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?

This trial tests whether mindfulness techniques, delivered through virtual reality, can help young adults with type 1 diabetes manage stress more effectively. The researchers aim to determine if this method can make mindfulness programs more accessible to those who might not otherwise have access. Participants will either engage in a 9-week virtual mindfulness program (Mindfulness-Based Stress Reduction - Virtual Reality) or continue with their usual stress management methods. The trial seeks participants aged 16 to 20 who have had type 1 diabetes for at least six months and experience high stress levels. As an unphased trial, it offers a unique opportunity to explore innovative stress management techniques in a supportive environment.

What prior data suggests that Mindfulness-Based Stress Reduction - Virtual Reality is safe for emerging adults with type 1 diabetes?

Research has shown that Mindfulness-Based Stress Reduction (MBSR) through virtual reality (VR) is generally easy for people to handle. Studies have found that participants engage more and are less likely to drop out of VR mindfulness programs compared to traditional ones, indicating that VR-based mindfulness is easier to maintain.

In a study with teens who have diabetes, most completed the MBSR program, demonstrating its manageability. Another study showed that MBSR can reduce emotional distress in people with diabetes, suggesting participants found it helpful without major issues.

Overall, these findings suggest that the MBSR-VR treatment is safe. Participants typically complete the programs and experience positive results without significant problems.12345

Why are researchers excited about this trial?

Researchers are excited about using Mindfulness-Based Stress Reduction enhanced with Virtual Reality (MBSR-VR) for managing Type 1 Diabetes because it offers a fresh approach to stress management, a key factor in diabetes control. Unlike traditional methods like insulin therapy and blood glucose monitoring, which directly manage blood sugar levels, MBSR-VR focuses on reducing stress through mindfulness practices delivered via virtual reality. This innovative delivery method makes mindfulness more engaging and accessible, potentially enhancing adherence and effectiveness. By integrating technology with mindfulness, MBSR-VR may help improve overall well-being, making it an intriguing addition to traditional diabetes management strategies.

What evidence suggests that Mindfulness-Based Stress Reduction - Virtual Reality is effective for stress in young adults with type 1 diabetes?

Research has shown that Mindfulness-Based Stress Reduction (MBSR) can reduce stress, depression, and anxiety. Studies have found that MBSR increases awareness of thoughts and feelings, leading to improved stress management. In this trial, participants in the MBSR-VR arm will undergo a 9-week virtually delivered MBSR program enhanced with virtual reality, potentially making the process more engaging and accessible for young adults. Managing stress is crucial for individuals with type 1 diabetes, as high stress can affect health. Although specific data on using MBSR with VR for diabetes is not yet available, combining mindfulness with VR appears promising for helping young adults manage stress more effectively.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (virtual)

Treatment

Participants receive a 9-week virtually delivered Mindfulness-Based Stress Reduction program enhanced with virtual reality

9 weeks
Weekly sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (virtual)

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+

Citations

The Effectiveness of Virtual Reality–Based Mindfulness

Meta-analyses demonstrate that VR interventions achieve higher engagement rates and lower dropout compared to traditional delivery methods;

Virtual Reality Archives | CCH

The study, titled “Feasibility of MBSR-VR to Reduce Stress among Emerging Adults with T1D,” is supported by a three-year grant of $941,418 from ...

Mindfulness Based Stress Reduction Groups- Satisfaction Study

This study investigates mindfulness-based stress reduction for teens with diabetes and their caregivers.

Mindfulness-based stress reduction is associated with ...

Eleven of 14 patients completed the intervention. At 1 month follow-up, HA1c was reduced by 0.48% (P=.03), and mean arterial pressure was reduced by 6 mmHg (P= ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28781569/

effect on emotional distress in diabetes - PubMed - NIH

It was concluded that MBSR training is a promising, group-based intervention that can be used to decrease psychological distress in individuals with diabetes ...