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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Integrated MBSR/DSME 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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrated MBSR/DSME intervention; 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.	Behavioral: Integrated MBSR/DSME intervention; Integrated mindfulness-based stress reduction/diabetes self-management education intervention. The intervention will comprise components of MBSR and DSME and will be delivered in a group setting with 8 weekly sessions. A trained masters-level interventionist will deliver the integrated intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c (A1C)	Participants will have a point-of-care A1C measured; A1C will be obtained by trained study personnel using finger-stick testing with the A1C Now+20 Test Kit (PTS diagnostics). A1C reports a % glycated hemoglobin level; a higher score indicates higher average blood glucose levels over the preceding 3 months. An A1C greater than or equal to 7.5% indicates poorly controlled type 2 diabetes.	Baseline
Hemoglobin A1c (A1C)	Participants will have a point-of-care A1C measured; A1C will be obtained by trained study personnel using finger-stick testing with the A1C Now+20 Test Kit (PTS diagnostics). 1C reports a % glycated hemoglobin level; a higher score indicates higher average blood glucose levels over the preceding 3 months. An A1C greater than or equal to 7.5% indicates poorly controlled type 2 diabetes.	2-months
Diabetes Distress	Measured by the diabetes distress scale (DDS), a 17-item self-report measure, assessing domains of emotional burden, physician-related distress, regimen-related distress, and interpersonal distress. The questionnaire will be administered to participants in English by a trained interviewer. The mean item score yields a possible score from 1 to 6; a score of <2 indicates little/no distress, 2 to 2.9 moderate distress, and ≥3 high distress.	Baseline
Diabetes Distress	Measured by the diabetes distress scale (DDS), a 17-item self-report measure, assessing domains of emotional burden, physician-related distress, regimen-related distress, and interpersonal distress. The questionnaire will be administered to participants in English by a trained interviewer. The mean item score yields a possible score from 1 to 6; a score of <2 indicates little/no distress, 2 to 2.9 moderate distress, and ≥3 high distress.	2-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Self-management Behaviors	Measured by the Summary of Diabetes Self-Care Activities (SDSCA), a 10-item self-report measure that assesses diet (4-items), exercise (2-items), blood-glucose testing (2-items), and foot care (2-items). An example item is "How many of the last seven days have you followed a healthful eating plan?" Participants respond based on their self-care experience for the preceding week, from 0 to 7 indicating the number of days the participant performed the behavior. Each subscale is scored separately and scores are not combined. For each subscale, the score is the mean item score (i.e. mean number of days the activity was performed, range 0-7). A higher score indicates higher adherence to the self-care behavior. The questionnaire will be administered to participants in English by a trained interviewer.	Baseline
Diabetes Self-management Behaviors	Measured by the Summary of Diabetes Self-Care Activities (SDSCA), a 10-item self-report measure that assesses diet (4-items), exercise (2-items), blood-glucose testing (2-items), and foot care (2-items). An example item is "How many of the last seven days have you followed a healthful eating plan?" Participants respond based on their self-care experience for the preceding week, from 0 to 7 indicating the number of days the participant performed the behavior. Each subscale is scored separately and scores are not combined. For each subscale, the score is the mean item score (i.e. mean number of days the activity was performed, range 0-7). A higher score indicates higher adherence to the self-care behavior. The questionnaire will be administered to participants in English by a trained interviewer.	2-months
Medication Adherence	Participants will complete the Adherence to Refills and Medications - Diabetes (ARMS-D), an 11-item, self-report measure that includes medication-taking and refill subscales. Example item is "How often do you forget to take your diabetes medicine(s)?" Participants respond on a 4-point Likert scale from 1="none of the time" to 4="all of the time." Item responses are summed, combining subscales, yielding scores ranging from 11 to 44 (higher scores indicate greater difficulty with medication adherence). The questionnaire will be administered to participants in English by a trained interviewer.	Baseline
Medication Adherence	Participants will complete the Adherence to Refills and Medications - Diabetes (ARMS-D), an 11-item, self-report measure that includes medication-taking and refill subscales. Example item is "How often do you forget to take your diabetes medicine(s)?" Participants respond on a 4-point Likert scale from 1="none of the time" to 4="all of the time." Item responses are summed, combining subscales, yielding scores ranging from 11 to 44 (higher scores indicate greater difficulty with medication adherence). The questionnaire will be administered to participants in English by a trained interviewer.	2-months
Acceptability of the Intervention to Participants: Semi-structured Interviews	Acceptability will be assessed by conducting qualitative, semi-structured interviews with participants at the conclusion of the intervention. The interviews will gather participants' perspectives on the following: assessment of intervention content, perceived positive or negative effects, appropriateness of intervention duration and frequency, barriers to engagement, suggestions to improve the intervention, and overall satisfaction. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.	2-months
Feasibility: Percentage of Screened Participants Who Are Eligible	We will assess the percentage of screened participants who are eligible to participate in the study. Study staff will track the number of participants who are screened for participation and the number of participants who are eligible to participate.	Baseline
Feasibility: Percentage of Eligible Participants Who Enroll	We will assess the percentage of eligible participants who enroll in the study. Study staff will track the number of participants who are eligible for participation and the number of participants who enroll in the study.	Baseline
Feasibility: Distribution of Participants by Demographics	We will collect demographics of study participants including age, race, ethnicity, and gender by participant self-report. This information will be obtained during a questionnaire administered to participants in English by a trained interviewer. We will use descriptive statistics to characterize the demographics of the study sample.	Baseline
Feasibility: Percentage of Sessions Attended	We will track the number of sessions attended by each participant and calculate the percentage of overall sessions attended for each participant.	2-months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Caroline A Presley, MD, MPH, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes distress; Mindfulness-based intervention; Diabetes self-management education
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: IRB-300003578; KL2TR003097 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No