Mindfulness Training and Group Counseling Among Prediabetes and Diabetes Patients

Study Overview
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Brief Summary
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Examining a number of health outcomes in those with diabetes and prediabetes before and after a group-based mindfulness intervention.

Detailed Description
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This is a pilot study to examine the feasibility of integrating a mindfulness-based stress reduction (MBSR) intervention in addition to an existing group-based, peer supported clinical care model (JUMP) among patients with pre-diabetes or diabetes using a mixed-method design.

Official Title
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An Innovative Approach With Group Counseling and Mindfulness Training Among Prediabetes Patients

Conditions
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Stress, Diabetes, Pre-Diabetes, Health Behavior, Quality of Life

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress Reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older English speaking Having a diagnosis of diabetes or prediabetes Participation in a previous group-based clinical care model-JUMP (as in JUMPing into Diabetes Control) Exclusion Criteria: Under 18 years old Non-English Speaking not having a diagnosis of diabetes or prediabetes No participation in JUMP model

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single-arm, paired-sample pilot intervention study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Only Arm<br>This is a single-arm, paired-sample pilot intervention study among participants with pre-diabetes or diabetes. Goal to integrate a MBSR intervention into a group-based, lifestyle intervention among patients with prediabetes or diabetes in the primary care setting | Behavioral: Mindfulness Based Stress Reduction<br>* Mindfulness Based Stress Reduction (MBSR) is a well-documented approach to reduce participants' stress level [19], with the existing group-based peer support, self-empowerment, and lifestyle counseling intervention. MBSR is a type of meditation therapy with the goal of actively cultivating conscious attention and awareness to enhance health benefits. This included 10 hours of intervention with groups of 3-5 people.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Attendance | How many hours of intervention sessions an individual attended | 8-weeks while completing the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale | Change in perceived stress measured by 4 Items to assess perceived stress where higher levels indicating higher levels of stress with a range of 4 to 20. | Up to 3 months before intervention, immediately following intervention, one month after intervention | 
| Depression | Change in depression scores from the Center for Epidemiologic Studies Depression Scale (CES-D), where higher scores indicate higher levels of depression with a range of 0 to 80. | Up to 3 months before intervention, immediately following intervention, one month after intervention | 
| Anxiety | Change in anxiety assessed using the Generalized anxiety disorder 7-item scale (GAD-7). | Up to 3 months before intervention, immediately following intervention, one month after intervention | 
| Medication Adherence | Change in medication adherence assessed using the 8-item Morisky Medication Adherence Scale. A higher score indicates higher adherence with a range of 0 to 8. | Up to 3 months before intervention, immediately following intervention, one month after intervention | 
| Perceived Health Status | Change in perceived health status assessed using a question asking participants to rate their health status on a 5-points rating scale where lower ratings indicate higher levels of perceived health status and higher ratings indicate lower levels of perceived health status. | Up to 3 months before intervention, immediately following intervention, one month after intervention | 
| Sleep Quality | Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) ranges from 7 to 28, with higher scores indicating worse sleep quality. | Up to 3 months before intervention, immediately following intervention, one month after intervention | 
| Physical Activity | Change in physical activity assessed using the Rapid Assessment of Physical Activity Scale (RAPA). | Up to 3 months before intervention, immediately following intervention, one month after intervention | 
| Mindfulness | Change in Mindfulness assessed using a 15-item Five-Facet Mindfulness Questionnaire (FFMQ). | Up to 3 months before intervention, immediately following intervention, one month after intervention | 
| HbA1C levels | HbA1C blood levels | Up to 3 months before intervention, immediately following intervention, one month after intervention | 
| Program satisfaction and barriers for attending sessions | Open ended questions to address engagement in the intervention, perceived usefulness of the MBSR, recommendations for intervention modification, what participants enjoyed most/least about the intervention, and reasons for missing intervention sessions. This is a qualitative measure, not numeric values were assigned. Based on Zgierska A, Rabago D, Zuelsdorff M, Coe C, Miller M, Fleming M. Mindfulness meditation for alcohol relapse prevention: a feasibility pilot study. J Addict Med. 2008 Sep;2(3):165-73. doi: 10.1097/ADM.0b013e31816f8546. | Immediately following intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Mindfulness, Diabetes, Pre-Diabetes