By Gerol Fang
This clinical trial is currently recruiting – participants will be enrolled in one of two stress-intervention courses to measures changes in A1C, diabetes distress, and more.
Clinical Trials Identifier: NCT04016415
Trial name: Decreasing Stress in Diabetes (De-Stress)
Diabetes type: Type 1 and Type 2
What is the trial testing?
This trial will compare the effects of two virtual behavioral intervention programs that target stress in people with diabetes to evaluate the impact of mindfulness practices on diabetes management.
The randomized controlled trial will test the six-month online Mindfulness-Based Stress Reduction (MBSR) program against Stress Management Education (SME), as a control. Participants randomly assigned to the MBSR group will follow an eight-week curriculum based on standardized mindfulness techniques, followed by monthly “mindfulness boosters” over the next four months. Those participating in SME will follow a similar protocol, receiving education in nutrition, exercise, and other diabetes-relevant health topics. While the SME program is designed to mirror the MBSR structure, it specifically does not include mindfulness activities.
What is the trial measuring?
The researchers will look at several outcomes among participants at two-month and six-month checkpoints:
Changes in A1C from baseline
Changes in Diabetes Distress Scale (DDS) outcomes from baseline
Changes in Perceived Stress Scale-10 (PSS-10) outcomes from the baseline
To understand how the two intervention programs distinctly impact psychosocial and behavioral mechanisms, this trial will also monitor diabetes-related distress, dietary intake, physical activity, and more.
Why is this important?
While there is discussion around diabetes-induced stress, this trial looks at the inverse – how stress levels can impact an individual’s diabetes management (as measured by changes in a person’s A1C).
The MBSR curriculum was developed for patient intervention and is a thoroughly researched, standardized mindfulness program for people with psychological distress. The hope is that MBSR may be found to empower people with diabetes with skills such as self-regulation, adaptive coping mechanisms, and reducing stress reactivity. This, in turn, could strengthen diabetes management.
In addition, the virtual format of these interventions is significant during the COVID-19 pandemic. The investigators are interested to see if mindfulness activities taught over videoconferencing platforms can meaningfully impact people with diabetes.
Trial length: 6 months
Trial location: Good news – this trial is fully remote!
Are you interested?
The trial is recruiting now. You may be eligible to join the study if you:
Are 18 years or older
Have been diagnosed with type 1 or type 2 diabetes for at least one year
Have an A1C greater than or equal to 8% within eight weeks before the study orientation session
Have a device with a camera and microphone and are willing to participate in a live, interactive, virtual classroom
Have a primary care provider