Mindfulness-Based Education for Type 2 Diabetes

Overseen By Caroline A Presley, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Non-English, Pregnant, Bipolar, others

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

Compensation: Varies

Number of Visits: 12

Duration: 6 months

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Diabetes distress is common affecting over one-third of people with type 2 diabetes, negatively impacting self-management and outcomes, and disproportionately affecting low-income individuals. The proposed project will conduct a pilot randomized controlled trial comparing Mindfulness-Based Diabetes Education to standard Diabetes Self-Management Education in adults with type 2 diabetes and elevated diabetes distress who receive care within safety-net healthcare systems in order to assess feasibility and acceptability.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current diabetes treatment, but you should confirm with the trial organizers.

Is mindfulness-based education safe for people with type 2 diabetes?

Mindfulness-based education, such as Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), has been studied in people with diabetes and is generally considered safe. Participants in these studies reported high satisfaction and no significant safety concerns were noted. ^{1 2 3 4 5}

How does the treatment Mindfulness-Based Diabetes Education differ from other treatments for type 2 diabetes?

Mindfulness-Based Diabetes Education is unique because it focuses on reducing stress and improving mental health through mindfulness practices, which can enhance diabetes self-management and reduce diabetes-related distress. Unlike traditional treatments that primarily target blood sugar levels, this approach emphasizes mental well-being and self-awareness to support overall diabetes care. ^{1 5 6 7 8}

What data supports the effectiveness of the treatment Mindfulness-Based Diabetes Education for Type 2 Diabetes?

Research shows that mindfulness-based interventions, like Mindfulness-Based Stress Reduction (MBSR), can significantly reduce diabetes-related stress and improve self-management behaviors. Studies also found improvements in diabetes distress, self-efficacy, and A1C levels, indicating better blood sugar control. ^{1 2 3 5 9}

Who Is on the Research Team?

Caroline A Presley, MD, MPH

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 19 years old or older.

I have been diagnosed with type 2 diabetes.

You are feeling very stressed about having diabetes.

Exclusion Criteria

Currently pregnant

I have been diagnosed with a severe psychiatric condition like bipolar disorder, schizophrenia, or have had psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Mindfulness-Based Diabetes Education or standard Diabetes Self-Management Education in 8 weekly group sessions followed by 2 bimonthly individual sessions

6 months

8 weekly group sessions, 2 bimonthly individual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at baseline, 2 months, and 6 months

6 months

3 visits (in-person) at baseline, 2 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness-Based Diabetes Education
• Standard Diabetes Self-Management Education (DSME)

Trial Overview 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.

How Is the Trial Designed?

Group I: Mindfulness-Based Diabetes Education Experimental Treatment 1 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 Education Active Control 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

The Mindful Stress Reduction in Diabetes Education (Mind-STRIDE) program, a mindfulness-based intervention for veterans, showed high satisfaction rates among participants and educators, with 71% of veterans completing the study.

Participants experienced significant improvements in diabetes-related outcomes, including reduced diabetes distress and better self-management behaviors, suggesting that mindfulness practices can positively impact diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mindful Approach to Diabetes Self-Management Education and Support for Veterans. DiNardo, M., Saba, S., Greco, CM., et al.[2022]

In a study with 38 participants, mindfulness-based stress reduction (MBSR) significantly decreased diabetes-related distress and improved glucose control, indicating its potential as an effective intervention for diabetes management.

Participants also experienced notable improvements in mental health factors such as depression, anxiety, and self-efficacy, suggesting that MBSR can enhance both diabetes management and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing diabetes distress and improving self-management with mindfulness. Whitebird, RR., Kreitzer, MJ., Vazquez-Benitez, G., et al.[2022]

Mindfulness-based interventions (MBIs) significantly reduce diabetes distress in adults, especially for those with high baseline distress, showing a moderate effect size of 0.48 based on a review of 10 studies with 649 participants.

The most effective MBIs were those based on mindfulness-based stress reduction therapy, delivered in group formats, and including home practice assignments, with long-term effects showing a large effect size of 0.56.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing the effect of mindfulness-based interventions on diabetes distress: a meta-analysis. Guo, J., Wang, H., Luo, J., et al.[2023]

In a study of 56 adults with diabetes, no significant differences were found in stress response, glycemic control, or vascular inflammation among those participating in Korean mindfulness-based stress reduction (K-MBSR), walking, or patient education.

