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

Feasibility of MBSR-VR to Reduce Stress Among Emerging Adults With T1D

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
16 Years to 20 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 9 weeks
  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Treatment groups will run for 9 weeks followed by a 4-week post-treatment data collection (T2) period."
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a mindfulness program can be offered through virtual reality (VR) to people ages 16–20 with type 1 diabetes who react strongly to stress. Mindfulness means paying attention to your thoughts, feelings, and surroundings. The study will look for changes in blood sugar, stress, mood, and mindfulness, but it is not designed to prove that the program improves them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 16–20 years old.
  • You have had type 1 diabetes for at least 6 months.
  • A stress questionnaire shows that you react strongly to stress.
  • You have a device with internet access for online study activities.

Who can't join

  • You have serious mental health or thinking problems that make it hard to take part in a group, such as schizophrenia, severe trouble thinking, or thoughts of harming yourself or others.
  • Your diabetes is caused by another long-term illness, such as cystic fibrosis, and needs care that is very different from usual type 1 diabetes care.
  • You are not fluent in English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

MD

MI