Mindfulness Training and Group Counseling Among Prediabetes and Diabetes Patients

Not Applicable

Completed

• Conditions: Pre-Diabetes; Stress; Quality of Life; Diabetes; Health Behavior
• Interventions: Behavioral: Mindfulness Based Stress Reduction

• Registration Number: NCT04702477
• Lead Sponsor: Clemson University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Study First Submitted: 2020-11-23
• Status Verified: 2020-12
• Study First Submitted QC: 2021-01-07
• Last Update Submitted: 2021-01-07
• Study First Posted: 2021-01-11
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Only Arm	Mindfulness Based Stress Reduction	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

Primary Outcome Measures

Name	Time	Method
Intervention Attendance	8-weeks while completing the intervention	How many hours of intervention sessions an individual attended

Secondary Outcome Measures

Name	Time	Method
Depression	Up to 3 months before intervention, immediately following intervention, one month after intervention	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.
Medication Adherence	Up to 3 months before intervention, immediately following intervention, one month after intervention	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.
Perceived Stress Scale	Up to 3 months before intervention, immediately following intervention, one month after intervention	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.
Perceived Health Status	Up to 3 months before intervention, immediately following intervention, one month after intervention	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.
Physical Activity	Up to 3 months before intervention, immediately following intervention, one month after intervention	Change in physical activity assessed using the Rapid Assessment of Physical Activity Scale (RAPA).
Mindfulness	Up to 3 months before intervention, immediately following intervention, one month after intervention	Change in Mindfulness assessed using a 15-item Five-Facet Mindfulness Questionnaire (FFMQ).
Program satisfaction and barriers for attending sessions	Immediately following intervention	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.
Anxiety	Up to 3 months before intervention, immediately following intervention, one month after intervention	Change in anxiety assessed using the Generalized anxiety disorder 7-item scale (GAD-7).
Sleep Quality	Up to 3 months before intervention, immediately following intervention, one month after intervention	Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) ranges from 7 to 28, with higher scores indicating worse sleep quality.
HbA1C levels	Up to 3 months before intervention, immediately following intervention, one month after intervention	HbA1C blood levels

Trial Locations

Locations (1)

Prisma Health; 🇺🇸 Greenville, South Carolina, United States