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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03987841
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
8
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Integrated MBSR/DSME intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intervention Mapping to Adapt a Mindfulness-based Intervention for Adults With Diabetes and Emotional Distress
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Diabetes distress [Baseline]

    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. Diabetes distress [2-months]

    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.

  3. Hemoglobin A1c (A1C) [Baseline]

    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.

  4. Hemoglobin A1c (A1C) [2-months]

    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.

Secondary Outcome Measures

  1. Diabetes self-management behaviors [Baseline]

    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. Diabetes self-management behaviors [2-months]

    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.

  3. Medication adherence [Baseline]

    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.

  4. Medication adherence [2-months]

    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.

  5. Acceptability of the intervention to participants: semi-structured interviews [2-months]

    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.

  6. Feasibility: percentage of screened participants who are eligible [Baseline]

    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.

  7. Feasibility: percentage of eligible participants who enroll [Baseline]

    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.

  8. Feasibility: distribution of participants by demographics [Baseline]

    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.

  9. Feasibility: percentage of sessions attended [2-months]

    We will track the number of sessions attended by each participant and calculate the percentage of overall sessions attended for each participant.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Cooper Green Mercy Health SystemsBirminghamAlabamaUnited States35233

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

  • Principal Investigator: Caroline A Presley, MD, MPH, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Caroline Presley, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT03987841
Other Study ID Numbers:
  • IRB-300003578
First Posted:
Jun 17, 2019
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Caroline Presley, Principal Investigator, University of Alabama at Birmingham
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2021