Episodic Future Thinking for Type 2 Diabetes

Overseen By Megan Stuart

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Disqualifiers: Gestational diabetes, Pregnancy, Intellectual impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with type 2 diabetes manage their condition by focusing on future benefits rather than immediate ones. It tests a method called Episodic Future Thinking (EFT), where participants imagine vivid future events and use a guided smartphone app to make healthier lifestyle choices. Another group will use the app to focus on health information instead. Individuals with type 2 diabetes who have a high blood sugar level (HbA1c of 7.7% or more), live in urban or rural areas, and have a body mass index (BMI) of 30 or higher might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative ways to manage diabetes and improve long-term health.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, as the trial focuses on lifestyle changes and not medication changes.

What prior data suggests that Episodic Future Thinking is safe for managing type 2 diabetes?

Research has shown that Episodic Future Thinking (EFT) is generally well-tolerated by people with type 2 diabetes and obesity. One study found that EFT helped individuals focus more on long-term health benefits rather than short-term comforts, with no reports of serious side effects. Another study examined EFT's use for people with prediabetes during a weight loss program and also found no major safety concerns, suggesting that EFT can be safely added to lifestyle changes like diet and exercise. Overall, evidence suggests that EFT is a safe way to help manage type 2 diabetes by promoting healthier lifestyle choices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Episodic Future Thinking (EFT) for Type 2 Diabetes because it offers a novel, psychological approach that complements traditional treatments like medication and lifestyle changes. Unlike standard methods that focus primarily on physical health, EFT engages the mind by encouraging participants to vividly imagine future events, which can help motivate better dietary and physical activity habits. This mental technique, supported by a smartphone app, aims to create a stronger connection between present actions and future health outcomes, potentially leading to more sustainable behavior changes. Additionally, pairing EFT with diet and exercise support enhances its effectiveness, making it a promising tool in managing Type 2 Diabetes.

What evidence suggests that Episodic Future Thinking could be an effective treatment for type 2 diabetes?

Research has shown that Episodic Future Thinking (EFT), which participants in this trial may engage in, can assist people with type 2 diabetes (T2D) by making future health benefits feel more immediate and real. Studies have found that EFT reduces the tendency to undervalue future rewards, known as delay discounting, in people with T2D. Specifically, one study discovered that those who practiced EFT managed their weight and blood sugar levels better. Another study demonstrated that EFT helped people eat less and improve their overall health habits. These findings suggest that EFT could be a promising way to encourage lifestyle changes in people with T2D. ^{1 2 3 6 7}

Who Is on the Research Team?

Jeffrey Stein, PhD

Principal Investigator

Fralin Biomedical Research Institute at Virginia Tech Carilion

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who live in urban or rural areas, have an HbA1c level of at least 7.7%, and a body mass index (BMI) of 30 or higher. It's not suitable for those with intellectual impairments, gestational diabetes, pregnant or lactating women, non-ambulatory individuals, or unmanaged psychiatric conditions.

Inclusion Criteria

You are very overweight.

You live in a city or countryside.

Your HbA1c level is 7.7% or higher.

Exclusion Criteria

I cannot walk on my own.

I have an intellectual disability.

Pregnancy or lactating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Remote assessments

Baseline Assessment

Participants complete remote assessments of dietary intake, physical activity, and sociodemographic information

1 week

Remote assessments

Treatment

Participants engage in episodic future thinking or control thinking, with diet and physical activity support, self-monitoring, and case management

24 weeks

Thrice-daily smartphone app prompts

Follow-up

Participants are monitored for changes in glycemic control, BMI, dietary intake, physical activity, and medication adherence

4 weeks

Remote assessments at Weeks 8 and 24

What Are the Treatments Tested in This Trial?

Interventions

• Episodic Future Thinking

Trial Overview The study tests if 'Episodic Future Thinking'—imagining future events to influence present decisions—can help manage type 2 diabetes better than 'Healthy Information Thinking'. Participants are randomly assigned to one of these two groups and followed over a period of 24 weeks.

How Is the Trial Designed?

Group I: Episodic Future Thinking Experimental Treatment 1 Intervention

Participants will generate vivid, episodic events and be prompted via a guided smartphone app to engage in EFT in their daily lives. EFT will be paired with diet and physical activity support.

Group II: Healthy Information Thinking Active Control 1 Intervention

Participants will be prompted via a guided smartphone app to thinking about their written responses to informational health vignettes during their daily lives. The HIT condition will be paired with diet and physical activity support.

