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Mindfulness-Based Stress Reduction for Diabetes (De-Stress Trial)
N/A
Recruiting
Led By Nazia T Raja-Khan, M.D., M.S.
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Hemoglobin A1c ≥ 7.5% within 10 weeks and 2 days (72 days) before the start of the study intervention (Orientation session)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights
De-Stress Trial Summary
This trial will compare the effects of an online mindfulness-based stress reduction intervention to an active control stress management education on glucose control in adults with uncontrolled type 1 or type 2 diabetes.
Who is the study for?
Adults with uncontrolled type 1 or type 2 diabetes, high stress levels, and an HbA1c level of at least 7.5% can join this study. Participants need internet access for online sessions and must have been diagnosed with diabetes for over a year. Exclusions include certain psychiatric conditions, current pregnancy, enrollment in other studies or stress programs, and non-English speakers.Check my eligibility
What is being tested?
The trial is testing the effectiveness of an online Mindfulness-based Stress Reduction (MBSR) program against Stress Management Education (SME) to improve glucose control in diabetics. The study involves live virtual classes over six months with follow-ups to compare the two methods.See study design
What are the potential side effects?
Since this trial focuses on stress reduction techniques rather than medication, side effects are minimal but may include discomfort from discussing personal issues during sessions or potential frustration if no improvement in stress levels is perceived.
De-Stress Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My last Hemoglobin A1c level was 7.5% or higher.
Select...
I have been diagnosed with diabetes for over a year.
De-Stress Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Hemoglobin A1c from Baseline to 6 months
Secondary outcome measures
Change in Diabetes Distress Scale from Baseline to 2 months
Change in Diabetes Distress Scale from Baseline to 6 months
Change in Hemoglobin A1c from Baseline to 2 months
+2 moreSide effects data
From 2013 Phase 4 trial • 89 Patients • NCT010338512%
muscle soreness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mindfulness Based Stress Reduction
Stress Management Education
De-Stress Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness Based Stress ReductionExperimental Treatment1 Intervention
Group II: Stress Management EducationActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Based Stress Reduction
2016
Completed Phase 4
~3320
Find a Location
Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
494 Previous Clinical Trials
2,798,552 Total Patients Enrolled
Penn State UniversityOTHER
355 Previous Clinical Trials
125,467 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,301 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken a course in mindfulness-based stress reduction (MBSR) before.I am currently enrolled in a stress reduction program or another study.You have been diagnosed with a drinking or drug problem in the past year.I am 18 years old or older.You currently have thoughts of harming yourself.You have a high level of stress based on a specific score on a stress scale.You have a history of severe mental health conditions like bipolar disorder or psychosis, but mild depression or anxiety under the care of a primary care doctor is okay.My last Hemoglobin A1c level was 7.5% or higher.I haven't been admitted for psychiatric reasons in the last 2 years or visited the ER for one in the last 10 weeks.I am either a man or a woman.I have been diagnosed with diabetes for over a year.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness Based Stress Reduction
- Group 2: Stress 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.
Are participants being actively sought to participate in this experiment?
"Affirmative. Data on clinicaltrials.gov demonstrates that this medical study, which was initially posted in July of 2020 is still actively seeking enrollees. In total, 290 individuals are required at a single trial site."
Answered by AI
How many participants are accepted within the scope of this experiment?
"Affirmative. The clinicaltrials.gov listing shows that this trial is actively recruiting participants, with the first posting on July 28th 2020 and an update as recent as August 3rd 2022. This experiment requires 290 patients to be sourced from one medical centre."
Answered by AI
Who else is applying?
What state do they live in?
California
Alabama
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Penn State College of Medicine, Penn State Milton S Hershey Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How responsive is this trial?
Typically responds via
Phone Call
Email
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