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Mindfulness-Based Education for Type 2 Diabetes
N/A
Recruiting
Led By Caroline A Presley, MD, MPH
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 19 years or older
Diagnosis of type 2 diabetes (based on the presence of two or more outpatient International Classification of Diseases (ICD-10) codes for type 2 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will assess if mindfulness-based diabetes education is feasible & acceptable for people with type 2 diabetes and elevated distress, especially those from lower income backgrounds.
Who is the study for?
This trial is for adults with type 2 diabetes who are experiencing high levels of stress related to their condition. Participants must be 19 or older, have a hemoglobin A1c level of at least 7.5%, and show moderate to severe distress on the Diabetes Distress Scale. They should also be receiving care from specific healthcare systems and not have severe psychiatric conditions like bipolar disorder or schizophrenia.Check my eligibility
What is being tested?
The study is testing Mindfulness-Based Diabetes Education against the standard Diabetes Self-Management Education in people with type 2 diabetes who are under a lot of stress because of their illness. It aims to see which method is more feasible and acceptable within low-income healthcare settings.See study design
What are the potential side effects?
Since this trial involves educational interventions rather than medications, side effects may include emotional discomfort or increased awareness of personal health issues due to mindfulness practices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 19 years old or older.
Select...
I have been diagnosed with type 2 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility: ability to randomize participants to study arms
Feasibility: barriers to participation in intervention sessions or completing study activities at home
Feasibility: distribution of participants by demographics
+13 moreSecondary outcome measures
Anxiety
Depressive symptoms
Diabetes distress
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Diabetes EducationExperimental Treatment1 Intervention
Mindfulness-Based Diabetes Education (MBDE) will be delivered in-person in a group of 10-14 participants during 8 weekly sessions followed by 2 bimonthly individual sessions. Sessions integrate Mindfulness-Based Stress Reduction and Diabetes Self-Management Education. MBDE will introduce breath awareness meditation, body scan, walking meditation, mindful yoga, and applying mindfulness to daily activities, as well as core areas from DSME. MBDE will include incremental goal setting to build participants' self-efficacy for diabetes self-management behaviors, mindful attention to diabetes self-management, and on development of social support in the group. Participants will complete daily home mindfulness exercises and self-monitoring of diabetes self-management behaviors.
Group II: Standard Diabetes Self-Management EducationActive Control1 Intervention
Standard DSME will be delivered in-person, in a group setting with 10-14 participants per group. Standard DSME will be delivered by a certified diabetes educator in eight weekly sessions of 2 hours duration. Sessions will cover seven core content areas - healthy eating, physical activity, medication usage, self-monitoring, preventing and treating acute and chronic complications, healthy coping, and problem solving.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,566 Total Patients Enrolled
Caroline A Presley, MD, MPHPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
85 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 19 years old or older.I have been diagnosed with a severe psychiatric condition like bipolar disorder, schizophrenia, or have had psychosis.I have been diagnosed with type 2 diabetes.You are feeling very stressed about having diabetes.I do not speak English.You have been to Cooper Green Mercy Health Systems Authority or Alabama Regional Medical Services for primary care or diabetes treatment in the past year.Your long-term blood sugar levels are not well controlled (HbA1c is 7.5% or higher).
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness-Based Diabetes Education
- Group 2: Standard Diabetes Self-Management Education
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research investigating participants of at least 25 years in age?
"This clinical trial mandates that participants are aged between 19 and 64. Additionally, there are 187 studies for those younger than 18 and 984 trials available to individuals above 65 years old."
Answered by AI
Would I qualify to partake in this scientific exploration?
"Eligibility for this trial is contingent on the patient having type 2 diabetes and falling within the age range of 19 to 64 years old. A total of 96 subjects are being enrolled in this experiment."
Answered by AI
Are people still welcome to apply for this clinical trial?
"Affirmative. According to the clinicaltrials.gov website, this research study is actively recruiting participants since May 31st of 2023 with a recent update on May 26th 2023. The trial needs 96 volunteers from 1 location."
Answered by AI
How many people is the trial recruiting to participate?
"Indeed, clinicaltrials.gov reveals that this medical study is still in the process of recruiting patients. The trial was first listed on May 31st, 2023 and last updated on May 26th, 2023 with 96 applicants required at 1 location."
Answered by AI
What are the major goals of this experiment?
"The primary measure of success for this trial, assessed over a two month period is the patient's satisfaction with the intervention. Secondary outcomes include Diabetes Distress (evaluated using the 17-item DDS questionnaire), Hemoglobin A1c (measured via finger-stick testing) and diabetes self-management behaviors (assessed through a 16 point Likert scale)."
Answered by AI
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