Trial Outcomes & Findings for Intervention Mapping to Adapt a Mindfulness-based Intervention for Adults With Diabetes and Emotional Distress (NCT NCT03987841)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Baseline

Results posted on

2023-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Integrated MBSR/DSME Intervention n=5 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 6.78 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Integrated MBSR/DSME Intervention n=5 Participants 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.
Diabetes Distress	2.64 score on a scale Standard Deviation 0.94

PRIMARY outcome

Timeframe: 2-months

Measured by the diabetes distress scale (DDS), a 17-item self-report measure, assessing domains of emotional burden, physician-related distress, regimen-related distress, and interpersonal distress. The questionnaire will be administered to participants in English by a trained interviewer. The mean item score yields a possible score from 1 to 6; a score of \<2 indicates little/no distress, 2 to 2.9 moderate distress, and ≥3 high distress.

Outcome measures

Outcome measures
Measure	Integrated MBSR/DSME Intervention n=5 Participants 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.
Diabetes Distress	2.19 score on a scale Standard Deviation 0.68

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Integrated MBSR/DSME Intervention n=5 Participants 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.
Hemoglobin A1c (A1C)	7.14 percentage of glycosylated hemoglobin Standard Deviation 0.88

PRIMARY outcome

Timeframe: 2-months

Participants will have a point-of-care A1C measured; A1C will be obtained by trained study personnel using finger-stick testing with the A1C Now+20 Test Kit (PTS diagnostics). 1C reports a % glycated hemoglobin level; a higher score indicates higher average blood glucose levels over the preceding 3 months. An A1C greater than or equal to 7.5% indicates poorly controlled type 2 diabetes.

Outcome measures

Outcome measures
Measure	Integrated MBSR/DSME Intervention n=5 Participants 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.
Hemoglobin A1c (A1C)	7.24 percentage of glycosylated hemoglobin Standard Deviation 0.98

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Integrated MBSR/DSME Intervention n=5 Participants 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.
Diabetes Self-management Behaviors Diet	3.96 units on a scale Standard Deviation 1.54
Diabetes Self-management Behaviors Exercise	3.4 units on a scale Standard Deviation 2.36
Diabetes Self-management Behaviors Blood Glucose	3.8 units on a scale Standard Deviation 2.41
Diabetes Self-management Behaviors Foot Care	6.3 units on a scale Standard Deviation 1.57

SECONDARY outcome

Timeframe: 2-months

Measured by the Summary of Diabetes Self-Care Activities (SDSCA), a 10-item self-report measure that assesses diet (4-items), exercise (2-items), blood-glucose testing (2-items), and foot care (2-items). An example item is "How many of the last seven days have you followed a healthful eating plan?" Participants respond based on their self-care experience for the preceding week, from 0 to 7 indicating the number of days the participant performed the behavior. Each subscale is scored separately and scores are not combined. For each subscale, the score is the mean item score (i.e. mean number of days the activity was performed, range 0-7). A higher score indicates higher adherence to the self-care behavior. The questionnaire will be administered to participants in English by a trained interviewer.

Outcome measures

Outcome measures
Measure	Integrated MBSR/DSME Intervention n=5 Participants 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.
Diabetes Self-management Behaviors Diet	4.4 units on a scale Standard Deviation 1.47
Diabetes Self-management Behaviors Exercise	3.1 units on a scale Standard Deviation 1.82
Diabetes Self-management Behaviors Blood Glucose	4.7 units on a scale Standard Deviation 2.20
Diabetes Self-management Behaviors Foot Care	5.4 units on a scale Standard Deviation 2.50

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Integrated MBSR/DSME Intervention n=5 Participants 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.
Medication Adherence	17 score on a scale Standard Deviation 9.54

SECONDARY outcome

Timeframe: 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, 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.

Outcome measures

Outcome measures
Measure	Integrated MBSR/DSME Intervention n=5 Participants 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.
Medication Adherence	16.2 score on a scale Standard Deviation 5.17

SECONDARY outcome

Timeframe: 2-months

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

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.

Outcome measures

Outcome measures
Measure	Integrated MBSR/DSME Intervention n=5 Participants 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.
Acceptability of the Intervention to Participants: Semi-structured Interviews Handouts and study materials were easy to understand and useful for participants	5 Participants
Acceptability of the Intervention to Participants: Semi-structured Interviews Participants made changes related to mindful eating, physical activity, and managing stress	5 Participants
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
Acceptability of the Intervention to Participants: Semi-structured Interviews Participant suggestion: more clearly linking discussions about stress and diabetes management	5 Participants
Acceptability of the Intervention to Participants: Semi-structured Interviews Participant suggestion: include more examples and opportunities to practice exercises	5 Participants
Acceptability of the Intervention to Participants: Semi-structured Interviews Participant suggestion: include multiple methods to access guidance for home practices	5 Participants
Acceptability of the Intervention to Participants: Semi-structured Interviews Overall satisfaction with program was high	5 Participants

SECONDARY outcome

Timeframe: Baseline

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

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.

Outcome measures

Outcome measures
Measure	Integrated MBSR/DSME Intervention n=16 Participants 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.
Feasibility: Percentage of Screened Participants Who Are Eligible	11 Participants

SECONDARY outcome

Timeframe: Baseline

Population: This is the number of eligible participants.

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.

Outcome measures

Outcome measures
Measure	Integrated MBSR/DSME Intervention n=11 Participants 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.
Feasibility: Percentage of Eligible Participants Who Enroll	5 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Integrated MBSR/DSME Intervention n=5 Participants 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.
Feasibility: Distribution of Participants by Demographics Non-Hispanic white male	1 Participants
Feasibility: Distribution of Participants by Demographics Non-Hispanic Black female	3 Participants
Feasibility: Distribution of Participants by Demographics Non-Hispanic Black male	1 Participants

SECONDARY outcome

Timeframe: 2-months

We will track the number of sessions attended by each participant and calculate the percentage of overall sessions attended for each participant.

Outcome measures

Outcome measures
Measure	Integrated MBSR/DSME Intervention n=5 Participants 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.
Feasibility: Percentage of Sessions Attended 100% attendance	3 Participants
Feasibility: Percentage of Sessions Attended 85% attendance	1 Participants
Feasibility: Percentage of Sessions Attended 71% attendance	1 Participants

Adverse Events

Integrated MBSR/DSME Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Caroline Presley

University of Alabama at Birmingham

Phone: 205-934-7609

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place