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).

• Mindfulness-Based Stress Reduction - Virtual Reality (Behavioral), also known as 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 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.

Primary outcomes

• Recruitment Feasibility / Number Screened [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 [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 [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 [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) [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) [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) [Baseline/0 month, Treatment End/3 months]: Hb1Ac will be obtained by using the Accubase A1c test kit
• Glycemic control / Mean blood glucose [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

Secondary outcomes

• Psychological distress / Stress Reactivity [Baseline/0 month, Treatment End/3 months]: 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".
• Psychological distress / Perceived stress [Baseline/0 month, Treatment End/3 months]: General psychological stress will be measured with the 10-item Perceived Stress Scale (PSS), a self-report questionnaire assessing perceptions of stress.
• Psychological distress / Diabetes-specific stress [Baseline/0 month, Treatment End/3 months]: 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.
• Psychological distress / Depression [Baseline/0 month, Treatment End/3 months]: 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).
• Psychological distress / Anxiety [Baseline/0 month, Treatment End/3 months]: 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).
• Mindfulness [Baseline/0 month, Treatment End/3 months]: 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.

Sex: All, ages: 16 Years to 20 Years

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

• April Idalski Carcone, PhD, MSW, Principal investigator, Wayne State University
• Erica MS Sibinga, MD, Principal investigator, Johns Hopkins University

NIH grants: R01DK141816