type of self-regulation that can improve a wide variety of health behaviors and medical adherence.
Research from our laboratories has shown that episodic future thinking (EFT), a form of prospection which reduces the bias towards immediate gratification, activates brain regions involved in planning and prospection such that future rewards have increased value and the extent of delay discounting is reduced. Cueing individuals to think about future events during inter-temporal decision-making reduces the rate of DD, eating in and outside of the laboratory, and smoking behavior. The overarching goal of this research is to use an experimental medicine approach to translate basic research on DD and EFT into clinical interventions to prevent the transition from prediabetes to a diagnosis of Type 2 diabetes.
- Conditions
- PreDiabetes
- Being tested
- Episodic Future Thinking, Episodic Recent Thinking, Scarcity Narrative, Neutral Narrative
- Keywords
- Delay Discounting, Episodic Future Thinking
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episodic Future ThinkingBehavioural
Also called EFT
Participants will be instructed to use their episodic future cues as they engage in different decision making tasks.
Episodic Recent ThinkingBehavioural
Also called ERT
Participants will be instructed to use their episodic recent cues as they engage in different decision making tasks.
Scarcity NarrativeBehavioural
Also called Scarcity
Participants will read a narrative to induce a scarcity mindset, in which they are asked to imagine a scenario in which they have lost their job and have no current secondary income.
Neutral NarrativeBehavioural
Also called Neutral
Participants will read a narrative in which they are asked to imagine a scenario in which they have been transferred between departmental jobs, with little change in salary/commute.
| Study group | Role | What they receive |
|---|---|---|
| Episodic Future Thinking (EFT) & Neutral Narrative | Experimental | Participants will complete an episodic thinking task to generate episodic cues where they will list and describe events for different time periods.The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event (e.g., vacations, weddings, parties, and so forth). EFT participants will list positive future events they are looking forward to and list events that could happen at different general future time points (e.g., 1 month, 2-6 months, 7-12 months). Participants will also be asked to think about a neutral narrative that describes a situation in which changes to their income are neutral or minimal Receives: Behavioral: Episodic Future Thinking; Behavioral: Neutral Narrative |
| Episodic Recent Thinking (ERT) & Neutral Narrative | Active comparator | Participants will complete an episodic recent thinking task to generate episodic cues where they will list and describe events for different time periods. The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event. ERT participants will list positive recent events they enjoyed and list events that happened recently (e.g. 1 - 7 days ago). Participants will also be asked to think about a neutral narrative that describes a situation in which changes to their income are neutral or minimal (e.g. department job transfer). Receives: Behavioral: Episodic Recent Thinking; Behavioral: Neutral Narrative |
| Episodic Future Thinking (EFT) & Scarcity Narrative | Experimental | Participants will complete an episodic thinking task to generate episodic cues where they will list and describe events for different time periods.The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event (e.g., vacations, weddings, parties, and so forth). EFT participants will list positive future events they are looking forward to and list events that could happen at different general future time points (e.g., 1 month, 2-6 months, 7-12 months). Participants will also be asked to think about a narrative to induce a scarcity mindset by describing a situation in which changes to their income are negative (e.g. loss of job). Receives: Behavioral: Episodic Future Thinking; Behavioral: Scarcity Narrative |
| Episodic Recent Thinking (ERT) & Scarcity Narrative | Experimental | Participants will complete an episodic recent thinking task to generate episodic cues where they will list and describe events for different time periods. The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event. ERT participants will list positive recent events they enjoyed and list events that happened recently (e.g. 1 - 7 days ago). Participants will also be asked to think about a narrative to induce a scarcity mindset by describing a situation in which changes to their income are negative (e.g. loss of job). Receives: Behavioral: Episodic Recent Thinking; Behavioral: Scarcity Narrative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Delay Discounting
Delay Discounting will be measured using monetary Delay Discounting tasks with $100 as the delayed reward. Delay discounting is assessed using Area Under the Curve (AUC), or time*indifference point/delay. AUC for delay discounting included time (x-axis) and indifference point (y-axis), or the amount of money at which the immediate and delayed options are approximately equal. Indifference points are a percentage of the max amount (range 0 - 100). AUC adds the calculated areas for each timepoint from the previous timepoint. Ordinal AUC was used as the measure. Ordinal AUC normalizes the horizontal axis time points to have equal distances between them. AUC ranges from 0 (most impulsive, did not choose delay) to 100 (least impulsive, always chose delay).
