RECRUITING

Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress

Quick Facts

Study Start:2023-05-31
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05195138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 19-70 years
  2. 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. 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. 4. Presence of moderate-severe diabetes distress (score ≥2 on Diabetes Distress Scale
  5. 5. Suboptimal glycemic control (elevated hemoglobin A1c (A1C) ≥7.5%)
  1. 1. Non-English speaking
  2. 2. Currently pregnant
  3. 3. Diagnosis of severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis (based on participant self-report)

Contacts and Locations

Study Contact

Caroline A Presley, MD, MPH
CONTACT
205-934-7609
capresley@uabmc.edu

Principal Investigator

Caroline A Presley, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

Cooper Green Mercy Health Systems
Birmingham, Alabama, 35233
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Caroline A Presley, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-31
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-05-31
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Diabetes distress
  • Mindfulness-based diabetes education

Additional Relevant MeSH Terms

  • Type 2 Diabetes