Stress, Type 2 Diabetes
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 5 |
Baseline characteristics
| Characteristic | Integrated 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, Continuous | 54 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 type | EG000 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
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated MBSR/DSME Intervention | Diabetes Distress | 2.64 score on a scale | Standard Deviation 0.94 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated MBSR/DSME Intervention | Diabetes Distress | 2.19 score on a scale | Standard Deviation 0.68 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated MBSR/DSME Intervention | Hemoglobin A1c (A1C) | 7.14 percentage of glycosylated hemoglobin | Standard Deviation 0.88 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated MBSR/DSME Intervention | Hemoglobin A1c (A1C) | 7.24 percentage of glycosylated hemoglobin | Standard Deviation 0.98 |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Integrated MBSR/DSME Intervention | Acceptability of the Intervention to Participants: Semi-structured Interviews | Handouts and study materials were easy to understand and useful for participants | 5 Participants |
| Integrated MBSR/DSME Intervention | Acceptability of the Intervention to Participants: Semi-structured Interviews | Participants made changes related to mindful eating, physical activity, and managing stress | 5 Participants |
| Integrated MBSR/DSME Intervention | Acceptability of the Intervention to Participants: Semi-structured Interviews | Participants reported main challenge was finding time to do activities outside of study sessions | 5 Participants |
| Integrated MBSR/DSME Intervention | Acceptability of the Intervention to Participants: Semi-structured Interviews | Participant suggestion: more clearly linking discussions about stress and diabetes management | 5 Participants |
| Integrated MBSR/DSME Intervention | Acceptability of the Intervention to Participants: Semi-structured Interviews | Participant suggestion: include more examples and opportunities to practice exercises | 5 Participants |
| Integrated MBSR/DSME Intervention | Acceptability of the Intervention to Participants: Semi-structured Interviews | Participant suggestion: include multiple methods to access guidance for home practices | 5 Participants |
| Integrated MBSR/DSME Intervention | Acceptability of the Intervention to Participants: Semi-structured Interviews | Overall satisfaction with program was high | 5 Participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated MBSR/DSME Intervention | Diabetes Self-management Behaviors | Diet | 4.4 units on a scale | Standard Deviation 1.47 |
| Integrated MBSR/DSME Intervention | Diabetes Self-management Behaviors | Exercise | 3.1 units on a scale | Standard Deviation 1.82 |
| Integrated MBSR/DSME Intervention | Diabetes Self-management Behaviors | Blood Glucose | 4.7 units on a scale | Standard Deviation 2.2 |
| Integrated MBSR/DSME Intervention | Diabetes Self-management Behaviors | Foot Care | 5.4 units on a scale | Standard Deviation 2.5 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated MBSR/DSME Intervention | Diabetes Self-management Behaviors | Exercise | 3.4 units on a scale | Standard Deviation 2.36 |
| Integrated MBSR/DSME Intervention | Diabetes Self-management Behaviors | Blood Glucose | 3.8 units on a scale | Standard Deviation 2.41 |
| Integrated MBSR/DSME Intervention | Diabetes Self-management Behaviors | Diet | 3.96 units on a scale | Standard Deviation 1.54 |
| Integrated MBSR/DSME Intervention | Diabetes Self-management Behaviors | Foot Care | 6.3 units on a scale | Standard Deviation 1.57 |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Integrated MBSR/DSME Intervention | Feasibility: Distribution of Participants by Demographics | Non-Hispanic white male | 1 Participants |
| Integrated MBSR/DSME Intervention | Feasibility: Distribution of Participants by Demographics | Non-Hispanic Black female | 3 Participants |
| Integrated MBSR/DSME Intervention | Feasibility: Distribution of Participants by Demographics | Non-Hispanic Black male | 1 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Integrated MBSR/DSME Intervention | Feasibility: Percentage of Eligible Participants Who Enroll | 5 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Integrated MBSR/DSME Intervention | Feasibility: Percentage of Screened Participants Who Are Eligible | 11 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Integrated MBSR/DSME Intervention | Feasibility: Percentage of Sessions Attended | 100% attendance | 3 Participants |
| Integrated MBSR/DSME Intervention | Feasibility: Percentage of Sessions Attended | 85% attendance | 1 Participants |
| Integrated MBSR/DSME Intervention | Feasibility: Percentage of Sessions Attended | 71% attendance | 1 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated MBSR/DSME Intervention | Medication Adherence | 17 score on a scale | Standard Deviation 9.54 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated MBSR/DSME Intervention | Medication Adherence | 16.2 score on a scale | Standard Deviation 5.17 |