NCT05195138Completed
Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 23 Dec 2021
- Start date
- 31 May 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Type 2 diabetes
- NCT number
- NCT05195138
What you commit to
- Study type: Interventional
- Participants enrolled: 36
- From 31 May 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis (based on participant self-report)
Other
- Non-English speaking
- Currently pregnant
Who the study is looking for
- Age 19-70 years
- 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
- 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
- Presence of moderate-severe diabetes distress (score ≥2 on Diabetes Distress Scale
- Suboptimal glycemic control (elevated hemoglobin A1c (A1C) ≥7.5%)
Age in the registry: 19 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cooper Green Mercy Health Systems Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.