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Episodic Future Thinking for Type 2 Diabetes
N/A
Recruiting
Led By Jeffrey Stein, PhD
Research Sponsored by Virginia Polytechnic Institute and State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
Study Summary
This trial will compare the effects of episodic future thinking (EFT) on delaying discounting in adults with type 2 diabetes.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the interventions involve psychological strategies rather than medications, traditional side effects like you'd see with drugs aren't expected. However, participants may experience emotional discomfort when engaging in these thinking exercises.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in body mass index from baseline (Week 0) to Week 24
Change in body mass index from baseline (Week 0) to Week 8
Change in glycemic control from baseline (Week 0) to Week 24
+1 moreSecondary outcome measures
Change in dietary intake from baseline (Week 0) to Week 24
Change in dietary intake from baseline (Week 0) to Week 8
Change in physical activity from baseline (Week 0) to Week 24
+4 moreOther outcome measures
Change in delay discounting from baseline (Week 0) to Week 24
Change in delay discounting from baseline (Week 0) to Week 8
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Episodic Future ThinkingExperimental Treatment1 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 ThinkingActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Episodic Future Thinking
2018
N/A
~460
Find a Location
Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
145 Previous Clinical Trials
27,877 Total Patients Enrolled
Carilion ClinicOTHER
73 Previous Clinical Trials
12,657 Total Patients Enrolled
University at BuffaloOTHER
132 Previous Clinical Trials
98,859 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot walk on my own.I have an intellectual disability.You are very overweight.You are currently diagnosed with gestational diabetes.You live in a city or countryside.Your HbA1c level is 7.7% or higher.I do not have any untreated mental health conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Episodic Future Thinking
- Group 2: Healthy Information Thinking
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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