Type 2 DiabetesNCT05195138
Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress
A study testing Mindfulness-Based Diabetes Education and Standard Diabetes Self-Management Education (DSME) in people with Type 2 Diabetes, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Diabetes distress is common affecting over one-third of people with type 2 diabetes, negatively impacting self-management and outcomes, and disproportionately affecting low-income individuals. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Mindfulness-Based Diabetes Education and Standard Diabetes Self-Management Education (DSME)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-70 years
- Diagnosis of type 2 diabetes (based on the presence of two or more outpatient International Classification of Diseases (ICD-10) codes for type 2 diabetes
- Receipt of care at Cooper Green Mercy Health Systems Authority or Alabama Regional Medical Services (one or more visits to primary care or diabetes clinic within the prior year
- Presence of moderate-severe diabetes distress (score ≥2 on Diabetes Distress Scale
- Suboptimal glycemic control (elevated hemoglobin A1c (A1C) ≥7.5%)
Who cannot join
- Non-English speaking
- Currently pregnant
- Diagnosis of severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis (based on participant self-report)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper Green Mercy Health Systems
Birmingham, Alabama, 35233
About this study
Diabetes distress is common affecting over one-third of people with type 2 diabetes, negatively impacting self-management and outcomes, and disproportionately affecting low-income individuals. The proposed project will conduct a pilot randomized controlled trial comparing Mindfulness-Based Diabetes Education to standard Diabetes Self-Management Education in adults with type 2 diabetes and elevated diabetes distress who receive care within safety-net healthcare systems in order to assess feasibility and acceptability.
Read the detailed description
The investigators will conduct a pilot randomized controlled trial (RCT) of Mindfulness-Based Diabetes Education (MBDE) versus standard Diabetes Self-Management Education (DSME) in adults with type 2 diabetes and moderate-severe diabetes distress who receive their care from safety-net healthcare systems. The goal of this pilot RCT will be to assess the acceptability and feasibility of MBDE; acceptability will be assessed through qualitative follow-up interviews with participants and feasibility will be assessed through process measures. The investigators will recruit up to approximately 96 participants, 48 from each site to account for potential loss to follow up of up to 20%, for the study with total study duration of 6 months. Participants will be randomized 1:1 to each study arm. This study will also serve as a pilot test for the procedures of the RCT and of measures to be used in participant assessments.
The study will be conducted at two safety-net clinics that provide care for residents of Jefferson County using a sliding scale program based on income level - Cooper Green Mercy Health Services Authority (CGMHSA) and Alabama Regional Medicine Services (ARMS). CGMHSA, an affiliate of University of Alabama at Birmingham (UAB) Health System, is Jefferson County's public safety-net health care facility. CGMHSA provides care primarily to the indigent county residents, geographically spanning most of the Birmingham metropolitan area. Ambulatory care services are provided to patients who have type 2 diabetes through Cooper Green's Primary Care Clinic and multi-disciplinary Diabetes Clinic. ARMS is a Community Health Center serving the greater Birmingham area since 1983. ARMS provides ambulatory care for adults, including primary care, diabetes self-management education classes, and behavioral health services. ARMS offers services to patients, with or without insurance, on a sliding scale fee program based on income.
Trained study staff overseen by the study PI will recruit participants from CGMHSA and ARMS through three methods. Opt-out letters will be mailed to patients seen at CGMHSA or ARMS in the preceding three years with a diagnosis of type 2 diabetes; study staff will then call potential participants to provide more information about the study and to gauge their interest in participating. The investigators will obtain a HIPAA waiver to access potential participant information from the medical record in order to generate a recruitment list. The investigators will also conduct in-person recruitment of participants at CGMHSA and ARMS, as well as direct referral of potential participants by providers or patients. Trained study personnel will obtain screening consent from potential participants prior to screening for eligibility based on inclusion and exclusion criteria, which will include assessment of diabetes distress and hemoglobin A1c (A1C) through point-of-care (POC) finger-stick sample. Study staff will then obtain informed consent from eligible participants at the time of enrollment.
