Mindfulness Training and Group Counseling Among Prediabetes and Diabetes Patients

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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Diabetes; Stress; Health Behavior; Pre-Diabetes
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Only Arm; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clemson University
• Collaborators: University of California, Los Angeles; Prisma Health-Upstate

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): January 31, 2020
• Study Completion (ACTUAL): January 31, 2020

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (ACTUAL): January 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes; Stress; Mindfulness; Pre-Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: Pro00076863

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No