Mindfulness Meditation for Type 2 Diabetes
(E-RCT Trial)
Recruiting in Palo Alto (17 mi)
Overseen byAlana Biggers
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Illinois at Chicago
Disqualifiers: Untreated sleep apnea, Severe insomnia, Cognitive impairments, Alcohol abuse, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The proposed research and training will allow Dr. Alana Biggers to obtain critical research skills and study a mindfulness meditation program designed to improve sleep and reduce stress in African-American adults with diabetes. If effective, this program may reduce the risk of cardiovascular disease among African-Americans with type 2 diabetes who are at high risk of cardiovascular disease.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Mindfulness Meditation for Type 2 Diabetes?
Is mindfulness meditation safe for people with diabetes?
How does mindfulness meditation differ from other treatments for type 2 diabetes?
Mindfulness meditation is unique because it focuses on reducing stress and improving mental health, which can help with diabetes management by enhancing relaxation, sleep, and coping skills. Unlike traditional treatments that primarily target blood sugar levels, this approach addresses the psychological and emotional aspects of living with diabetes.12378
Eligibility Criteria
This trial is for African-American adults aged 21-75 with type 2 diabetes living in the greater Chicagoland area. Participants must have a mobile device with internet and be able to text. They can't join if they already practice mindfulness, have severe sleep disorders, major cognitive or psychiatric issues, substance abuse problems, or untreated obstructive sleep apnea.Inclusion Criteria
I have been diagnosed with type 2 diabetes.
Mobile device (smartphone, tablet, or computer) with the ability to connect to the internet if remote online delivery
You have a mobile phone with unlimited text messaging.
See 4 more
Exclusion Criteria
I regularly practice mindfulness.
I have severe insomnia, narcolepsy, or a REM sleep disorder.
You have a history of alcohol or drug abuse.
See 4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants engage in 8 two-hour mindfulness meditation classes over 8 weeks, with text messaging support between classes
8 weeks
8 visits (in-person or online)
Follow-up
Participants are monitored for sleep quality, perceived stress, and cardiometabolic risk factors after treatment
8 weeks
2 visits (in-person or virtual)
Treatment Details
Interventions
- Mindfulness Meditation (Behavioral Intervention)
Trial OverviewThe study tests a mindfulness meditation program aimed at improving sleep and reducing stress in African-Americans with type 2 diabetes. The goal is to see if this program can lower their risk of cardiovascular disease.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness Meditation ClassesExperimental Treatment1 Intervention
8 mindfulness classes: Participants will engage in 8 two-hour mind and body practice classes over 8 weeks in-person or online (during the pandemic). You will receive compensation for your participation and a yoga mat. You will need to wear comfortable clothing. These sessions can be done sitting in chair, sitting on the floor, or standing.
Text messaging., in between classes you will receive text messages to encourage mind and body practices at home. Text messaging may appear as the following:
1.Do you have time to meditate right now? Yes or No. 2.Did you practice your mindfulness today? Yes or no. 3.Remember to wind down this evening and do not drink any caffeinated beverages 4 hours before bed.
Group II: Usual CareActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Illinois at ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Mind-Body Interactions and Mindfulness Meditation in Diabetes. [2022]Diabetes is associated with significant psychological distress. It is, therefore, important to ensure the physical and emotional as well as psychosocial wellbeing of individuals living with diabetes. Meditation-based strategies have been evaluated for their complementary role in several chronic disorders including depression, anxiety, obesity, hypertension, cardiovascular disease and diabetes. The practice of meditation is associated with reduction in stress and negative emotions and improvements in patient attitude, health-related behaviour and coping skills. There is increased parasympathetic activity with reduction in sympathetic vascular tone, stress hormones and inflammatory markers. Additionally, several studies evaluated the role of mindfulness-based stress reduction in diabetic individuals and demonstrated modest improvements in body weight, glycaemic control and blood pressure. Thus, mindfulness meditation-based intervention can lead to improvements across all domains of holistic care - biological, psychological and social. Though most of these studies have been of short duration and included small numbers of patients, meditation strategies can be useful adjunctive techniques to lifestyle modification and pharmacological management of diabetes and help improve patient wellbeing.
Reducing diabetes distress and improving self-management with mindfulness. [2022]Stress associated with diabetes makes managing diabetes harder. We investigated whether mindfulness-based stress reduction (MBSR) could reduce diabetes distress and improve management. We recruited 38 participants to complete an MBSR program. Surveys and lab values were completed at baseline and post-intervention. Participants showed significant improvement in diabetes-related distress (Cohen's d -.71, p
A mixed-methods pilot study of the acceptability and effectiveness of a brief meditation and mindfulness intervention for people with diabetes and coronary heart disease. [2022]Mindfulness-based interventions can successfully target negative perseverative cognitions such as worry and thought suppression, but their acceptability and effectiveness in people with long-term conditions is uncertain. We therefore pilot tested a six-week meditation and mindfulness intervention in people (n = 40) with diabetes mellitus and coronary heart disease. We used a sequential mixed-methods approach that measured change in worry and thought suppression and qualitatively explored acceptability, feasibility, and user experience with a focus group (n = 11) and in-depth interviews (n = 16). The intervention was highly acceptable, with 90% completing ≥5 sessions. Meditation and mindfulness skills led to improved sleep, greater relaxation, and more-accepting approaches to illness and illness experience. At the end of the six-week meditation course, worry, and thought suppression were significantly reduced. Positive impacts of mindfulness-based interventions on psychological health may relate to acquisition and development of meta-cognitive skills but this needs experimental confirmation.