Both MDBE and standard DSME study arms will be delivered in-person, in a group setting with 10-14 participants per group. MBDE will be delivered in 8 weekly group sessions followed by 2 bimonthly individual, booster sessions conducted by phone for a total duration of 6 months. MBDE will be delivered by an interventionist with a background in nursing and training as an MBSR instructor, who will receive additional training in MBDE with an emphasis on content drawn from DSME. Standard DSME will be delivered by a certified diabetes educator in eight weekly sessions of 2 hours duration. Sessions will cover seven core content areas - healthy eating, physical activity, medication usage, self-monitoring, preventing and treating acute and chronic complications, healthy coping, and problem solving.
Total study duration will be six months; a trained study staff will complete assessments of participants in both study arms at baseline, 2 months, and 6 months. Participants in both study arms will complete assessments that will be conducted by trained study personnel, including interviewer-administered questionnaire, biometric assessment (height, weight, blood pressure), and POC A1C testing from a finger-stick sample at 3 time points - baseline, 2 months, and 6 months. Participants in the MBDE arm will be asked to participate in a focus group (estimated length 1 hour) at the 2 month time point. Participants will receive an incentive for their participation for each study assessment and for participation in a focus group.
- Conditions
- Type 2 Diabetes
- Being tested
- Mindfulness-Based Diabetes Education, Standard Diabetes Self-Management Education (DSME)
- Keywords
- Diabetes distress, Mindfulness-based diabetes education
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Diabetes EducationBehavioural
Mindfulness-Based Diabetes Education described in study arm.
Standard Diabetes Self-Management Education (DSME)Behavioural
Standard DSME described in study arm.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Diabetes Education | Experimental | Mindfulness-Based Diabetes Education (MBDE) will be delivered in-person in a group of 10-14 participants during 8 weekly sessions followed by 2 bimonthly individual sessions. Sessions integrate Mindfulness-Based Stress Reduction and Diabetes Self-Management Education. MBDE will introduce breath awareness meditation, body scan, walking meditation, mindful yoga, and applying mindfulness to daily activities, as well as core areas from DSME. MBDE will include incremental goal setting to build participants' self-efficacy for diabetes self-management behaviors, mindful attention to diabetes self-management, and on development of social support in the group. Participants will complete daily home mindfulness exercises and self-monitoring of diabetes self-management behaviors. Receives: Behavioral: Mindfulness-Based Diabetes Education |
| Standard Diabetes Self-Management Education | Active comparator | Standard DSME will be delivered in-person, in a group setting with 10-14 participants per group. Standard DSME will be delivered by a certified diabetes educator in eight weekly sessions of 2 hours duration. Sessions will cover seven core content areas - healthy eating, physical activity, medication usage, self-monitoring, preventing and treating acute and chronic complications, healthy coping, and problem solving. Receives: Behavioral: Standard Diabetes Self-Management Education (DSME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant assessment of perceived positive and negative effects
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.
Measured: 2 months
Participant assessment of intervention content
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.
Measured: 2 months
Participant assessment of appropriateness of intervention duration and frequency
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.
Measured: 2 months
Participant satisfaction with interventionist
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.
Measured: 2 months
Participant-reported barriers to engagement with the intervention sessions or content
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.
Measured: 2 months
Participants' suggestions to improve the intervention
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.
Measured: 2 months
Participants' overall satisfaction with the intervention
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.
Measured: 2 months
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.
Measured: 6 months
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.
Measured: 6 months
Feasibility: ability to randomize participants to study arms
We will assess the percentage of eligible participants who are randomized. Study staff will track the number of participants who are enrolled and the number of participants who are randomized.
Measured: 6 months
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.
Measured: 6 months
Feasibility: percentage of sessions attended
We will track the number of sessions attended by each participant and calculate the percentage of sessions attended by each participant.
