Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress

Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress

Hemoglobin A1c [ Time Frame: Baseline ]
Participants will have a point-of-care A1C measured; A1C will be obtained by trained study personnel using finger-stick testing with the A1C NOW+ 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.

Hemoglobin A1c [ Time Frame: 6 months ]
Participants will have a point-of-care A1C measured; A1C will be obtained by trained study personnel using finger-stick testing with the A1C NOW+ 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.

Diabetes distress [ Time Frame: Baseline ]
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.

Diabetes distress [ Time Frame: 2 months ]
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.

Diabetes distress [ Time Frame: 6 months ]
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.

Diabetes self-management behaviors [ Time Frame: Baseline ]
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.

Diabetes self-management behaviors [ Time Frame: 2 months ]
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.

Diabetes self-management behaviors [ Time Frame: 6 months ]
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.

Medication adherence [ Time Frame: Baseline ]
Participants will complete the Adherence to Refills and Medications-Diabetes (ARMS-D), an 11-item self-report measure that includes medication-taking and refill subscales. Example item is “How often do you forget to take your diabetes medicine(s)?” Participants respond on a 4-point Likert scale from 1 “none of the time” to 4 “all of the time.” Item responses are summed, combining subscales 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.

Medication adherence [ Time Frame: 2 months ]
Participants will complete the Adherence to Refills and Medications-Diabetes (ARMS-D), an 11-item self-report measure that includes medication-taking and refill subscales. Example item is “How often do you forget to take your diabetes medicine(s)?” Participants respond on a 4-point Likert scale from 1 “none of the time” to 4 “all of the time.” Item responses are summed, combining subscales 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.

Medication adherence [ Time Frame: 6 months ]
Participants will complete the Adherence to Refills and Medications-Diabetes (ARMS-D), an 11-item self-report measure that includes medication-taking and refill subscales. Example item is “How often do you forget to take your diabetes medicine(s)?” Participants respond on a 4-point Likert scale from 1 “none of the time” to 4 “all of the time.” Item responses are summed, combining subscales 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.

Mindfulness [ Time Frame: Baseline ]
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.

Mindfulness [ Time Frame: 2 months ]
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.

Mindfulness [ Time Frame: 6 months ]
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.

Emotion regulation [ Time Frame: Baseline ]
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.

Emotion regulation [ Time Frame: 2 months ]
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.

Emotion regulation [ Time Frame: 6 months ]
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.

Self-awareness [ Time Frame: Baseline ]
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.

Self-awareness [ Time Frame: 2 months ]
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.

Self-awareness [ Time Frame: 6 months ]
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.

Self-efficacy as assessed by the Perceived Diabetes Self-Management Scale (PDSMS) [ Time Frame: Baseline ]
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.

Self-efficacy as assessed by the Perceived Diabetes Self-Management Scale (PDSMS) [ Time Frame: 2 months ]
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.

Self-efficacy as assessed by the Perceived Diabetes Self-Management Scale (PDSMS) [ Time Frame: 6 months ]
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.

Social support [ Time Frame: Baseline ]
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.

Social support [ Time Frame: 2 months ]
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.

Social support [ Time Frame: 6 months ]
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.

Perceived stress [ Time Frame: Baseline ]
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.

Perceived stress [ Time Frame: 2 months ]
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.

Perceived stress [ Time Frame: 6 months ]
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.

Depressive symptoms [ Time Frame: Baseline ]
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.

Depressive symptoms [ Time Frame: 2 months ]
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.

Depressive symptoms [ Time Frame: 6 months ]
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.

Anxiety [ Time Frame: Baseline ]
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.

Anxiety [ Time Frame: 2 months ]
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.

Anxiety [ Time Frame: 6 months ]
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.

Type 2 diabetes stigma [ Time Frame: Baseline ]
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.

Type 2 diabetes stigma [ Time Frame: 2 months ]
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.

Type 2 diabetes stigma [ Time Frame: 6 months ]
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.

Source: View full study details on ClinicalTrials.gov

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June 1, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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