Type 1 DiabetesMBSR-VRNCT07793097
Can Mindfulness and Virtual Reality Reduce Stress in Young Adults With Type 1 Diabetes?
A study testing Mindfulness-Based Stress Reduction - Virtual Reality and Stress tip sheet in people with Type 1 Diabetes, run by Wayne State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 20 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Mindfulness-Based Stress Reduction - Virtual Reality and Stress tip sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21218
Study Coordinator, 1-410-502-8700, ykim227@jhu.edu
Erica MS Sibinga, MD
Wayne State University
Detroit, Michigan, 48202
Study Coordinator, 1-313-577-6997, MBSR-VR@wayne.edu
april.idalski@gmail.com
About this study
Official title: Feasibility of MBSR-VR to Reduce Stress Among Emerging Adults With T1D
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.
Read the detailed description
The goal of this research is to assess the feasibility of a highly scalable intervention, Mind-fulness-Based Stress Reduction (MBSR) delivered virtually enhanced with virtual reality (VR), for improving health outcomes through the reduction of stress in a high-risk population, emerging adults (EAs; 16-20 years) with high levels of stress reactivity. The primary aim of this project is to adapt MBSR for virtual delivery enhanced with VR in collaboration with a Youth Community Advisory Board (YCAB, composed of five EAs with T1D) and to assess feasibility and the acceptability of MBSR-VR for EAs with T1D and elevated levels of stress reactivity. This feasibility study will use a multi-center randomized controlled pilot study design with 48 EAs with T1D and elevated stress (as as-sessed with the Perceived Stress Reactivity Scale). EAs will be randomized in a 1:1 ratio to MBSR-VR or treat-ment as usual (TAU, standard care control). Three cohorts of 16 participants, 48 total, will be enrolled through two clinical research centers (CRCs) at Wayne State University (WSU) in Detroit, Michigan and Johns Hopkins University (JHU) in Baltimore, Maryland. The WSU site will recruit via the T1D Exchange (T1DX) and JHU via their affiliate diabetes clinics. Participants will enter the study during an 8-week period during which research staff will obtain informed consent and assess eligibility via a stress screener; eligible participants will continue with their baseline data collection (T1). Once 16 participants have enrolled, they will be randomized in a single block, 8 to MBSR and 8 to TAU, and those assigned to MBSR will be oriented to the VR technology. All partici-pants will continue to receive standard medical care from their usual diabetes care provider. Treatment groups will run for 9 weeks followed by a 4-week post-treatment data collection (T2) period. The YCAB will assist with monitoring study progress and refining study procedures (e.g., recruitment strategies) over the course of the trial. Feasibility and acceptability will be established through achieving recruitment, retention and intervention bench-marks. Recruitment feasibility will be established by accruing 8 participants every 4 weeks (16 over 8 weeks) and fewer than 15% excluded due to lack of access to an internet-enabled device. Retention feasibility will be established with 85% retention at the end of treatment data collection and <15% of dropouts due to technology challenges that impeded study participation. Intervention feasibility will be established if EAs attend ≥5 of 9 MSBR intervention sessions, ≥90% of the intervention content is delivered, staff collect >75% of self-practice diaries, MBSR fidelity ratings are ≥4 out of 5 on average, and EAs express satisfaction via qualitative interviews and quantitative assessment (≥3 out of 4).
- Conditions
- Type 1 Diabetes
- Being tested
- Mindfulness-Based Stress Reduction - Virtual Reality, Stress tip sheet
- Keywords
- mindfulness, emerging adults, stress, diabetes, MBSR, virtual reality
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction - Virtual RealityBehavioural
Also called MBSR-VR
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 sheetOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Stress tip sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility / Number Screened
The ability to successfully identify and screen for study eligibility the target number of participants within the planned study timeline.
Measured: 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.
Measured: From recruitment initiation to recruitment termination / 18 months
Retention Feasibility / Number Retained
The ability to successfully retain participants in the study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline/0 month, Treatment End/3 months
Secondary outcomes (6)
Psychological distress / Stress Reactivity
Stress Reactivity will be assessed using the 23-item Perceived Stress Reactivity Scale (PSRS), a psychometrically valid, self-report measure assessing individuals' perceived reactivity to work overload, social evaluation, social conflicts, failure, and prolonged reactivity. A mean PSRS scores >18 in males and >23 in females is the cut point defining "high stress reactivity".
