Mindfulness Training and Group Counseling Among Prediabetes and Diabetes Patients

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04702477
• Other study ID #: Pro00076863
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: December 2020
• Source: Clemson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Glucose Intolerance
• Health Behavior
• Pre-Diabetes
• Prediabetic State
• Quality of Life
• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Prisma Health	Greenville	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Clemson University	Prisma Health-Upstate, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Attendance	How many hours of intervention sessions an individual attended	8-weeks while completing the intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	HbA1C levels	HbA1C blood levels	Up to 3 months before intervention, immediately following intervention, one month after intervention
Secondary	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