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Carilion Clinic

Collaborator

Trials

85

Recruited

15,400+

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

Published Research Related to This Trial

The pilot goal-oriented episodic future thinking (GoEFT) intervention was well-accepted by low-income overweight or obese mothers, with participants appreciating the structured approach to setting and evaluating goals.

The intervention demonstrated significant efficacy in promoting weight loss, increasing fruit and vegetable intake, and improving emotional control, along with reducing fat and sugar intake and alleviating stress, indicating its potential as an effective weight management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Goal-Oriented Episodic Future Thinking Weight Loss Intervention for Low-Income Overweight or Obese Young Mothers. Chang, MW., Tan, A., Wegener, DT., et al.[2023]

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but it carries risks of serious complications like hyperglycemia and hypoglycemia due to various factors including pump failures and user errors.

There is a lack of transparency and sufficient data on the safety and long-term efficacy of insulin pumps, highlighting the need for better regulatory practices and more public funding for research to improve user education and prevent adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2022]

Episodic Future Thinking (EFT) significantly reduces delay discounting in adults with type 2 diabetes and obesity, indicating its potential as a clinical tool to promote healthier behaviors.

In a study of 434 participants, those engaging in EFT showed lower levels of delay discounting compared to those in the Health Information Thinking (HIT) and no-cue control conditions, suggesting that EFT is more effective than diabetes-specific health information in influencing decision-making related to health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Episodic future thinking in type 2 diabetes: Further development and validation of the Health Information Thinking control for clinical trials. Brown, JM., Bickel, WK., Epstein, LH., et al.[2023]

Episodic Future Thinking (EFT) was found to significantly reduce delay discounting, which is the tendency to devalue future rewards, compared to a novel control group using health information thinking (HIT) in a study of 254 participants.

The study suggests that while EFT is effective in reducing maladaptive health behaviors, further research is needed to establish the HIT procedure as a reliable control for other outcomes in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating episodic future thinking manipulations for clinical use: Development of a clinical control. Rung, JM., Epstein, LH.[2023]

Mild cognitive dysfunction is a common complication of both Type 1 and Type 2 diabetes, with children diagnosed early (before age 6 or 7) showing particularly pronounced cognitive deficits in areas like attention and executive functions.

Improving metabolic control in diabetes patients can potentially slow cognitive decline, highlighting the importance of behavioral strategies to enhance adherence to treatment and manage blood glucose levels effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocognitive consequences of diabetes. Ryan, CM., van Duinkerken, E., Rosano, C.[2022]

Older adults with type 2 diabetes are at a higher risk for cognitive impairment, which can negatively impact their ability to manage their diabetes effectively, including skills like insulin adjustment and medication adherence.

The review highlights significant correlations between cognitive measures (like memory and executive function) and various aspects of diabetes self-management, suggesting that cognitive health is crucial for maintaining good glycemic control in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of cognition on self-management of type 2 diabetes in older people. Tomlin, A., Sinclair, A.[2022]

In a study of 236 late adolescents with Type 1 diabetes, better diabetes goal planning was linked to improved adherence to treatment and better glycemic control, as measured by HbA1c levels.

Daily fluctuations in goal planning significantly impacted diabetes management, with adolescents showing better adherence and lower blood glucose levels on days with higher goal planning; those with poorer executive functioning were particularly affected by lapses in planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual differences and day-to-day fluctuations in goal planning and type 1 diabetes management. Wiebe, DJ., Baker, AC., Suchy, Y., et al.[2023]

In a study of 98 individuals with type 2 diabetes, 52% showed signs of executive function impairment, which was linked to inadequate glycaemic control (HBA(1c) > or =7%).

The research found that those with executive function impairment were nearly five times more likely to have poor glycaemic control, highlighting the importance of cognitive health in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Executive cognitive impairment detected by simple bedside testing is associated with poor glycaemic control in type 2 diabetes. de Wet, H., Levitt, N., Tipping, B.[2022]

In a study involving 232 adults with type 2 diabetes, those who underwent an intensive lifestyle intervention (ILI) showed reduced brain activity related to food rewards compared to those in a diabetes support and education (DSE) group, suggesting better control over food-related cravings.

Participants in the ILI who lost more weight demonstrated increased brain activation associated with cognitive control and attention when exposed to high-calorie food cues, indicating that long-term participation in weight loss programs can lead to lasting changes in how the brain responds to food.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Intensive Lifestyle Intervention on Neural Food Cue Reactivity: Action for Health in Diabetes Brain Ancillary Study. McDermott, KD., Williams, SE., Espeland, MA., et al.[2020]

A study involving 204 adults newly diagnosed with Type 2 diabetes found that having a future-oriented time perspective is linked to better weight management behaviors, such as healthier dietary choices and increased physical activity over a 6-month period.

