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Mindfulness Training and Group Counseling Among Prediabetes and Diabetes Patients

Primary Purpose

Stress, Diabetes, Pre-Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness Based Stress Reduction

About this trial

This is an interventional prevention trial for Stress focused on measuring Stress, Mindfulness, Diabetes, Pre-Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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")

Exclusion Criteria:

Under 18 years old
Non-English Speaking
not having a diagnosis of diabetes or prediabetes
No participation in JUMP model

Sites / Locations

Prisma Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Only Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Intervention Attendance

How many hours of intervention sessions an individual attended

Secondary Outcome Measures

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.

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.

Anxiety

Change in anxiety assessed using the Generalized anxiety disorder 7-item scale (GAD-7).

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.

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.

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.

Physical Activity

Change in physical activity assessed using the Rapid Assessment of Physical Activity Scale (RAPA).

Mindfulness

Change in Mindfulness assessed using a 15-item Five-Facet Mindfulness Questionnaire (FFMQ).

HbA1C levels

HbA1C blood levels

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.

Full Information

NCT ID

NCT04702477

First Posted

November 23, 2020

Last Updated

January 7, 2021

Sponsor

Clemson University

Collaborators

University of California, Los Angeles, Prisma Health-Upstate

1. Study Identification

Unique Protocol Identification Number

NCT04702477

Brief Title

Mindfulness Training and Group Counseling Among Prediabetes and Diabetes Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

January 31, 2020 (Actual)

Study Completion Date

January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Clemson University

Collaborators

University of California, Los Angeles, Prisma Health-Upstate

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Stress, Mindfulness, Diabetes, Pre-Diabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Only Arm

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness Based Stress Reduction

Intervention Description

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.

Primary Outcome Measure Information:

Title

Intervention Attendance

Description

How many hours of intervention sessions an individual attended

Time Frame

8-weeks while completing the intervention

Secondary Outcome Measure Information:

Title

Perceived Stress Scale

Description

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.

Time Frame