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

NCT07793097 | Not Yet Recruiting DMC

• 2 other identifiers: IRB-25-05-7727R01DK141816
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Recruitment Feasibility / Number Screened

  The ability to successfully identify and screen for study eligibility the target number of participants within the planned study timeline.

  From recruitment initiation to recruitment termination / 18 months

• Recruitment Feasibility / Number Enrolled

  The ability to successfully enroll the target number of participants within the planned study timeline.

  From recruitment initiation to recruitment termination / 18 months

• Retention Feasibility / Number Retained

  The ability to successfully retain participants in the study.

  From date of first participant enrollment to date of last participant completion / 18 months

• Intervention Feasibility / Number of MBSR treatment sessions attended

  Participants' willingness and ability to engage with and complete the intervention as designed.

  From date of treatment initiation to date of treatment termination / 9 weeks

• Intervention Fidelity / Concise Fidelity for Mindfulness-Based Interventions (CoFi-MBI)

  The CoFi-MBI assesses three domains of intervention fidelity: content delivery (6 Y/N items), participant engagement (5-point Likert scale, 2 items), and technology challenges (5-point Likert scale, 1 item).Cohort level summary scales are calculated as the percentage of sessions each content element was present with higher scores indicating greater fidelity, the mean level of participant engagement with higher scores indicating greater fidelity, and technology obstacles experienced across sessions with lower scores indicating greater fidelity.

  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)

  Participants' satisfaction with the intervention protocol in 3 domains assessed with 4 items in each domain: acceptability, appropriateness, and feasibility. Scores are computed by taking the mean of the 4 items comprising each scale with higher scores indicating greater satisfaction.

  From date of treatment initiation to date of treatment termination / 9 weeks

• Glycemic control / Hemoglobin A1c (HbA1c)

  Hb1Ac will be obtained by using the Accubase A1c test kit

  Baseline/0 month, Treatment End/3 months

• Glycemic control / Mean blood glucose

  Mean blood glucose will be obtained via 14-day manual download of glucometer data or direct download of continuous glucose monitor (CGM) data

  Baseline/0 month, Treatment End/3 months

Secondary Outcomes (6)

• Psychological distress / Stress Reactivity

  Baseline/0 month, Treatment End/3 months

• Psychological distress / Perceived stress

  Baseline/0 month, Treatment End/3 months

• Psychological distress / Diabetes-specific stress

  Baseline/0 month, Treatment End/3 months

• Psychological distress / Depression

  Baseline/0 month, Treatment End/3 months

• Psychological distress / Anxiety

  Baseline/0 month, Treatment End/3 months

Study Arms (2)

MBSR-VR

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Stress Reduction - Virtual Reality

Treatment as Usual (TAU)

OTHER

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.

Other: Stress tip sheet

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.

Also known as: MBSR-VR

MBSR-VR

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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

Related Links

• NIH RePORTER Listing
• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• April Idalski Carcone, PhD, MSW

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Erica MS Sibinga, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made accessible no later than the time of our associated publication or the end of the grant period (whichever comes first). The data shared will be archived and available on the Vivli platform for request by researchers for a minimum of 10 years after contribution.
• Access Criteria: Datasets resulting from this study will be shared in Vivli, a sustainable platform providing metadata indexed via Datacite and DOIs for all objects. All data will be shared publicly under a data use agreement (DUA) through a managed access process. Long-term access is freely provided to researchers. Vivli provides searchable study-level metadata for dataset discovery. Vivli assigns DOIs and ORCID IDs as persistent identifiers, and long-term access. Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform. Datasets stored by Vivli are available after the execution of a data use agreement.

Locations

US (2)