Measured: 6 months
Feasibility: participant adherence to study tasks include home mindfulness practices, self-monitoring activities
At each session, we will collect logs of participants' home mindfulness and self-monitoring activities. We will calculate participant adherence to recommended activities for each participant.
Measured: 6 months
Feasibility: barriers to participation in intervention sessions or completing study activities at home
We will collect information from participants to assess any barriers they experienced attending study sessions or completing recommended home activities. This information will be obtained during a questionnaire administered to participants in English by a trained interviewer.
Measured: 6 months
Feasibility: reasons for dropping out
We will collect information from participants who drop out of the intervention or study regarding the reason for dropping out.
Measured: 6 months
Feasibility: overall study retention
We will track the number of participants who enroll in the study and complete assessments at each time point - baseline, 2 months, and 6 months.
Measured: 6 months
Secondary outcomes (38)
Hemoglobin 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+ Test Kits (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.
Measured: Baseline
Hemoglobin 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+ Test Kits (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.
Measured: 6 months
Diabetes distress
Participants will complete 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 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. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: Baseline
Diabetes distress
Participants will complete 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 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. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 2 months
Diabetes distress
Participants will complete 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 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. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 6 months
Diabetes self-management behaviors
Participants will complete the Diabetes Self-Management Questionnaire, a 16-item self-report measure that assesses dietary control, blood glucose monitoring, physical activity, and healthcare use. Participants respond on a 4-point Likert scale from 0 "does not apply to me" to 3 "applies to me very much" referring to the preceding 8 weeks. Responses are summed and transformed to a 10-point scale with a higher score indicating higher adherence to the score. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: Baseline
Diabetes self-management behaviors
Participants will complete the Diabetes Self-Management Questionnaire, a 16-item self-report measure that assesses dietary control, blood glucose monitoring, physical activity, and healthcare use. Participants respond on a 4-point Likert scale from 0 "does not apply to me" to 3 "applies to me very much" referring to the preceding 8 weeks. Responses are summed and transformed to a 10-point scale with a higher score indicating higher adherence to the score. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 2 months
Diabetes self-management behaviors
Participants will complete the Diabetes Self-Management Questionnaire, a 16-item self-report measure that assesses dietary control, blood glucose monitoring, physical activity, and healthcare use. Participants respond on a 4-point Likert scale from 0 "does not apply to me" to 3 "applies to me very much" referring to the preceding 8 weeks. Responses are summed and transformed to a 10-point scale with a higher score indicating higher adherence to the score. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 6 months
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 to yield a score from 11-44 (higher scores indicate greater difficulty with medication adherence). The questionnaire will be administered to participants in English by a trained interviewer.
Measured: Baseline
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 to yield a score from 11-44 (higher scores indicate greater difficulty with medication adherence). The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 2 months
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 to yield a score from 11-44 (higher scores indicate greater difficulty with medication adherence). The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 6 months
Mindfulness
Participants will complete the Five Facet Mindfulness Questionnaire (FFMQ), a 15-item self-report measure that assesses facets of observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Participants respond on a 5-point Likert scale from 1 "never or very rarely true" to 5 "very often or always true." Responses are summed, facet scores range from 3-15 with a higher score indicating higher levels of mindfulness.
Measured: Baseline
Mindfulness
Participants will complete the Five Facet Mindfulness Questionnaire (FFMQ), a 15-item self-report measure that assesses facets of observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Participants respond on a 5-point Likert scale from 1 "never or very rarely true" to 5 "very often or always true." Responses are summed, facet scores range from 3-15 with a higher score indicating higher levels of mindfulness.
Measured: 2 months
Mindfulness
Participants will complete the Five Facet Mindfulness Questionnaire (FFMQ), a 15-item self-report measure that assesses facets of observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Participants respond on a 5-point Likert scale from 1 "never or very rarely true" to 5 "very often or always true." Responses are summed, facet scores range from 3-15 with a higher score indicating higher levels of mindfulness.
