Clinical trial NCT03987841: Intervention Mapping to Adapt a Mindfulness-based Intervention for Adults With Diabetes and Emotional Distress
Official title: Intervention Mapping to Adapt a Mindfulness-based Intervention for Adults With Diabetes and Emotional Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Stress
Keywords: Diabetes distress
Mindfulness-based intervention
Diabetes self-management education
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-06-17
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diabetes Distress
timeFrame: Baseline
measure: Diabetes Distress
timeFrame: 2-months
measure: Hemoglobin A1c (A1C)
timeFrame: Baseline
measure: Hemoglobin A1c (A1C)
timeFrame: 2-months
Secondary outcomes:
measure: Diabetes Self-management Behaviors
timeFrame: Baseline
measure: Diabetes Self-management Behaviors
timeFrame: 2-months
measure: Medication Adherence
timeFrame: Baseline
measure: Medication Adherence
timeFrame: 2-months
measure: Acceptability of the Intervention to Participants: Semi-structured Interviews
timeFrame: 2-months
measure: Feasibility: Percentage of Screened Participants Who Are Eligible
timeFrame: Baseline
measure: Feasibility: Percentage of Eligible Participants Who Enroll
timeFrame: Baseline
measure: Feasibility: Distribution of Participants by Demographics
timeFrame: Baseline
measure: Feasibility: Percentage of Sessions Attended
timeFrame: 2-months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cooper Green Mercy Health Systems
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Caroline A Presley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: