Mindfulness and Virtual Reality for Type 1 Diabetes

(MBSR-VR Trial)

Not yet recruiting at 1 trial location
SC
Overseen ByStudy Coordinator
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Wayne State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to learn if Mindfulness-Based Stress Reduction (MBSR) can be delivered using virtual reality (VR) technology to emerging adults (youth 16-20 years old) with type 1 diabetes and high levels of stress reactivity. If successful, MBSR-VR has the potential to reach many people who may be living in different places who might not have access to programs like MBSR. This is important because young adults with a chronic illness like diabetes and high levels of stress have been shown to have worse health than young adults with lower stress and young adults without diabetes. This study has not been designed to determine if MBSR-VR improves the health of young adults with diabetes (improves their glycemic control),their feelings of distress (this includes stress, depression, and anxiety), or their mindfulness (being more aware of their thoughts, feelings, actions, and environment) but we will look to see if people are reporting improvements in these areas.

Who Is on the Research Team?

AI

April Idalski Carcone, PhD, MSW

Principal Investigator

Wayne State University

EM

Erica MS Sibinga, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for young adults aged 16-20 who have type 1 diabetes and experience high stress. Participants should not have conditions that would prevent them from using virtual reality or participating in mindfulness activities.

Inclusion Criteria

Have elevated levels of stress reactivity as assessed by the Perceived Stress Reactivity Scale (PSRS)
I have had type 1 diabetes for at least six months.
Access to an internet-enabled device on which the participant can participate in virtual study activities
See 1 more

Exclusion Criteria

I do not have severe mental health issues that prevent me from joining group activities.
Co-morbid physical health problems in which diabetes is secondary to another chronic medical illness (e.g., cystic fibrosis) and their medical management differs substantially from that of most youth with T1D
Non-English fluency

What Are the Treatments Tested in This Trial?

Interventions

  • Mindfulness-Based Stress Reduction - Virtual Reality

Trial Overview

The study compares a Mindfulness-Based Stress Reduction program delivered through virtual reality to receiving a simple stress tip sheet, aiming to see if VR mindfulness can help reduce stress in young people with type 1 diabetes.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Treatment as Usual (TAU)Experimental Treatment1 Intervention
Group II: MBSR-VRExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials
318
Recruited
111,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+