Measured: 6 months
Emotion regulation
Participants will complete the Difficulties in Emotion Regulation Scale (DERS), an 18-item self-report measure that includes subscales on awareness, clarity, goals, impulse, nonacceptance, and strategy. Participants respond on a 5-point Likert scale from 1 "almost never" to 5 "almost always." Item responses are summed, into subscale and total scales; total scores can range from 18-90 (higher score indicates more difficulty with emotion regulation). The questionnaire will be administered to participants in English by a trained interviewer.
Measured: Baseline
Emotion regulation
Participants will complete the Difficulties in Emotion Regulation Scale (DERS), an 18-item self-report measure that includes subscales on awareness, clarity, goals, impulse, nonacceptance, and strategy. Participants respond on a 5-point Likert scale from 1 "almost never" to 5 "almost always." Item responses are summed, into subscale and total scales; total scores can range from 18-90 (higher score indicates more difficulty with emotion regulation). The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 2 months
Emotion regulation
Participants will complete the Difficulties in Emotion Regulation Scale (DERS), an 18-item self-report measure that includes subscales on awareness, clarity, goals, impulse, nonacceptance, and strategy. Participants respond on a 5-point Likert scale from 1 "almost never" to 5 "almost always." Item responses are summed, into subscale and total scales; total scores can range from 18-90 (higher score indicates more difficulty with emotion regulation). The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 6 months
Self-awareness
Participants will complete the Multidimensional Assessment of Interoceptive Awareness, a 37-item self-report measure that includes subscales on noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Participants respond of a 6-point Likert scale from 0 "never to 5 "always." Mean item scores for each subscale are obtained. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: Baseline
Self-awareness
Participants will complete the Multidimensional Assessment of Interoceptive Awareness, a 37-item self-report measure that includes subscales on noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Participants respond of a 6-point Likert scale from 0 "never to 5 "always." Mean item scores for each subscale are obtained. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 2 months
Self-awareness
Participants will complete the Multidimensional Assessment of Interoceptive Awareness, a 37-item self-report measure that includes subscales on noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Participants respond of a 6-point Likert scale from 0 "never to 5 "always." Mean item scores for each subscale are obtained. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 6 months
Self-efficacy as assessed by the Perceived Diabetes Self-Management Scale (PDSMS)
Participants will complete the PDSMS, an 8-item self-report measure that assesses the degree to which participants feel confident to perform their diabetes self-management behaviors. Participants respond on a 5-point Likert scale from 1 "strongly disagree" to 5 "strongly agree." Items are summed; possible scores range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: Baseline
Self-efficacy as assessed by the Perceived Diabetes Self-Management Scale (PDSMS)
Participants will complete the PDSMS, an 8-item self-report measure that assesses the degree to which participants feel confident to perform their diabetes self-management behaviors. Participants respond on a 5-point Likert scale from 1 "strongly disagree" to 5 "strongly agree." Items are summed; possible scores range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 2 months
Self-efficacy as assessed by the Perceived Diabetes Self-Management Scale (PDSMS)
Participants will complete the PDSMS, an 8-item self-report measure that assesses the degree to which participants feel confident to perform their diabetes self-management behaviors. Participants respond on a 5-point Likert scale from 1 "strongly disagree" to 5 "strongly agree." Items are summed; possible scores range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 6 months
Social support
Participants will complete the 6-item Social Support Questionnaire. For each item, respondents first list the number of individuals available for support in specific circumstances, and then indicate their level of satisfaction with that support using a 6-point Likert-type scale from 1 "dissatisfied" to 6 "very satisfied." The means of the two parts are obtained separately to indicate mean number of social supports and mean satisfaction with social support. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: Baseline
Social support
Participants will complete the 6-item Social Support Questionnaire. For each item, respondents first list the number of individuals available for support in specific circumstances, and then indicate their level of satisfaction with that support using a 6-point Likert-type scale from 1 "dissatisfied" to 6 "very satisfied." The means of the two parts are obtained separately to indicate mean number of social supports and mean satisfaction with social support. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 2 months
