Mindfulness education for adults with diabetes distress
Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress
NA · University of Alabama at Birmingham · NCT05195138
This study is testing a new mindfulness program for adults with type 2 diabetes who are feeling stressed about their condition to see if it helps them manage their diabetes better than standard education.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05195138 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial compares Mindfulness-Based Diabetes Education (MBDE) to standard Diabetes Self-Management Education (DSME) for adults with type 2 diabetes experiencing elevated diabetes distress. The study aims to assess the feasibility and acceptability of MBDE among participants receiving care from safety-net healthcare systems. Approximately 96 participants will be recruited and randomized to either intervention group, with qualitative interviews and process measures used to evaluate outcomes over a 6-month period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19-70 with type 2 diabetes and moderate-severe diabetes distress receiving care at specific safety-net clinics.
Not a fit: Patients who are non-English speaking, currently pregnant, or have severe psychiatric comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve diabetes management and reduce distress for patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promise in using mindfulness-based interventions for chronic conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 19-70 years 2. 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 3. Receipt of care at Cooper Green Mercy Health Systems Authority or Alabama Regional Medical Services (one or more visits to primary care or diabetes clinic within the prior year 4. Presence of moderate-severe diabetes distress (score ≥2 on Diabetes Distress Scale 5. Suboptimal glycemic control (elevated hemoglobin A1c (A1C) ≥7.5%) Exclusion Criteria: 1. Non-English speaking 2. Currently pregnant 3. Diagnosis of severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis (based on participant self-report)
Where this trial is running
Birmingham, Alabama
- Cooper Green Mercy Health Systems — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Principal investigator: Caroline A Presley, MD, MPH — University of Alabama at Birmingham
- Study coordinator: Caroline A Presley, MD, MPH
- Email: capresley@uabmc.edu
- Phone: 205-934-7609
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, Diabetes distress, Mindfulness-based diabetes education