This is the difference in delay discounting between session 2 and session 1. Larger numbers indicate a decrease in discounting, or less impulsive, while smaller/negative numbers indicate an increase in discounting, or more impulsive.
Measured: Delay Discounting will be measured at baseline (session 1) and after receiving EFT/ERT and Scarcity/Narrative (within about 2 weeks)
Reinforcing Value of Food
Reinforcing value of food was measured using the relative reinforcing efficacy questionnaire in which participants are asked how many portions of food they would purchase at various prices. Intensity is the number of portions they would purchase and consume when the price is $0.
Measured: Session 2
Secondary outcomes (1)
Change in Working Memory Span
Backwards Corsi is a task that assesses visuo-spatial short term working memory. Participants are asked to watch a series of squares on a computer screen and repeat the sequence backwards. This is done several times and the highest number of correctly remembered locations is the span score, with a possible score of 2 - 9 locations total. Span score represents the number of locations that can be recalled backwards. Larger span scores indicate more locations can be remembered and recalled correctly backwards. This is the difference in score between session 2 and session 1. Larger numbers indicate greater change during the experimental manipulation or better working memory, while smaller or negative numbers indicates lower working memory during the experimental manipulation versus baseline. Numbers close to 0 represent little to no change.
Measured: Working Memory will be measured at baseline (session 1) and after receiving EFT/ERT Scarcity/Neutral intervention (up to 2 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start12 Feb 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants will be assigned to complete an episodic future or recent thinking task and asked to describe positive events for different time periods.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leonard Epstein
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Sponsor-investigator, Leonard Epstein, State University of New York at Buffalo
- Investigators
- Leonard H Epstein, Principal investigator, SUNY University at BuffaloWarren K Bickel, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664726
- Sponsor's protocol ID
- UH2DK109543-02
- Acronym
- MINDD
- Status last verified
- Feb 2023
- First submitted
- 4 Apr 2018
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available
Publications
Stein JS, Craft WH, Paluch RA, Gatchalian KM, Greenawald MH, Quattrin T, Mastrandrea LD, Epstein LH, Bickel WK. Bleak present, bright future: II. Combined effects of episodic future thinking and scarcity on delay discounting in adults at risk for type 2 diabetes. J Behav Med. 2021 Apr;44(2):222-230. doi: 10.1007/s10865-020-00178-7. Epub 2020 Sep 28.
PubMed 32989616Bickel WK, Stein JS, Paluch RA, Mellis AM, Athamneh LN, Quattrin T, Greenawald MH, Bree KA, Gatchalian KM, Mastrandrea LD, Epstein LH. Does Episodic Future Thinking Repair Immediacy Bias at Home and in the Laboratory in Patients With Prediabetes? Psychosom Med. 2020 Sep;82(7):699-707. doi: 10.1097/PSY.0000000000000841.
PubMed 32868537
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delay Discounting as a Target for Self-Regulation in Prediabetes
- ClinicalTrials.gov ID
- NCT03664726
- Acronym / sponsor ID
- MINDD / UH2DK109543-02
- Conditions
- PreDiabetes
- Keywords
- Delay Discounting, Episodic Future Thinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Leonard EpsteinUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Posted 4 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research will translate research on delay discounting to the prevention of Type 2 diabetes (T2D) in persons with prediabetes. In this study, the investigators will verify target engagement (DD) by examining if EFT improves DD under conditions shown to increase discounting of the future. Prediabetics will be randomized to receive EFT/ERT in a factorial design when experiencing simulated poverty/neutral conditions, respectively. The effects will be measured on DD. The investigators predict that poverty conditions will increase discounting of the future for ERT subjects, but those receiving EFT will show levels of DD similar to levels observed for participants in the wealth condition.
Detailed description
The prevention of Type 2 diabetes in an obese person with prediabetes requires developing a healthier lifestyle. The rational approach for someone with prediabetes would be to eat healthier, be more active, lose weight, and manage their comorbidities. However, preliminary research suggests that individuals with Type 2 diabetes discount the future and engage in behaviors that maximize current pleasure and short-term gain; thus, daily choices needed to improve future health are rare in this population. Delay discounting (DD) describes the choice of smaller immediate versus larger delayed rewards. This behavioral process is related to a wide variety of health choices, ranging from preventive health to behavioral and medical regimen adherence, including regimens used for Type 2 diabetes. The investigators believe that DD provides a target for one type of self-regulation that can improve a wide variety of health behaviors and medical adherence.