Social support
Participants will complete the 6-item Social Support Questionnaire. For each item, respondents first list the number of individuals available for support in specific circumstances, and then indicate their level of satisfaction with that support using a 6-point Likert-type scale from 1 "dissatisfied" to 6 "very satisfied." The means of the two parts are obtained separately to indicate mean number of social supports and mean satisfaction with social support. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 6 months
Perceived stress
Participants will complete the Perceived Stress Scale, a 10-item self-report measure that assesses how often a person has experienced thoughts and feelings related to perceived stress over the preceding 1 month. Participants respond on a 5-point Likert scale ranging from 0 "never" to 4 "almost always". Positively worded items are reverse scored, and the responses are summed yielding a score range of 0-40; higher scores indicate more perceived stress. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: Baseline
Perceived stress
Participants will complete the Perceived Stress Scale, a 10-item self-report measure that assesses how often a person has experienced thoughts and feelings related to perceived stress over the preceding 1 month. Participants respond on a 5-point Likert scale ranging from 0 "never" to 4 "almost always". Positively worded items are reverse scored, and the responses are summed yielding a score range of 0-40; higher scores indicate more perceived stress. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 2 months
Perceived stress
Participants will complete the Perceived Stress Scale, a 10-item self-report measure that assesses how often a person has experienced thoughts and feelings related to perceived stress over the preceding 1 month. Participants respond on a 5-point Likert scale ranging from 0 "never" to 4 "almost always". Positively worded items are reverse scored, and the responses are summed yielding a score range of 0-40; higher scores indicate more perceived stress. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 6 months
Depressive symptoms
Participants will complete the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form, an 8-item self-report measure that assesses depressive symptoms over the preceding 7 days Participants respond on a scale of 1 "never" to 5 "always." Responses are summed to yield a raw score from 8 to 40. Scores may be converted to a T score with score. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: Baseline
Depressive symptoms
Participants will complete the PROMIS Depression Short Form, an 8-item self-report measure that assesses depressive symptoms over the preceding 7 days Participants respond on a scale of 1 "never" to 5 "always." Responses are summed to yield a raw score from 8 to 40. Scores may be converted to a T score with score. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 2 months
Depressive symptoms
Participants will complete the PROMIS Depression Short Form, an 8-item self-report measure that assesses depressive symptoms over the preceding 7 days Participants respond on a scale of 1 "never" to 5 "always." Responses are summed to yield a raw score from 8 to 40. Scores may be converted to a T score with score. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 6 months
Anxiety
Participants will complete the PROMIS Anxiety Short Form an 7-item measure about feelings related to anxiety over the preceding 7 days. Participants respond on a 5-point Likert scale from 1 "never" to 5 "always." Responses are summed to yield a raw score from 7 to 35. Scores may be converted to a T score with score. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: Baseline
Anxiety
Participants will complete the PROMIS Anxiety Short Form an 7-item measure about feelings related to anxiety over the preceding 7 days. Participants respond on a 5-point Likert scale from 1 "never" to 5 "always." Responses are summed to yield a raw score from 7 to 35. Scores may be converted to a T score with score. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 2 months
Anxiety
Participants will complete the PROMIS Anxiety Short Form an 7-item measure about feelings related to anxiety over the preceding 7 days. Participants respond on a 5-point Likert scale from 1 "never" to 5 "always." Responses are summed to yield a raw score from 7 to 35. Scores may be converted to a T score with score. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 6 months
Type 2 diabetes stigma
Participants will complete the Type 2 Diabetes Stigma Assessment Scale, a 19-item self-report measure assessing domains of being treated differently, blame and judgment, and self-stigma subscales. Participants respond on a 5-point Likert scale from 1 "strongly disagree" to 5 "strongly agree." Item responses are summed to yield subscale and total scores; a higher score indicates presence of more stigma. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: Baseline
Type 2 diabetes stigma
Participants will complete the Type 2 Diabetes Stigma Assessment Scale, a 19-item self-report measure assessing domains of being treated differently, blame and judgment, and self-stigma subscales. Participants respond on a 5-point Likert scale from 1 "strongly disagree" to 5 "strongly agree." Item responses are summed to yield subscale and total scores; a higher score indicates presence of more stigma. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 2 months
Type 2 diabetes stigma
Participants will complete the Type 2 Diabetes Stigma Assessment Scale, a 19-item self-report measure assessing domains of being treated differently, blame and judgment, and self-stigma subscales. Participants respond on a 5-point Likert scale from 1 "strongly disagree" to 5 "strongly agree." Item responses are summed to yield subscale and total scores; a higher score indicates presence of more stigma. The questionnaire will be administered to participants in English by a trained interviewer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start31 May 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Presley, University of Alabama at Birmingham
- Investigators
- Caroline A Presley, MD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195138
- Sponsor's protocol ID
- IRB-300008617
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress
- ClinicalTrials.gov ID
- NCT05195138
- Acronym / sponsor ID
- IRB-300008617
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes distress, Mindfulness-based diabetes education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes distress is common affecting over one-third of people with type 2 diabetes, negatively impacting self-management and outcomes, and disproportionately affecting low-income individuals. The proposed project will conduct a pilot randomized controlled trial comparing Mindfulness-Based Diabetes Education to standard Diabetes Self-Management Education in adults with type 2 diabetes and elevated diabetes distress who receive care within safety-net healthcare systems in order to assess feasibility and acceptability.
Detailed description
The investigators will conduct a pilot randomized controlled trial (RCT) of Mindfulness-Based Diabetes Education (MBDE) versus standard Diabetes Self-Management Education (DSME) in adults with type 2 diabetes and moderate-severe diabetes distress who receive their care from safety-net healthcare systems. The goal of this pilot RCT will be to assess the acceptability and feasibility of MBDE; acceptability will be assessed through qualitative follow-up interviews with participants and feasibility will be assessed through process measures. The investigators will recruit up to approximately 96 participants, 48 from each site to account for potential loss to follow up of up to 20%, for the study with total study duration of 6 months. Participants will be randomized 1:1 to each study arm. This study will also serve as a pilot test for the procedures of the RCT and of measures to be used in participant assessments.
The study will be conducted at two safety-net clinics that provide care for residents of Jefferson County using a sliding scale program based on income level - Cooper Green Mercy Health Services Authority (CGMHSA) and Alabama Regional Medicine Services (ARMS). CGMHSA, an affiliate of University of Alabama at Birmingham (UAB) Health System, is Jefferson County's public safety-net health care facility. CGMHSA provides care primarily to the indigent county residents, geographically spanning most of the Birmingham metropolitan area. Ambulatory care services are provided to patients who have type 2 diabetes through Cooper Green's Primary Care Clinic and multi-disciplinary Diabetes Clinic. ARMS is a Community Health Center serving the greater Birmingham area since 1983. ARMS provides ambulatory care for adults, including primary care, diabetes self-management education classes, and behavioral health services. ARMS offers services to patients, with or without insurance, on a sliding scale fee program based on income.
Trained study staff overseen by the study PI will recruit participants from CGMHSA and ARMS through three methods. Opt-out letters will be mailed to patients seen at CGMHSA or ARMS in the preceding three years with a diagnosis of type 2 diabetes; study staff will then call potential participants to provide more information about the study and to gauge their interest in participating. The investigators will obtain a HIPAA waiver to access potential participant information from the medical record in order to generate a recruitment list. The investigators will also conduct in-person recruitment of participants at CGMHSA and ARMS, as well as direct referral of potential participants by providers or patients. Trained study personnel will obtain screening consent from potential participants prior to screening for eligibility based on inclusion and exclusion criteria, which will include assessment of diabetes distress and hemoglobin A1c (A1C) through point-of-care (POC) finger-stick sample. Study staff will then obtain informed consent from eligible participants at the time of enrollment.
