Intervention Mapping to Adapt a Mindfulness-based Intervention for Adults With Diabetes and Emotional Distress

The University of Alabama at Birmingham

Status: Completed

Conditions: Type 2 Diabetes; Stress

Treatments: Behavioral: Integrated MBSR/DSME intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03987841

IRB-300003578

KL2TR003097 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

We will conduct a single-arm pilot study of an integrated mindfulness-based stress reduction (MBSR)/diabetes self-management education (DSME) intervention in a small group of participants, low-income adults with type 2 diabetes and diabetes distress. We will evaluate the preliminary efficacy, acceptability, and feasibility of the intervention.

Full description

The intervention will comprise components of MBSR and DSME and will be delivered in a group setting with 8 weekly sessions. We anticipate enrollment of 30 participants, who will be adults with poorly controlled type 2 diabetes and elevated diabetes distress recruited from Cooper Green Mercy Health Systems, a safety-net health system serving residents of Jefferson County, Alabama. A trained masters-level interventionist will deliver the integrated intervention. The aim of the intervention is to reduce diabetes distress and improve glycemic control.

Participants will be assessed at baseline and 2 months. We will assess the preliminary efficacy of the intervention through pre/post evaluation of diabetes distress, diabetes self-management behaviors, and glycemic control as measured by hemoglobin A1c. Additionally, we will assess acceptability of the intervention through follow-up qualitative, focus groups with intervention participants; the feasibility of intervention delivery will be assessed using process measures.

Enrollment: 5 patients

Sex: All

Ages: 19 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Receipt of care at Cooper Green Mercy Healthcare System (CGMHS), one or more visits to primary care or diabetes clinic within the prior year
• An elevated point-of-care hemoglobin A1c (A1C) ≥7.5
• Presence of moderate diabetes distress (indicated by a score of ≥2 on the Diabetes Distress Scale)

Exclusion criteria

• Non-English speaking
• Currently pregnant
• Personal history or prior diagnosis of bipolar disorder, schizophrenia, or psychosis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Integrated MBSR/DSME intervention

Experimental group

Description:

Integrated mindfulness-based stress reduction/diabetes self-management education intervention. Single-arm study, a group of participants meeting eligibility requirements will be invited to participate.

Treatment:

Behavioral: Integrated MBSR/DSME intervention