Status:
RECRUITING
Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
19-70 years
Phase:
NA
Brief Summary
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 pro...
Detailed Description
The investigators will conduct a pilot randomized controlled trial (RCT) of Mindfulness-Based Diabetes Education (MBDE) versus standard Diabetes Self-Management Education (DSME) in adults with type 2 ...
Eligibility Criteria
Inclusion
- 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%)
Exclusion
- Non-English speaking
- Currently pregnant
- Diagnosis of severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis (based on participant self-report)
Key Trial Info
Start Date :
May 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05195138
Start Date
May 31 2023
End Date
December 31 2025
Last Update
December 16 2025
Active Locations (1)
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1
Cooper Green Mercy Health Systems
Birmingham, Alabama, United States, 35233