Skip to main content
OpenTrials
Completed

NCT Number: NCT04702477

Mindfulness Training and Group Counseling Among Prediabetes and Diabetes Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prisma Health

Greenville, South Carolina, 29605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Based Stress Reduction

Behavioral

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 outcomes

  1. Intervention Attendance

    Time frame: 8-weeks while completing the intervention

    How many hours of intervention sessions an individual attended

Secondary outcomes

  1. Perceived Stress Scale

    Time frame: 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.

  2. Depression

    Time frame: 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.

  3. Anxiety

    Time frame: 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).

  4. Medication Adherence

    Time frame: 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.

  5. Perceived Health Status

    Time frame: 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.

  6. Sleep Quality

    Time frame: 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.

  7. Physical Activity

    Time frame: 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).

  8. Mindfulness

    Time frame: 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).

  9. HbA1C levels

    Time frame: Up to 3 months before intervention, immediately following intervention, one month after intervention

    HbA1C blood levels

  10. Program satisfaction and barriers for attending sessions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Clemson University

Other

Collaborators

  • Prisma Health-Upstate
  • University of California, Los Angeles

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 11, 2021
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.