Measured: Baseline/0 month, Treatment End/3 months
Psychological distress / Perceived stress
General psychological stress will be measured with the 10-item Perceived Stress Scale (PSS), a self-report questionnaire assessing perceptions of stress.
Measured: Baseline/0 month, Treatment End/3 months
Psychological distress / Diabetes-specific stress
Diabetes-specific stress will be measured using the 20-item Problem Areas in Diabetes (PAID) scale, a self-report questionnaire assessing diabetes-specific emotional distress. Participants use a 5-point Likert scale ranging from 0 = "no problem" to 4 = "a serious problem" to rate their distress. Items are summed and multiplied by 1.25 to generate a score of 0-100 with higher scores indicating greater emotional distress.
Measured: Baseline/0 month, Treatment End/3 months
Psychological distress / Depression
Symptoms of depression will be assessed with 8-item Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Short-Version Depression Scale, a self-report measure assessing negative mood (e.g., sadness, unhappiness), negative self-view (e.g., feelings of worthlessness, self-criticism), loneliness and social alienation, and reduced positive affect and engagement (e.g., difficulty having fun, loss of enjoyment).
Measured: Baseline/0 month, Treatment End/3 months
Psychological distress / Anxiety
Symptoms of anxiety will be assessed with 29-item Patient Reported Outcomes Measurement Information System (PROMIS) Adult Anxiety Scale, a self-report measure assessing fear (e.g., fearfulness, feelings of panic), anxious misery (e.g., worry, dread), hyperarousal (e.g., tension, nervousness, restlessness), and somatic symptoms related to arousal (e.g., cardiovascular symptoms, dizziness).
Measured: Baseline/0 month, Treatment End/3 months
Mindfulness
Mindfulness will be measured using the 39-item Five Facet Mindfulness Questionnaire (FFMQ), a self-report measure assessing five behaviors associated with mindfulness: observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience.
Measured: Baseline/0 month, Treatment End/3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start31 Oct 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, April Carcone, Wayne State University
- Investigators
- April Idalski Carcone, PhD, MSW, Principal investigator, Wayne State UniversityErica MS Sibinga, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793097
- Sponsor's protocol ID
- IRB-25-05-7727
- Other IDs
- R01DK141816
- Acronym
- MBSR-VR
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data produced during the project will be preserved and shared under a fully executed data use agreement. IPD data will include non-identifying demographics, biomedical, psychological, behavioral, and treatment delivery information. The final patient level dataset will include demographics, primary and secondary outcomes as well as mediators and treatment delivery data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of MBSR-VR to Reduce Stress Among Emerging Adults With T1D
- ClinicalTrials.gov ID
- NCT07793097
- Acronym / sponsor ID
- MBSR-VR / IRB-25-05-7727
- Conditions
- Type 1 Diabetes
- Keywords
- mindfulness, emerging adults, stress, diabetes, MBSR, virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this research is to assess the feasibility of a highly scalable intervention, Mind-fulness-Based Stress Reduction (MBSR) delivered virtually enhanced with virtual reality (VR), for improving health outcomes through the reduction of stress in a high-risk population, emerging adults (EAs; 16-20 years) with high levels of stress reactivity. The primary aim of this project is to adapt MBSR for virtual delivery enhanced with VR in collaboration with a Youth Community Advisory Board (YCAB, composed of five EAs with T1D) and to assess feasibility and the acceptability of MBSR-VR for EAs with T1D and elevated levels of stress reactivity. This feasibility study will use a multi-center randomized controlled pilot study design with 48 EAs with T1D and elevated stress (as as-sessed with the Perceived Stress Reactivity Scale). EAs will be randomized in a 1:1 ratio to MBSR-VR or treat-ment as usual (TAU, standard care control). Three cohorts of 16 participants, 48 total, will be enrolled through two clinical research centers (CRCs) at Wayne State University (WSU) in Detroit, Michigan and Johns Hopkins University (JHU) in Baltimore, Maryland. The WSU site will recruit via the T1D Exchange (T1DX) and JHU via their affiliate diabetes clinics. Participants will enter the study during an 8-week period during which research staff will obtain informed consent and assess eligibility via a stress screener; eligible participants will continue with their baseline data collection (T1). Once 16 participants have enrolled, they will be randomized in a single block, 8 to MBSR and 8 to TAU, and those assigned to MBSR will be oriented to the VR technology. All partici-pants will continue to receive standard medical care from their usual diabetes care