Mindfulness Training and Group Counseling Among Prediabetes and Diabetes Patients

NCT04702477 | Completed

• 1 other identifier: Pro00076863
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Stress; Mindfulness; Diabetes; Pre-Diabetes

Outcome Measures

Primary Outcomes (1)

• Intervention Attendance

  How many hours of intervention sessions an individual attended

  8-weeks while completing the intervention

Secondary Outcomes (10)

• Perceived Stress Scale

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

• Depression

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

• Anxiety

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

• Medication Adherence

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

• Perceived Health Status

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

Study Arms (1)

Only Arm

EXPERIMENTAL

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

Interventions

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.

Only Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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")

You may not qualify if:

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

Sponsors & Collaborators

• Clemson University: lead
• University of California, Los Angeles: collaborator
• Prisma Health-Upstate: collaborator

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance; Health Behavior

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lu Shi, PhD

  Clemson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

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

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: January 11, 2021
• Study Start: August 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: January 11, 2021

Record last verified: 2020-12

Locations

US (1)