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

NCT03987841 | Completed Results

• 2 other identifiers: IRB-300003578KL2TR003097
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Stress

Keywords

Diabetes distress; Mindfulness-based intervention; Diabetes self-management education

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (9)

• Diabetes Self-management Behaviors

  Baseline

• Diabetes Self-management Behaviors

  2-months

• Medication Adherence

  Baseline

• Medication Adherence

  2-months

• Acceptability of the Intervention to Participants: Semi-structured Interviews

  2-months

Study Arms (1)

Integrated MBSR/DSME intervention

EXPERIMENTAL

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

Interventions

Integrated MBSR/DSME intervention BEHAVIORAL

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.

Integrated MBSR/DSME intervention

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Cooper Green Mercy Health Systems

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

We experienced limitations in recruiting participants and delays in conducting the trial related to COVID (including interruptions in in-person care related to COVID). These factors resulted in smaller study sample than planned.

Results Point of Contact

• Title: Caroline Presley
• Organization: University of Alabama at Birmingham

capresley@uabmc.edu

205-934-7609

Study Officials

• Caroline A Presley, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: October 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2022
• Last Updated: November 2, 2023
• Results First Posted: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)