Can Mindfulness and Virtual Reality Reduce Stress in Young Adults With Type 1 Diabetes?

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Wayne State University
Study ID
NCT07793097
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • Mindfulness-Based Stress Reduction - Virtual Reality — BEHAVIORAL
    Participants will receive group-delivered MBSR adapted for emerging adults with type 1 diabetes and virtual delivery including virtual reality technology. The intervention consists of instruction and practice in meditation, use of mindfulness techniques, the mind-body connection, and group discussions focused on mindfulness practice. MBSR intervention content includes 1) practicing a variety of mindfulness meditations, including sitting meditation, walking meditation, body scan, and mindful movement/gentle yoga; 2) learning to pay attention to, observe and describe moment-to moment experience in a way that promotes acceptance; 3) understanding stress reactions (stress symptoms, causes, effects) and how to create a mindful response to stressful situations; and 4) facilitators and barriers to applying mindfulness to everyday activities including eating, listening, communicating, walking and other activities.
  • Stress tip sheet — OTHER
    Participants will receive an educational stress management tip sheet developed by the American Diabetes Association. The resource provides information about the relationship between stress and diabetes, strategies for recognizing signs of stress, and practical techniques for coping with stress, including relaxation, physical activity, social support, and healthy self-care behaviors.

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
Feb 28, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MBSR-VR
    Participants will receive a 9-week virtually delivered Mindfulness-Based Stress Reduction program enhanced with virtual reality (MBSR-VR). The intervention includes instructor-led mindfulness training, guided meditation practices, and home-based mindfulness exercises delivered remotely using video conferencing and virtual reality technology. Participants will be asked to complete weekly sessions and engage in regular mindfulness practice throughout the intervention period.
  • Other: Treatment as Usual (TAU)
    Emerging adults assigned to TAU will be offered a stress management tip sheet and will otherwise continue to manage their stress using their usual manner. No other treatment services will be offered and they will not be prevented from seeking alternative treatment independent of the research study.

Primary Outcome Measure

Recruitment Feasibility / Number Screened [ Time Frame: From recruitment initiation to recruitment termination / 18 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21218
Study Coordinator
1-410-502-8700
Erica MS Sibinga, MD (PRINCIPAL_INVESTIGATOR)
Wayne State UniversityDetroitMichigan48202
Study Coordinator
1-313-577-6997
April Idalski Carcone, PhD, MSW (PRINCIPAL_INVESTIGATOR)

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