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 virtualreality (VR), for improving health outcomes through the reduction of stress in ahigh‐risk population, emerging adults (EAs; 16‐20 years) with high levels of stressreactivity. The primary aim of this project is to adapt MBSR for virtual deliveryenhanced with VR in collaboration with a Youth Community Advisory Board (YCAB, composedof five EAs with T1D) and to assess feasibility and the acceptability of MBSR‐VR for EAswith T1D and elevated levels of stress reactivity. This feasibility study will use amulti‐center randomized controlled pilot study design with 48 EAs with T1D and elevatedstress (as as‐sessed with the Perceived Stress Reactivity Scale). EAs will be randomizedin a 1:1 ratio to MBSR‐VR or treat‐ment as usual (TAU, standard care control). Threecohorts of 16 participants, 48 total, will be enrolled through two clinical researchcenters (CRCs) at Wayne State University (WSU) in Detroit, Michigan and Johns HopkinsUniversity (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 studyduring an 8‐week period during which research staff will obtain informed consent andassess eligibility via a stress screener; eligible participants will continue with theirbaseline data collection (T1). Once 16 participants have enrolled, they will berandomized in a single block, 8 to MBSR and 8 to TAU, and those assigned to MBSR will beoriented to the VR technology. All partici‐pants will continue to receive standardmedical care from their usual diabetes care provider. Treatment groups will run for 9weeks followed by a 4‐week post‐treatment data collection (T2) period. The YCAB willassist with monitoring study progress and refining study procedures (e.g., recruitmentstrategies) over the course of the trial. Feasibility and acceptability will beestablished through achieving recruitment, retention and intervention bench‐marks.Recruitment feasibility will be established by accruing 8 participants every 4 weeks (16over 8 weeks) and fewer than 15% excluded due to lack of access to an internet‐enableddevice. Retention feasibility will be established with 85% retention at the end oftreatment data collection and <15% of dropouts due to technology challenges that impededstudy participation. Intervention feasibility will be established if EAs attend ≥5 of 9MSBR 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 EAsexpress satisfaction via qualitative interviews and quantitative assessment (≥3 out of4).