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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03987841
Enrollment
5
Registered
2019-06-17
Start date
2021-10-01
Completion date
2022-06-30
Last updated
2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress, Type 2 Diabetes

Keywords

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

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.

Interventions

BEHAVIORALIntegrated 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.

Sponsors

National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 64 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Diabetes DistressBaselineMeasured 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.
Hemoglobin A1c (A1C)BaselineParticipants 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.

Secondary

MeasureTime frameDescription
Acceptability of the Intervention to Participants: Semi-structured Interviews2-monthsAcceptability 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.
Feasibility: Percentage of Screened Participants Who Are EligibleBaselineWe 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.
Diabetes Self-management BehaviorsBaselineMeasured 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.
Feasibility: Distribution of Participants by DemographicsBaselineWe 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.
Feasibility: Percentage of Sessions Attended2-monthsWe will track the number of sessions attended by each participant and calculate the percentage of overall sessions attended for each participant.
Feasibility: Percentage of Eligible Participants Who EnrollBaselineWe 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.
Medication AdherenceBaselineParticipants 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
5
Total5

Baseline characteristics

CharacteristicIntegrated MBSR/DSME Intervention
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
Age, Continuous54 years
STANDARD_DEVIATION 6.78
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
1 Participants
Region of Enrollment
United States
5 participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 5
other
Total, other adverse events
0 / 5
serious
Total, serious adverse events
0 / 5

Outcome results

Primary

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Integrated MBSR/DSME InterventionDiabetes Distress2.64 score on a scaleStandard Deviation 0.94
Primary

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.

Time frame: 2-months

ArmMeasureValue (MEAN)Dispersion
Integrated MBSR/DSME InterventionDiabetes Distress2.19 score on a scaleStandard Deviation 0.68
Primary

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Integrated MBSR/DSME InterventionHemoglobin A1c (A1C)7.14 percentage of glycosylated hemoglobinStandard Deviation 0.88
Primary

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.

Time frame: 2-months

ArmMeasureValue (MEAN)Dispersion
Integrated MBSR/DSME InterventionHemoglobin A1c (A1C)7.24 percentage of glycosylated hemoglobinStandard Deviation 0.98
Secondary

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.

Time frame: 2-months

Population: Not calculable value, based on qualitative analysis intervention acceptable to participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Integrated MBSR/DSME InterventionAcceptability of the Intervention to Participants: Semi-structured InterviewsHandouts and study materials were easy to understand and useful for participants5 Participants
Integrated MBSR/DSME InterventionAcceptability of the Intervention to Participants: Semi-structured InterviewsParticipants made changes related to mindful eating, physical activity, and managing stress5 Participants
Integrated MBSR/DSME InterventionAcceptability of the Intervention to Participants: Semi-structured InterviewsParticipants reported main challenge was finding time to do activities outside of study sessions5 Participants
Integrated MBSR/DSME InterventionAcceptability of the Intervention to Participants: Semi-structured InterviewsParticipant suggestion: more clearly linking discussions about stress and diabetes management5 Participants
Integrated MBSR/DSME InterventionAcceptability of the Intervention to Participants: Semi-structured InterviewsParticipant suggestion: include more examples and opportunities to practice exercises5 Participants
Integrated MBSR/DSME InterventionAcceptability of the Intervention to Participants: Semi-structured InterviewsParticipant suggestion: include multiple methods to access guidance for home practices5 Participants
Integrated MBSR/DSME InterventionAcceptability of the Intervention to Participants: Semi-structured InterviewsOverall satisfaction with program was high5 Participants
Secondary

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.

Time frame: 2-months

ArmMeasureGroupValue (MEAN)Dispersion
Integrated MBSR/DSME InterventionDiabetes Self-management BehaviorsDiet4.4 units on a scaleStandard Deviation 1.47
Integrated MBSR/DSME InterventionDiabetes Self-management BehaviorsExercise3.1 units on a scaleStandard Deviation 1.82
Integrated MBSR/DSME InterventionDiabetes Self-management BehaviorsBlood Glucose4.7 units on a scaleStandard Deviation 2.2
Integrated MBSR/DSME InterventionDiabetes Self-management BehaviorsFoot Care5.4 units on a scaleStandard Deviation 2.5
Secondary

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.

Time frame: Baseline

ArmMeasureGroupValue (MEAN)Dispersion
Integrated MBSR/DSME InterventionDiabetes Self-management BehaviorsExercise3.4 units on a scaleStandard Deviation 2.36
Integrated MBSR/DSME InterventionDiabetes Self-management BehaviorsBlood Glucose3.8 units on a scaleStandard Deviation 2.41
Integrated MBSR/DSME InterventionDiabetes Self-management BehaviorsDiet3.96 units on a scaleStandard Deviation 1.54
Integrated MBSR/DSME InterventionDiabetes Self-management BehaviorsFoot Care6.3 units on a scaleStandard Deviation 1.57
Secondary

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.

Time frame: Baseline

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Integrated MBSR/DSME InterventionFeasibility: Distribution of Participants by DemographicsNon-Hispanic white male1 Participants
Integrated MBSR/DSME InterventionFeasibility: Distribution of Participants by DemographicsNon-Hispanic Black female3 Participants
Integrated MBSR/DSME InterventionFeasibility: Distribution of Participants by DemographicsNon-Hispanic Black male1 Participants
Secondary

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.

Time frame: Baseline

Population: This is the number of eligible participants.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Integrated MBSR/DSME InterventionFeasibility: Percentage of Eligible Participants Who Enroll5 Participants
Secondary

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.

Time frame: Baseline

Population: This was total number of participants screened for eligibility.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Integrated MBSR/DSME InterventionFeasibility: Percentage of Screened Participants Who Are Eligible11 Participants
Secondary

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.

Time frame: 2-months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Integrated MBSR/DSME InterventionFeasibility: Percentage of Sessions Attended100% attendance3 Participants
Integrated MBSR/DSME InterventionFeasibility: Percentage of Sessions Attended85% attendance1 Participants
Integrated MBSR/DSME InterventionFeasibility: Percentage of Sessions Attended71% attendance1 Participants
Secondary

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Integrated MBSR/DSME InterventionMedication Adherence17 score on a scaleStandard Deviation 9.54
Secondary

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.

Time frame: 2-months

ArmMeasureValue (MEAN)Dispersion
Integrated MBSR/DSME InterventionMedication Adherence16.2 score on a scaleStandard Deviation 5.17

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026