The Impact of Mindfulness-Based Stress Reduction on Emotional Wellbeing and Glycemic Control of Patients with Type 2 Diabetes Mellitus. [2022]The aim of the study was to determine the effect of mindfulness-based stress reduction (MBSR) intervention on emotion regulation and glycemic control of patients with type 2 diabetes.
Comparison of the effects of Korean mindfulness-based stress reduction, walking, and patient education in diabetes mellitus. [2015]The purpose of this study was to compare the effects of Korean mindfulness-based stress reduction (K-MBSR), walking, and patient education regarding diabetes mellitus (DM) on stress response, glycemic control, and vascular inflammation in patients with diabetes mellitus. A cluster randomized trial including 56 adults with diabetes mellitus (K-MBSR group = 21, walking group = 18, patient education group = 17) was conducted between 13 July and 14 September 2012. The questionnaire included the Diabetes Distress Scale and Perceived Stress Response Inventory. Fasting blood samples were used to measure levels of cortisol, blood glucose, plasminogen activator inhibitor-1 (PAI-1), and tissue plasminogen activator (t-PA). There were no statistically significant differences between the effects of K-MBSR, walking, and patient education on stress, glycemic control, or vascular inflammation. However, in the K-MBSR and walking groups, significant reductions in the levels of serum cortisol and PAI-1 were observed. A significant reduction in psychological responses to stress was observed in the walking and patient education groups. Longitudinal studies could provide better insight into the impact of K-MBSR, walking, and patient education on health outcomes in adults with diabetes mellitus.
The association between mindfulness and emotional distress in adults with diabetes: could mindfulness serve as a buffer? Results from Diabetes MILES: The Netherlands. [2022]People with diabetes have a higher risk of emotional distress (anxiety, depression) than non-diabetic or healthy controls. Therefore, identification of factors that can decrease emotional distress is relevant. The aim of the present study was to examine (1) the association between facets of mindfulness and emotional distress; and (2) whether mindfulness might moderate the association between potential adverse conditions (stressful life events and comorbidity) and emotional distress. Analyses were conducted using cross-sectional data (Management and Impact for Long-term Empowerment and Success--Netherlands): 666 participants with diabetes (type 1 or type 2) completed measures of mindfulness (Five Facet Mindfulness Questionnaire-Short Form; FFMQ-SF), depressive symptoms (Patient Health Questionnaire; PHQ-9), and anxiety symptoms (General Anxiety Disorder assessment; GAD-7). Hierarchical multiple regression analyses showed significant associations between mindfulness facets (acting with awareness, non-judging, and non-reacting) and symptoms of anxiety and depression (β = -0.20 to -0.33, all p
Association between a guided meditation practice, sleep and psychological well-being in type 2 diabetes mellitus patients. [2021]Background Type 2 diabetes mellitus [T2DM] is one of the leading causes for mortality. This study examined the role of an self-awareness based guided meditation practice, Cyclic Meditation [CM] on perceived stress, anxiety, depression, sleep and quality of life in T2DM patients. Design A single arm pre-post design was used for the study. Setting The study was conducted in an auditorium for general public diagnosed with T2DM in Ernakulam, Kerala, India. Subjects Subjects were 30 T2DM patients, both male and female of age 50.12 ± 11.15 years and BMI 25.14 ± 4.37 Kg/m2 and not having a history of hospitalisation were randomly recruited for the study following advertisements in national dailies. Intervention Participants completed a supervised CM programs in the evenings, 5 days a week for 4 weeks, in addition to their regular medication. Measures Perceived stress, anxiety and depression were assessed with Perceived Stress Scale, State Anxiety Inventory and Beck's depression inventory, respectively. Sleep and quality of life were assessed with Pittsburgh Sleep Quality Index and WHO-Quality of Life - BREF respectively. Analysis Changes in the outcome measures from baseline to 4 weeks were compared using paired "t" test. Results After 4 weeks, the quality of life and sleep scores increased 7.1% [p = 0.001] and 32.7% [p = 0.001], respectively. The perceived stress, anxiety and depression reduced 26.1% [p = 0.001], 16.01% [p = 0.003] and 37.63% [p = 0.006] as compared to their baseline reports. The CM practice also reduced daytime dysfunction. Conclusions A guided self-awareness based meditation program was safe and effective in improving depression, anxiety, perceived stress and enhance sleep and quality of life in T2DM patients, which could be helpful in reducing the future complications of T2DM. Mind management is essential along with medical management to achieve better clinical results.
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]The clinically standardised mindfulness-based stress reduction (MBSR) has been utilised as an intervention for improving mental health among diabetes patients The present study aimed to assess the effectiveness of mindfulness-based stress reduction (MBSR) on the mental health, haemoglobin A1c (HbA1C), and mindfulness of diabetes patients. A systematic review and meta-analysis approach was employed to review randomised controlled trials published in the English language between the inception of eight databases to July 2022. Eleven articles from 10 studies, with a combined sample size of 718 participants, were included in the systematic review, and nine studies were included in the meta-analysis. In the meta-analysis, outcomes at post-intervention and follow-up were compared between the MBSR intervention and control groups with an adjustment of the baseline values. The results showed that MBSR demonstrated effects at post-intervention and follow-up (in a period between one to 12 months with a mean length of 4.3 months) in reducing anxiety and depressive symptoms, and enhancing mindfulness, with large effect sizes. However, the effect of MBSR on reducing stress was observed at follow-up, but not at post-intervention. Effects of MBSR on HbA1C were not detected at post-intervention and follow-up. The findings suggest that MBSR appears to be an effective treatment for improving mental health conditions and mindfulness in people with diabetes. The measurement of cortisol is recommended to be used as a biological measure to evaluate the effectiveness of MBSR in diabetes patients in future research.