Both MDBE and standard DSME study arms will be delivered in-person, in a group setting with 10-14 participants per group. MBDE will be delivered in 8 weekly group sessions followed by 2 bimonthly individual, booster sessions conducted by phone for a total duration of 6 months. MBDE will be delivered by an interventionist with a background in nursing and training as an MBSR instructor, who will receive additional training in MBDE with an emphasis on content drawn from DSME. Standard DSME will be delivered by a certified diabetes educator in eight weekly sessions of 2 hours duration. Sessions will cover seven core content areas - healthy eating, physical activity, medication usage, self-monitoring, preventing and treating acute and chronic complications, healthy coping, and problem solving.
Total study duration will be six months; a trained study staff will complete assessments of participants in both study arms at baseline, 2 months, and 6 months. Participants in both study arms will complete assessments that will be conducted by trained study personnel, including interviewer-administered questionnaire, biometric assessment (height, weight, blood pressure), and POC A1C testing from a finger-stick sample at 3 time points - baseline, 2 months, and 6 months. Participants in the MBDE arm will be asked to participate in a focus group (estimated length 1 hour) at the 2 month time point. Participants will receive an incentive for their participation for each study assessment and for participation in a focus group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Diabetes Education | Experimental | Behavioral: Mindfulness-Based Diabetes EducationMindfulness-Based Diabetes Education (MBDE) will be delivered in-person in a group of 10-14 participants during 8 weekly sessions followed by 2 bimonthly individual sessions. Sessions integrate Mindfulness-Based Stress Reduction and Diabetes Self-Management Education. MBDE will introduce breath awareness meditation, body scan, walking meditation, mindful yoga, and applying mindfulness to daily activities, as well as core areas from DSME. MBDE will include incremental goal setting to build participants' self-efficacy for diabetes self-management behaviors, mindful attention to diabetes self-management, and on development of social support in the group. Participants will complete daily home mindfulness exercises and self-monitoring of diabetes self-management behaviors. |
| Standard Diabetes Self-Management Education | Active comparator | Behavioral: Standard Diabetes Self-Management Education (DSME)Standard DSME will be delivered in-person, in a group setting with 10-14 participants per group. Standard DSME will be delivered by a certified diabetes educator in eight weekly sessions of 2 hours duration. Sessions will cover seven core content areas - healthy eating, physical activity, medication usage, self-monitoring, preventing and treating acute and chronic complications, healthy coping, and problem solving. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 19-70 years
- Diagnosis of type 2 diabetes (based on the presence of two or more outpatient International Classification of Diseases (ICD-10) codes for type 2 diabetes
- Receipt of care at Cooper Green Mercy Health Systems Authority or Alabama Regional Medical Services (one or more visits to primary care or diabetes clinic within the prior year
- Presence of moderate-severe diabetes distress (score ≥2 on Diabetes Distress Scale
- Suboptimal glycemic control (elevated hemoglobin A1c (A1C) ≥7.5%)
Key exclusion criteria (3 listed)
- Non-English speaking
- Currently pregnant
- Diagnosis of severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis (based on participant self-report)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Diabetes EducationMindfulness-Based Diabetes Education described in study arm. | Behavioural | Mindfulness-Based Diabetes Education |
| Standard Diabetes Self-Management Education (DSME)Standard DSME described in study arm. | Behavioural | Standard Diabetes Self-Management Education |
Primary outcome
Participant assessment of perceived positive and negative effects
Time frame: 2 months
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.
Participant assessment of intervention content
Time frame: 2 months
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.
