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

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).

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