provider. Treatment groups will run for 9 weeks followed by a 4-week post-treatment data collection (T2) period. The YCAB will assist with monitoring study progress and refining study procedures (e.g., recruitment strategies) over the course of the trial. Feasibility and acceptability will be established through achieving recruitment, retention and intervention bench-marks. Recruitment feasibility will be established by accruing 8 participants every 4 weeks (16 over 8 weeks) and fewer than 15% excluded due to lack of access to an internet-enabled device. Retention feasibility will be established with 85% retention at the end of treatment data collection and <15% of dropouts due to technology challenges that impeded study participation. Intervention feasibility will be established if EAs attend ≥5 of 9 MSBR intervention sessions, ≥90% of the intervention content is delivered, staff collect >75% of self-practice diaries, MBSR fidelity ratings are ≥4 out of 5 on average, and EAs express satisfaction via qualitative interviews and quantitative assessment (≥3 out of 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR-VR | Experimental | Behavioral: Mindfulness-Based Stress Reduction - Virtual RealityParticipants 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. |
| Treatment as Usual (TAU) | Other | Other: Stress tip sheetEmerging 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. |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress Reduction - Virtual RealityAlso: MBSR-VRParticipants 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. | Behavioural | MBSR-VR |
| Stress tip sheetParticipants 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. | Other | Treatment as Usual (TAU) |
Primary outcome
Recruitment Feasibility / Number Screened
Time frame: From recruitment initiation to recruitment termination / 18 months
The ability to successfully identify and screen for study eligibility the target number of participants within the planned study timeline.
Recruitment Feasibility / Number Enrolled
Time frame: From recruitment initiation to recruitment termination / 18 months
The ability to successfully enroll the target number of participants within the planned study timeline.
Retention Feasibility / Number Retained
Time frame: From date of first participant enrollment to date of last participant completion / 18 months
The ability to successfully retain participants in the study.
Intervention Feasibility / Number of MBSR treatment sessions attended
Time frame: From date of treatment initiation to date of treatment termination / 9 weeks
Participants' willingness and ability to engage with and complete the intervention as designed.
Intervention Fidelity / Concise Fidelity for Mindfulness-Based Interventions (CoFi-MBI)
Time frame: From date of treatment initiation to date of treatment termination / 9 weeks
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.
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
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.
Glycemic control / Hemoglobin A1c (HbA1c)
Time frame: Baseline/0 month, Treatment End/3 months
Hb1Ac will be obtained by using the Accubase A1c test kit
Glycemic control / Mean blood glucose
Time frame: Baseline/0 month, Treatment End/3 months
Mean blood glucose will be obtained via 14-day manual download of glucometer data or direct download of continuous glucose monitor (CGM) data
6 secondary outcomes
Psychological distress / Stress Reactivity
Time frame: Baseline/0 month, Treatment End/3 months
Psychological distress / Perceived stress
Time frame: Baseline/0 month, Treatment End/3 months
Psychological distress / Diabetes-specific stress
Time frame: Baseline/0 month, Treatment End/3 months
Psychological distress / Depression
Time frame: Baseline/0 month, Treatment End/3 months
Psychological distress / Anxiety
Time frame: Baseline/0 month, Treatment End/3 months
Mindfulness
Time frame: Baseline/0 month, Treatment End/3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH RePORTER ListingLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified data produced during the project will be preserved and shared under a fully executed data use agreement. IPD data will include non-identifying demographics, biomedical, psychological, behavioral, and treatment delivery information. The final patient level dataset will include demographics, primary and secondary outcomes as well as mediators and treatment delivery data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
April Idalski Carcone, PhD, MSW principal investigator
Wayne State University
Erica MS Sibinga, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction - Virtual Reality and Stress tip sheet in people with Type 1 Diabetes, run by Wayne State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (1-313-577-6997, MBSR-VR@wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility / Number Screened (time frame: From recruitment initiation to recruitment termination / 18 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.