Recruiting

MBSR-VR

Sponsor:

Wayne State University

Code:

NCT07793097

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 16 - 20

Healthy Volunteers: Not accepted

Interventions

Mindfulness-Based Stress Reduction - Virtual Reality

Stress tip sheet

Study Details

Brief summary:

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.

Conditions

Type 1 Diabetes

Study ID

NCT07793097

Start date

Nov 3, 2026

Status verified date

Nov, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 20

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 16 to 20 years, inclusive
  • Diagnosed with type 1 diabetes (T1D) for at least six months
  • Have elevated levels of stress reactivity as assessed by the Perceived Stress Reactivity Scale (PSRS)
  • Access to an internet-enabled device on which the participant can participate in virtual study activities

Exclusion Criteria:

  • Significant co-morbid mental health problems limiting the participant's ability to engage effectively in the group nature of the intervention (i.e., thought disorders like schizophrenia, severe cognitive impairment, suicidality or homicidality)
  • 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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Mindfulness-Based Stress Reduction - Virtual Reality

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

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.

Primary outcome measure

  • Recruitment Feasibility / Number Screened [ Time Frame: From recruitment initiation to recruitment termination / 18 months ]
  • Recruitment Feasibility / Number Enrolled [ Time Frame: From recruitment initiation to recruitment termination / 18 months ]
  • Retention Feasibility / Number Retained [ Time Frame: From date of first participant enrollment to date of last participant completion / 18 months ]
  • Intervention Feasibility / Number of MBSR treatment sessions attended [ Time Frame: From date of treatment initiation to date of treatment termination / 9 weeks ]
  • Intervention Fidelity / Concise Fidelity for Mindfulness-Based Interventions (CoFi-MBI) [ Time Frame: From date of treatment initiation to date of treatment termination / 9 weeks ]
  • Intervention Acceptability / 18) Acceptability of Intervention Measure (AIM) | Intervention Appropriateness Measure (IAM) | Feasibility of Intervention Measure (FIM) [ Time Frame: From date of treatment initiation to date of treatment termination / 9 weeks ]
  • Glycemic control / Hemoglobin A1c (HbA1c) [ Time Frame: Baseline/0 month, Treatment End/3 months ]
  • Glycemic control / Mean blood glucose [ Time Frame: Baseline/0 month, Treatment End/3 months ]

Central Contacts and Locations

Central contacts

Study Coordinator

1-313-577-6997MBSR-VR@wayne.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Study Coordinator

1-410-502-8700ykim227@jhu.edu

Principal Investigator:

Erica MS Sibinga, MD

Wayne State University

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Study Coordinator

1-313-577-6997MBSR-VR@wayne.edu

Principal Investigator:

April Idalski Carcone, PhD, MSW

More Information

Sponsor

Wayne State University

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

  • mindfulness
  • emerging adults
  • stress
  • diabetes
  • MBSR
  • virtual reality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Wayne State University on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.