Research from our laboratories has shown that episodic future thinking (EFT), a form of prospection which reduces the bias towards immediate gratification, activates brain regions involved in planning and prospection such that future rewards have increased value and the extent of delay discounting is reduced. Cueing individuals to think about future events during inter-temporal decision-making reduces the rate of DD, eating in and outside of the laboratory, and smoking behavior. The overarching goal of this research is to use an experimental medicine approach to translate basic research on DD and EFT into clinical interventions to prevent the transition from prediabetes to a diagnosis of Type 2 diabetes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be assigned to complete an episodic future or recent thinking task and asked to describe positive events for different time periods.
| Arm | Type | Receives |
|---|---|---|
| Episodic Future Thinking (EFT) & Neutral Narrative | Experimental | Behavioral: Episodic Future Thinking, Behavioral: Neutral NarrativeParticipants will complete an episodic thinking task to generate episodic cues where they will list and describe events for different time periods.The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event (e.g., vacations, weddings, parties, and so forth). EFT participants will list positive future events they are looking forward to and list events that could happen at different general future time points (e.g., 1 month, 2-6 months, 7-12 months). Participants will also be asked to think about a neutral narrative that describes a situation in which changes to their income are neutral or minimal |
| Episodic Recent Thinking (ERT) & Neutral Narrative | Active comparator | Behavioral: Episodic Recent Thinking, Behavioral: Neutral NarrativeParticipants will complete an episodic recent thinking task to generate episodic cues where they will list and describe events for different time periods. The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event. ERT participants will list positive recent events they enjoyed and list events that happened recently (e.g. 1 - 7 days ago). Participants will also be asked to think about a neutral narrative that describes a situation in which changes to their income are neutral or minimal (e.g. department job transfer). |
| Episodic Future Thinking (EFT) & Scarcity Narrative | Experimental | Behavioral: Episodic Future Thinking, Behavioral: Scarcity NarrativeParticipants will complete an episodic thinking task to generate episodic cues where they will list and describe events for different time periods.The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event (e.g., vacations, weddings, parties, and so forth). EFT participants will list positive future events they are looking forward to and list events that could happen at different general future time points (e.g., 1 month, 2-6 months, 7-12 months). Participants will also be asked to think about a narrative to induce a scarcity mindset by describing a situation in which changes to their income are negative (e.g. loss of job). |
| Episodic Recent Thinking (ERT) & Scarcity Narrative | Experimental | Behavioral: Episodic Recent Thinking, Behavioral: Scarcity NarrativeParticipants will complete an episodic recent thinking task to generate episodic cues where they will list and describe events for different time periods. The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event. ERT participants will list positive recent events they enjoyed and list events that happened recently (e.g. 1 - 7 days ago). Participants will also be asked to think about a narrative to induce a scarcity mindset by describing a situation in which changes to their income are negative (e.g. loss of job). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prediabetes: Participants must have a diagnosis of prediabetes within the last 2 years or meet criteria for prediabetes. The American Diabetes Association guidelines defines prediabetes as Fasting Plasma Glucose (FPG) 100-125 mg/dl, 2h glucose 140-199 mg/dl after Oral Glucose Tolerance Test (OGTT), or hemoglobin A1c (HbA1c) approximately 5.7-6.4%.
- Comorbidities: Participants must have a history of comorbid diagnosis such as hypertension and/or hyperlipidemia to participate in the behavioral portion of this study. Hypertension is defined as blood pressure greater than 140/90 on two separate occasions at least one week apart, or medical management for hypertension (i.e. medications including Lisinopril and Diovan). Dyslipidemia is defined by LDL greater than 130 mg/dl, or non-fasting non HDL cholesterol ≥160mg/dL or medical management for dyslipidemia (medications including Niacin, Lovastatin).
Key exclusion criteria (7 listed)
- Type 2 Diabetes: Individuals will be excluded if they have Type 2 Diabetes.
- Pregnancy: Women who are pregnant or lactating will be excluded from participation.
- Conditions that affect adherence: Participants should not have a condition that would limit participation which include medical conditions that would affect individuals' ability to use the computer for prolonged period of time; leave the individual unable to ambulate; or current diagnoses of an eating disorder (anorexia, bulimia,), unmanaged psychiatric disorder (depression, anxiety, attention deficit hyperactivity disorder (ADHD), schizophrenia), or an intellectual impairment that would impact study adherence.
- Abnormal glucose related to medications: Participants should not be taking medications that would limit participation and cause abnormal glucose levels (e.g. atypical antipsychotic medications or glucocorticoids) including diabetic drugs such as Metformin.
