Mindfulness Training and Group Counseling Among Prediabetes and Diabetes Patients

Sponsor

Clemson University (Other)

Overall Status

Completed

CT.gov ID

NCT04702477

Collaborator

University of California, Los Angeles (Other), Prisma Health-Upstate (Other)

Enrollment

Location

Arm

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stress Diabetes Pre-Diabetes Health Behavior Quality of Life	Behavioral: Mindfulness Based Stress Reduction	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a single-arm, paired-sample pilot intervention study.This is a single-arm, paired-sample pilot intervention study.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 1, 2018

Actual Primary Completion Date :

Jan 31, 2020

Actual Study Completion Date :

Jan 31, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Intervention Attendance [8-weeks while completing the intervention]
How many hours of intervention sessions an individual attended

Secondary Outcome Measures

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.
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.
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).
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 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.
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.
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).
HbA1C levels [Up to 3 months before intervention, immediately following intervention, one month after intervention]
HbA1C blood levels
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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")