Participant assessment of appropriateness of intervention duration and frequency
Time frame: 2 months
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.
Participant satisfaction with interventionist
Time frame: 2 months
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.
Participant-reported barriers to engagement with the intervention sessions or content
Time frame: 2 months
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.
Participants' suggestions to improve the intervention
Time frame: 2 months
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants.
Participants' overall satisfaction with the intervention
Time frame: 2 months
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. 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
Time frame: 6 months
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.
Feasibility: percentage of eligible participants who enroll
Time frame: 6 months
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.
Feasibility: ability to randomize participants to study arms
Time frame: 6 months
We will assess the percentage of eligible participants who are randomized. Study staff will track the number of participants who are enrolled and the number of participants who are randomized.
Feasibility: distribution of participants by demographics
Time frame: 6 months
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
Time frame: 6 months
We will track the number of sessions attended by each participant and calculate the percentage of sessions attended by each participant.
Feasibility: participant adherence to study tasks include home mindfulness practices, self-monitoring activities
Time frame: 6 months
At each session, we will collect logs of participants' home mindfulness and self-monitoring activities. We will calculate participant adherence to recommended activities for each participant.
Feasibility: barriers to participation in intervention sessions or completing study activities at home
Time frame: 6 months
We will collect information from participants to assess any barriers they experienced attending study sessions or completing recommended home activities. This information will be obtained during a questionnaire administered to participants in English by a trained interviewer.
Feasibility: reasons for dropping out
Time frame: 6 months
We will collect information from participants who drop out of the intervention or study regarding the reason for dropping out.
Feasibility: overall study retention
Time frame: 6 months
We will track the number of participants who enroll in the study and complete assessments at each time point - baseline, 2 months, and 6 months.
38 secondary outcomes
Hemoglobin A1c
Time frame: Baseline
Hemoglobin A1c
Time frame: 6 months
Diabetes distress
Time frame: Baseline
Diabetes distress
Time frame: 2 months
Diabetes distress
Time frame: 6 months
Diabetes self-management behaviors
Time frame: Baseline
Diabetes self-management behaviors
Time frame: 2 months
Diabetes self-management behaviors
Time frame: 6 months
Medication adherence
Time frame: Baseline
Medication adherence
Time frame: 2 months
Medication adherence
Time frame: 6 months
Mindfulness
Time frame: Baseline
Mindfulness
Time frame: 2 months
Mindfulness
Time frame: 6 months
Emotion regulation
Time frame: Baseline
Emotion regulation
Time frame: 2 months
Emotion regulation
Time frame: 6 months
Self-awareness
Time frame: Baseline
Self-awareness
Time frame: 2 months
Self-awareness
Time frame: 6 months
Self-efficacy as assessed by the Perceived Diabetes Self-Management Scale (PDSMS)
Time frame: Baseline
Self-efficacy as assessed by the Perceived Diabetes Self-Management Scale (PDSMS)
Time frame: 2 months
Self-efficacy as assessed by the Perceived Diabetes Self-Management Scale (PDSMS)
Time frame: 6 months
Social support
Time frame: Baseline
Social support
Time frame: 2 months
Social support
Time frame: 6 months
Perceived stress
Time frame: Baseline
Perceived stress
Time frame: 2 months
Perceived stress
Time frame: 6 months
Depressive symptoms
Time frame: Baseline
Depressive symptoms
Time frame: 2 months
Depressive symptoms
Time frame: 6 months
Anxiety
Time frame: Baseline
Anxiety
Time frame: 2 months
Anxiety
Time frame: 6 months
Type 2 diabetes stigma
Time frame: Baseline
Type 2 diabetes stigma
Time frame: 2 months
Type 2 diabetes stigma
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline A Presley, MD, MPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Diabetes Education and Standard Diabetes Self-Management Education (DSME) in people with Type 2 Diabetes, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant assessment of perceived positive and negative effects (time frame: 2 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.