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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-20
SponsorWayne State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness-Based Stress Reduction - Virtual Reality

    Behavioral

    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 intervention

    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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: MBSR-VRExperimental treatment 1 intervention
Group B: Treatment as Usual (TAU)Other 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Feasibility / Number Screened

The ability to successfully identify and screen for study eligibility the target number of participants within the planned study timeline.

Time frame
From recruitment initiation to recruitment termination / 18 months
2

Recruitment Feasibility / Number Enrolled

The ability to successfully enroll the target number of participants within the planned study timeline.

Time frame
From recruitment initiation to recruitment termination / 18 months
3

Retention Feasibility / Number Retained

The ability to successfully retain participants in the study.

Time frame
From date of first participant enrollment to date of last participant completion / 18 months
4

Intervention Feasibility / Number of MBSR treatment sessions attended

Participants' willingness and ability to engage with and complete the intervention as designed.

Time frame
From date of treatment initiation to date of treatment termination / 9 weeks

Secondary outcomes

1

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".

Time frame
Baseline/0 month, Treatment End/3 months
2

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.

Time frame
Baseline/0 month, Treatment End/3 months
3

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.

Time frame
Baseline/0 month, Treatment End/3 months
4

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).

Time frame
Baseline/0 month, Treatment End/3 months

Other outcomes

Sponsors and contacts

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Wayne State University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

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