The positive impact of a future-oriented mindset on these behaviors is primarily mediated by stronger intentions to engage in weight management, suggesting that encouraging future thinking could enhance treatment outcomes for individuals with Type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time perspective and weight management behaviors in newly diagnosed Type 2 diabetes: a mediational analysis. Hall, PA., Fong, GT., Cheng, AY.[2022]

A novel text messaging intervention based on the theory of planned behaviour showed a marginally significant improvement in evening insulin administration among young adults with type 1 diabetes, particularly in those with low conscientiousness and consideration of future consequences.

The study suggests that individual personality traits can influence the effectiveness of behavioral interventions, highlighting the need for further research with larger samples and more objective measures of insulin adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploratory randomised controlled trial using short messaging service to facilitate insulin administration in young adults with type 1 diabetes. Louch, G., Dalkin, S., Bodansky, J., et al.[2021]

A total of 684 adverse drug event reports related to insulin therapy and 84 reports for oral glucose-lowering agents were analyzed from care homes, highlighting a significant risk of harm for older residents with diabetes.

The most frequent errors involved incorrect or unclear dosing, with insulin errors leading to one reported death, indicating a critical need for improved medication management in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes medication patient safety incident reports to the National Reporting and Learning Service: the care home setting. Milligan, FJ., Krentz, AJ., Sinclair, AJ.[2016]

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but users face significant risks from potential errors in insulin delivery, which can lead to serious health issues like hyperglycemia or hypoglycemia.

Current safety evaluations of insulin pumps are inadequate, with limited transparency in reporting adverse events and insufficient long-term data on real-world usage, highlighting the need for improved regulatory practices and more comprehensive research on pump therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2018]

A study analyzing 2429 adverse events (AEs) related to insulin pumps revealed that 92% of these events had clinical consequences, with critical hyperglycemia (47%) and critical hypoglycemia (24%) being the most common issues reported.

The analysis identified that only 50% of the AEs provided enough information to determine root causes, with common issues linked to pump or pod malfunctions, flow obstructions, and infusion set problems, highlighting the need for better reporting and investigation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes. Estock, JL., Codario, RA., Keddem, S., et al.[2023]

A systematic review of 68 observational studies on non-serious adverse drug events (ADEs) in type 2 diabetes revealed that many studies used inadequate methods for detecting ADEs, with only a third exceeding regulatory requirements for sample size and follow-up duration.

The most effective method for identifying a diverse range of ADEs was solicited surveillance by healthcare professionals, while patient surveys primarily focused on specific issues like hypoglycemia, indicating a need for better methodologies and a combination of approaches to fully capture ADEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of methods used in assessing non-serious adverse drug events in observational studies among type 2 diabetes mellitus patients. Hakobyan, L., Haaijer-Ruskamp, FM., de Zeeuw, D., et al.[2022]

Citations

1. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0289478

Episodic future thinking in type 2 diabetes - Research journals These results suggest that engaging in EFT, but not diabetes-specific HIT, results in lower delay discounting in adults with type 2 diabetes and obesity.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03732209

A Remotely Delivered Episodic Future Thinking ... The goals of this project are to assess the efficacy of remotely delivered episodic future thinking for reducing delay discounting and improving management ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8744570/

Effects of 6-month episodic future thinking training on delay ... This study tested EFT training compared to control for people with prediabetes enrolled in a 6-month weight loss program on DD, weight, HbA1c, and physical ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748923002328

Effects of episodic future thinking in health behaviors for ... This review demonstrated the positive effects of EFT on delay discounting, energy intake, grocery purchased, and BMI among individuals with health behaviors ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076241245583

Perceptions and effectiveness of episodic future thinking as ... Studies have further shown DD associated with the transition of prediabetes to diabetes, poorer outcomes in Type 2 Diabetes Mellitus (T2DM) and other conditions ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9669959/

Methodological considerations in the use of episodic future ... Likewise, periodic engagement in EFT may increase medication adherence in adults with type 2 diabetes or prediabetes (26). In studies examining the effects of ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05280925/episodic-future-thinking-to-improve-management-of-type-2-diabetes-remote-delivery-and-outcomes-assessment

Episodic Future Thinking to Improve Management of Type ... This study will conduct a randomized 24-week remote clinical trial comparing repeated measures ANOVA, with group (episodic future thinking [EFT]/ ...