Decreasing Stress in Diabetes

Summary

The purpose of this study is to conduct a randomized controlled trial (RCT) to determine the effects of an online 6-month Mindfulness-based stress reduction (MBSR) intervention compared to an active control Stress Management Education (SME) on glucose control in adults with uncontrolled type 1 or type 2 diabetes. The study will randomize at least 290 adults with uncontrolled diabetes to a 6-month MBSR intervention or SME control. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing. Outcomes will be assessed at baseline, a follow-up phone call after Class #4, and study visits at 2-months (2MO) and 6-months (6MO).

Conditions

• Stress
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type 1

Interventions

BEHAVIORAL

Mindfulness Based Stress Reduction

Subjects randomized to Mindfulness-Based Stress Reduction (MBSR) will receive the 8-week University of Massachusetts Authorized MBSR curriculum followed by monthly mindfulness boosters in Months 3 to 6. The University of Massachusetts MBSR curriculum was selected for the intervention, as it is the most standardized and researched mindfulness program that has been shown to reduce psychological distress in various patient populations.

BEHAVIORAL

Stress Management Education

Subjects randomized to Stress Management Education (SME) will receive health education on nutrition (adapted for the type 2 diabetes population), exercise as gentle stretching to match yoga in MBSR, and other general health topics that may be relevant to the type 2 diabetes population such as sleep, time management, etc. Stress Management Education does not have any mindfulness in it. Stress Management Education was specifically created as a control condition for MBSR studies so it matches MBSR for time, social support, homework, etc.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Rowan University

  collaborator OTHER

• West Chester University of Pennsylvania

  collaborator OTHER

• Georgetown University

  collaborator OTHER

• Milton S. Hershey Medical Center

  lead OTHER

Principal Investigators

• Nazia T Raja-Khan, M.D., M.S. · Milton S. Hershey Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-28

Primary Completion

2024-08-09

Completion

2024-08-09

Countries

• United States

Study Locations