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Remotely Delivered Mindfulness-Based Diabetes Education

Remotely Delivered Mindfulness-Based Diabetes Education for Rural Adults With Uncontrolled Diabetes and Elevated Distress

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be recruited through opt-out letters and phone calls to adults with diabetes seen within the preceding two years at study sites, as well as through in-person recruitment during clinic or through direct referral by provider or patient."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares diabetes education with mindfulness (paying attention to the present) and remote blood sugar tracking to standard diabetes education. Both programs help people learn to manage diabetes. The study is for rural Black adults with type 2 diabetes and high diabetes-related stress who get care at participating health centers, and will check how well the program works in practice and how people feel about it.

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 remotely delivered Mindfulness-Based Diabetes Education plus remote patient monitoring of blood glucose to standard Diabetes Self-Management Education in rural Black adults with type 2 diabetes and elevated diabetes distress who receive care within federally qualified health centers to assess feasibility and acceptability.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 19 or older.
  • Have type 2 diabetes.
  • Identify as Black.
  • Get care at a study site and had at least one visit there in the past year.
  • Have moderate to severe diabetes-related stress, with a score of 2 or higher on the Diabetes Distress Scale.
  • Have an A1C of 8% or higher. A1C is a blood test that shows average blood sugar levels.

Who can't join

  • Do not speak English.
  • Are currently pregnant.
  • Have a severe mental health condition, including bipolar disorder or schizophrenia, or a history of psychosis (trouble knowing what is real).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * age 19 years or older * diagnosis of type 2 diabetes * Black race (self-report) * receipt of care at one of the study sites with one or more visits to within the prior year * presence of elevated diabetes distress (score ≥2 on Diabetes Distress Scale indicating moderate-severe distress) * uncontrolled diabetes indicated by an elevated hemoglobin A1c (A1C) ≥8% Exclusion Criteria (Presence of any of the following criteria): * non-English speaker * current pregnancy * diagnosis of a severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis

Study sites (1)

AL