- Unwilling or unable to eat study food: Participants who are unwilling or not able to eat the study food (a PowerBar) will not be able to take part in this study.
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 |
|---|---|---|
| Episodic Future ThinkingAlso: EFTParticipants will be instructed to use their episodic future cues as they engage in different decision making tasks. | Behavioural | Episodic Future Thinking (EFT) & Neutral Narrative, Episodic Future Thinking (EFT) & Scarcity Narrative |
| Episodic Recent ThinkingAlso: ERTParticipants will be instructed to use their episodic recent cues as they engage in different decision making tasks. | Behavioural | Episodic Recent Thinking (ERT) & Neutral Narrative, Episodic Recent Thinking (ERT) & Scarcity Narrative |
| Scarcity NarrativeAlso: ScarcityParticipants will read a narrative to induce a scarcity mindset, in which they are asked to imagine a scenario in which they have lost their job and have no current secondary income. | Behavioural | Episodic Future Thinking (EFT) & Scarcity Narrative, Episodic Recent Thinking (ERT) & Scarcity Narrative |
| Neutral NarrativeAlso: NeutralParticipants will read a narrative in which they are asked to imagine a scenario in which they have been transferred between departmental jobs, with little change in salary/commute. | Behavioural | Episodic Future Thinking (EFT) & Neutral Narrative, Episodic Recent Thinking (ERT) & Neutral Narrative |
Primary outcome
Change in Delay Discounting
Time frame: Delay Discounting will be measured at baseline (session 1) and after receiving EFT/ERT and Scarcity/Narrative (within about 2 weeks)
Delay Discounting will be measured using monetary Delay Discounting tasks with $100 as the delayed reward. Delay discounting is assessed using Area Under the Curve (AUC), or time*indifference point/delay. AUC for delay discounting included time (x-axis) and indifference point (y-axis), or the amount of money at which the immediate and delayed options are approximately equal. Indifference points are a percentage of the max amount (range 0 - 100). AUC adds the calculated areas for each timepoint from the previous timepoint. Ordinal AUC was used as the measure. Ordinal AUC normalizes the horizontal axis time points to have equal distances between them. AUC ranges from 0 (most impulsive, did not choose delay) to 100 (least impulsive, always chose delay). This is the difference in delay discounting between session 2 and session 1. Larger numbers indicate a decrease in discounting, or less impulsive, while smaller/negative numbers indicate an increase in discounting, or more impulsive.
Reinforcing Value of Food
Time frame: Session 2
Reinforcing value of food was measured using the relative reinforcing efficacy questionnaire in which participants are asked how many portions of food they would purchase at various prices. Intensity is the number of portions they would purchase and consume when the price is $0.
1 secondary outcome
Change in Working Memory Span
Time frame: Working Memory will be measured at baseline (session 1) and after receiving EFT/ERT Scarcity/Neutral intervention (up to 2 weeks post-baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32989616Stein JS, Craft WH, Paluch RA, Gatchalian KM, Greenawald MH, Quattrin T, Mastrandrea LD, Epstein LH, Bickel WK. Bleak present, bright future: II. Combined effects of episodic future thinking and scarcity on delay discounting in adults at risk for type 2 diabetes. J Behav Med. 2021 Apr;44(2):222-230. doi: 10.1007/s10865-020-00178-7. Epub 2020 Sep 28.
- Derived from this study: PubMed 32868537Bickel WK, Stein JS, Paluch RA, Mellis AM, Athamneh LN, Quattrin T, Greenawald MH, Bree KA, Gatchalian KM, Mastrandrea LD, Epstein LH. Does Episodic Future Thinking Repair Immediacy Bias at Home and in the Laboratory in Patients With Prediabetes? Psychosom Med. 2020 Sep;82(7):699-707. doi: 10.1097/PSY.0000000000000841.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available
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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.
Leonard H Epstein principal investigator
SUNY University at Buffalo
Warren K Bickel principal investigator
Virginia Polytechnic Institute and State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Episodic Future Thinking, Episodic Recent Thinking and Scarcity Narrative in people with PreDiabetes, run by Leonard Epstein at 2 sites 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 7 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: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 4 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Delay Discounting (time frame: Delay Discounting will be measured at baseline (session 1) and after receiving EFT/ERT and Scarcity/Narrative (within about 2 weeks)). The study lists 2 primary outcomes in all. 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 NCT03664726, which also lists 2 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 21 Feb 2023.