Clinical trial to study if mindfulness helps with diabetes-related stress, health
College of Medicine-led mindfulness-based stress reduction clinical trial open to participants across U.S.
Everyone experiences some degree of stress, but evidence shows chronic stress from living with diabetes may affect patients’ health. Researchers at Penn State College of Medicine are seeking volunteers from across the U.S. to participate in a clinical trial examining whether online mindfulness-based stress reduction can reduce stress and average blood sugar levels in those with Type 1 or Type 2 diabetes — an estimated 463 million people worldwide.
Mindfulness is a state of self-awareness in the present moment while simultaneously acknowledging and accepting one’s feelings, thoughts and body sensations without judging them as good or bad. As early as 1979, Western medicine programs used mindfulness as a technique for reducing and managing stress. According to the research team, learning to live with and manage a diabetes diagnosis can cause stress for patients.
“Proper management of diabetes requires careful planning, monitoring and adherence to medication, diet and exercise regimens,” said Dr. Nazia Raja-Khan, associate professor of medicine, obstetrics and gynecology and psychiatry and behavioral health. “These requirements can be taxing for people, and as prior studies have indicated, can negatively affect their ability to successfully manage their condition.”
Researchers will compare two online programs that target stress in people with diabetes and determine whether they can help patients better manage their health. One group will participate in a six-month online mindfulness-based stress reduction (MBSR) program consisting of an initial eight-week course on standard mindfulness techniques followed by monthly “mindfulness boosters” for four months. The control group will receive a similarly structured regular stress management education program in nutrition, exercise and other diabetes-related health topics. The study team will not know which group patients are assigned to.
At the beginning and end of the six month period, researchers will measure hemoglobin A1C — a test that determines average blood sugar over a three-month period — and perceived stress levels and compare them to evaluate the success of each program. The fully remote trial is open to patients 18 years and older with Type 1 or Type 2 diabetes in the U.S. Participation is voluntary and compensation is provided.
“Our hope is that mindfulness-based stress reduction can empower people living with diabetes,” said Raja-Khan, principal investigator of the study. “Through the course they’ll learn skills like self-regulation, adaptive coping mechanisms and methods for reducing stress that may lead to improved health outcomes.”
For more information on this study, visit ClinicalTrials.gov and search identifier NCT04016415.
Larisa Zifchak, Avery Briguglio, Sundal Ghori, Christina Ward, Nicole Briley, Liza Rovniak, Dahlia Mukherjee, Allen Kunselman, Emily Wasserman and Sara Marlin of Penn State College of Medicine; Donald McCown of West Chester University of Pennsylvania; and Holly Socolow are also contributing to this project. The researchers declare no conflicts of interest.
This research is supported by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health (NIH) (grant number R01 DK-119379-03). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
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