Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: Standard Diabetes Self-Management Education (DSME); Behavioral: Mindfulness-Based Diabetes Education

Study type: Interventional

Funder types: Other

Identifiers

NCT05195138

IRB-300008617

Details and patient eligibility

About

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.

Full 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 diabetes and moderate-severe diabetes distress who receive their care from safety-net healthcare systems. The goal of this pilot RCT will be to assess the acceptability and feasibility of MBDE; acceptability will be assessed through qualitative follow-up interviews with participants and feasibility will be assessed through process measures. The investigators will recruit up to approximately 96 participants, 48 from each site to account for potential loss to follow up of up to 20%, for the study with total study duration of 6 months. Participants will be randomized 1:1 to each study arm. This study will also serve as a pilot test for the procedures of the RCT and of measures to be used in participant assessments.

The study will be conducted at two safety-net clinics that provide care for residents of Jefferson County using a sliding scale program based on income level - Cooper Green Mercy Health Services Authority (CGMHSA) and Alabama Regional Medicine Services (ARMS). CGMHSA, an affiliate of University of Alabama at Birmingham (UAB) Health System, is Jefferson County's public safety-net health care facility. CGMHSA provides care primarily to the indigent county residents, geographically spanning most of the Birmingham metropolitan area. Ambulatory care services are provided to patients who have type 2 diabetes through Cooper Green's Primary Care Clinic and multi-disciplinary Diabetes Clinic. ARMS is a Community Health Center serving the greater Birmingham area since 1983. ARMS provides ambulatory care for adults, including primary care, diabetes self-management education classes, and behavioral health services. ARMS offers services to patients, with or without insurance, on a sliding scale fee program based on income.

Trained study staff overseen by the study PI will recruit participants from CGMHSA and ARMS through three methods. Opt-out letters will be mailed to patients seen at CGMHSA or ARMS in the preceding three years with a diagnosis of type 2 diabetes; study staff will then call potential participants to provide more information about the study and to gauge their interest in participating. The investigators will obtain a HIPAA waiver to access potential participant information from the medical record in order to generate a recruitment list. The investigators will also conduct in-person recruitment of participants at CGMHSA and ARMS, as well as direct referral of potential participants by providers or patients. Trained study personnel will obtain screening consent from potential participants prior to screening for eligibility based on inclusion and exclusion criteria, which will include assessment of diabetes distress and hemoglobin A1c (A1C) through point-of-care (POC) finger-stick sample. Study staff will then obtain informed consent from eligible participants at the time of enrollment.

Both MDBE and standard DSME study arms will be delivered in-person, in a group setting with 10-14 participants per group. MBDE will be delivered in 8 weekly group sessions followed by 2 bimonthly individual, booster sessions conducted by phone for a total duration of 6 months. MBDE will be delivered by an interventionist with a background in nursing and training as an MBSR instructor, who will receive additional training in MBDE with an emphasis on content drawn from DSME. Standard DSME will be delivered by a certified diabetes educator in eight weekly sessions of 2 hours duration. Sessions will cover seven core content areas - healthy eating, physical activity, medication usage, self-monitoring, preventing and treating acute and chronic complications, healthy coping, and problem solving.

Total study duration will be six months; a trained study staff will complete assessments of participants in both study arms at baseline, 2 months, and 6 months. Participants in both study arms will complete assessments that will be conducted by trained study personnel, including interviewer-administered questionnaire, biometric assessment (height, weight, blood pressure), and POC A1C testing from a finger-stick sample at 3 time points - baseline, 2 months, and 6 months. Participants in the MBDE arm will be asked to participate in a focus group (estimated length 1 hour) at the 2 month time point. Participants will receive an incentive for their participation for each study assessment and for participation in a focus group.

Enrollment: 96 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups

Mindfulness-Based Diabetes Education

Experimental group

Description:

Mindfulness-Based Diabetes Education (MBDE) will be delivered in-person in a group of 10-14 participants during 8 weekly sessions followed by 2 bimonthly individual sessions. Sessions integrate Mindfulness-Based Stress Reduction and Diabetes Self-Management Education. MBDE will introduce breath awareness meditation, body scan, walking meditation, mindful yoga, and applying mindfulness to daily activities, as well as core areas from DSME. MBDE will include incremental goal setting to build participants' self-efficacy for diabetes self-management behaviors, mindful attention to diabetes self-management, and on development of social support in the group. Participants will complete daily home mindfulness exercises and self-monitoring of diabetes self-management behaviors.

Treatment:

Behavioral: Mindfulness-Based Diabetes Education

Standard Diabetes Self-Management Education

Active Comparator group

Description:

Standard DSME will be delivered in-person, in a group setting with 10-14 participants per group. Standard DSME will be delivered by a certified diabetes educator in eight weekly sessions of 2 hours duration. Sessions will cover seven core content areas - healthy eating, physical activity, medication usage, self-monitoring, preventing and treating acute and chronic complications, healthy coping, and problem solving.

Treatment:

Behavioral: Standard Diabetes Self-Management Education (DSME)