However, both the K-MBSR and walking groups showed significant reductions in serum cortisol and PAI-1 levels, indicating potential benefits in stress hormone regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of Korean mindfulness-based stress reduction, walking, and patient education in diabetes mellitus. Jung, HY., Lee, H., Park, J.[2015]

Mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) significantly reduce depression and improve mental health quality of life in people with diabetes, based on a meta-analysis of nine studies involving randomized controlled trials.

These interventions also lead to a notable decrease in glycosylated hemoglobin (HbA1c), indicating better blood sugar control, although no significant effects were found on physical health quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy in People With Diabetes: A Systematic Review and Meta-Analysis. Ni, Y., Ma, L., Li, J.[2021]

A pilot study involving 100 participants showed that nurse-led mindfulness-based stress reduction (MBSR) therapy significantly reduced diabetes distress and improved diabetes self-efficacy and self-management over 12 weeks compared to standard diabetes education.

The nurse-led MBSR therapy also led to a notable reduction in HbA1c levels, indicating potential improvements in blood sugar control, making it a feasible and effective intervention for people with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a nurse-led mindfulness stress-reduction intervention on diabetes distress, diabetes self-management, and HbA1c levels among people with type 2 diabetes: A pilot randomized controlled trial. Guo, J., Wang, H., Ge, L., et al.[2022]

Mindfulness-based cognitive therapy (MBCT) significantly reduces diabetes-related distress (DD) and enhances self-care capabilities in patients with type 2 diabetes compared to routine diabetes health education alone, based on a study of 68 patients.

While both MBCT and routine diabetes health education improved aspects of self-care like diet and exercise, MBCT showed more sustained benefits in these areas, highlighting its potential as a low-cost psychological intervention to improve diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention Effect of Mindfulness-Based Cognitive Therapy on Diabetes-Related Distress and Self-Care. Bao, H.[2022]

Mindfulness-based stress reduction (MBSR) significantly improves mental health outcomes, such as reducing anxiety and depressive symptoms, and enhances mindfulness in diabetes patients, based on a systematic review of 10 studies with 718 participants.

While MBSR showed positive effects on mental health, it did not have a significant impact on lowering HbA1C levels, indicating that while it benefits psychological well-being, it may not directly influence blood sugar control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness-based stress reduction (MBSR) on the mental health, HbA1C, and mindfulness of diabetes patients: A systematic review and meta-analysis of randomised controlled trials. Fisher, V., Li, WW., Malabu, U.[2023]

A study involving 108 patients with type 2 diabetes showed that a 12-week mindfulness-based stress reduction (MBSR) program significantly improved mental health outcomes, including reductions in depression, anxiety, and stress levels.

The MBSR program also led to significant improvements in glycemic control, as indicated by reductions in hemoglobin A1C (HbA1C) levels, suggesting that mindfulness meditation can be an effective complementary approach for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Effects of 12 Weeks Mindfulness-Based Stress Reduction on Glycemic Control and Mental Health Indices in Women with Diabetes Mellitus Type 2. Nikkhah Ravari, O., Mousavi, SZ., Babak, A.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

A Mindful Approach to Diabetes Self-Management Education and Support for Veterans. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Reducing diabetes distress and improving self-management with mindfulness. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Factors influencing the effect of mindfulness-based interventions on diabetes distress: a meta-analysis. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Comparison of the effects of Korean mindfulness-based stress reduction, walking, and patient education in diabetes mellitus. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy in People With Diabetes: A Systematic Review and Meta-Analysis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a nurse-led mindfulness stress-reduction intervention on diabetes distress, diabetes self-management, and HbA1c levels among people with type 2 diabetes: A pilot randomized controlled trial. [2022]

7. Iran pubmed.ncbi.nlm.nih.gov

Intervention Effect of Mindfulness-Based Cognitive Therapy on Diabetes-Related Distress and Self-Care. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness-based stress reduction (MBSR) on the mental health, HbA1C, and mindfulness of diabetes patients: A systematic review and meta-analysis of randomised controlled trials. [2023]

9. India pubmed.ncbi.nlm.nih.gov

Evaluation of the Effects of 12 Weeks Mindfulness-Based Stress Reduction on Glycemic Control and Mental Health Indices in Women with Diabetes Mellitus Type 2. [2022]