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

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ClinicalTrials.gov Identifier: NCT03987841
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Caroline Presley, University of Alabama at Birmingham

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 disease Intervention/treatment Phase
Type 2 Diabetes Stress Behavioral: Integrated MBSR/DSME intervention Not Applicable

Detailed Description:

The intervention will comprise components of MBSR and DSME and will be delivered in a group setting with 12 weekly sessions followed by monthly spaced reminders for 3 months for a total duration of 6 months. 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 6-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, semi-structured interviews of intervention participants; the feasibility of intervention delivery will be assessed using process measures.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


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 12 weekly sessions followed by monthly spaced reminders for 3 months (6 months total). A trained masters-level interventionist will deliver the integrated intervention.




Primary Outcome Measures :
  1. Diabetes distress [ Time Frame: 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 [ Time Frame: 6-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) [ Time Frame: 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) [ Time Frame: 6-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 [ Time Frame: 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 [ Time Frame: 6-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 [ Time Frame: 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 [ Time Frame: 6-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 [ Time Frame: 6-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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6-months ]
    We will track the number of sessions attended by each participant and calculate the percentage of overall sessions attended for each participant.



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987841


Contacts
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Contact: Caroline A Presley, MD, MPH 205-934-7609 capresley@uabmc.edu

Locations
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United States, Alabama
Cooper Green Mercy Health Systems Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Reagan Durant, MD, MPH         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Caroline A Presley, MD, MPH University of Alabama at Birmingham

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Responsible Party: Caroline Presley, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03987841     History of Changes
Other Study ID Numbers: IRB-300003578
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Caroline Presley, University of Alabama at Birmingham:
Diabetes distress
Mindfulness-based intervention
Diabetes self-management education

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases