None listed
Conditions
Brief summary
This study aims to explore the efficacy of in-person and online MBSR for improving mental health and metabolic profile in diabetes patients living in regional and rural north Queensland using a RCT design. Our study will answer three research questions: 1) Is in-person MBSR efficacious for improving mental health and metabolic profile in diabetes patients? 2) Is online MBSR efficacious for improving mental health and metabolic profile in diabetes patients? 3) Are mental health benefits observed after 4- and 6-week interventions?
Interventions
The MBSR intervention will be delivered by A/Prof Wendy Li, a qualified MBSR teacher certified by the Mindfulness Center at Brown University, with more than 15-year meditation experience. The in-person and online MBSR groups will meet once per week (2.5 hours per session) for 8 weeks, plus a 6-hour teacher-guided retreat session on the Saturday of Week 6, in person or via zoom, respectively, At least one medical practitioner or clinical psychologist will be on site during the intervention to provide clinical support to participants if needed. The current RCT is a trial in which subjects are randomly assigned to one of three groups: one in-person MBSR group and one online MBSR group receiving the in-person and online MBSR intervention, respectively, which are being tested. The third group is the waiting list control group, receiving no treatments during the research duration, but receiving online MBSR intervention after the data collection completed. The Brown University Mindfulness Centre’s Mindfulness-Based Stress Reduction (MBSR) Curriculum and Teaching Guide (2019) will be used to guide the MBSR intervention. The main guided meditation practices included in the curriculum are: 1) Eating meditation, which is a practice offers guidance in seeing, feeling, hearing and tasting the raisin in silence. Eating, as an ordinary activity in daily life, can support slowing down to allow time for various senses (e.g., smell, taste, hear) to register what is being received, time to gather the evidence of what this experience of eating actually is like. 2) Body-scan meditation, which emphasises “being in the body” to develop both concentration and flexibility of attention. It involves lying on the back, gradually moving attention through the body accompanied by awareness of breathing and other bodily sensations. 3) Sitting and attention focus meditation, where participants sit upright on a chair or cushion, during which attention is drawn to breathing. 4) Mindful hatha yoga, which consists of gentle stretching and strengthening exercises, moving very slowly, with moment-to-moment awareness of breathing and of the sensations during movement. 5) Walking mediation, which involves intentionally attending to the experience of walking itself, focusing on the sensations in the feet, legs and whole body while walking, and integrating awareness of breathing with the experience of walking. Both in-person and online MBSR groups will employ the same MBSR curriculum. Two guided mindfulness meditations will be delivered every week: W1 - Eating medication and body scan; W2 - attention focus meditation and body scan; W3 - Lying down yoga and sitting meditation; W4 - Standing yoga and sitting meditation with more silence; W5 - Lying down Yoga and sitting meditation with more silence; W6 - Standing Yoga and sitting meditation with more silence; W7 - Walking meditation and sitting meditation with more silence; W8 - Body scan and sitting meditation with more silence. Session attendance checklists will be used to monitor adherence to the intervention. Participants will be given guided meditation audio recordings to practice at home for 20-30 min, 6 days a week as homework assignments. In-class material emphasising the systematic development of mindfulness and its application in everyday life will be given. Additional discussion, which focuses on the psychology and physiology of stress reactivity and the application of mindfulness as a method for responding positively to stress, will be held in the class. Participants in both intervention groups (The in-person and online MBSR) will be discouraged from making any changes in medication from the time of randomisation until after the follow-up assessment. Participants in the waiting list control group will be offered the MBSR intervention after the study is complete. MBSR is considered as relatively safe, but ethical aspects should be considered. Participants may experience stress and discomfort during the process of psychological change. Unwanted thoughts, emotions, and sensations may arise during the meditation practices. To minimise the discomfort, an individual pre-intervention interview will be held one month before commencing the intervention where the researcher will discuss these difficulties and provide a clear rationale for how the program may help with participants' concerns. During the intervention, the instructor will remind participants not to push beyond limits of safety or tolerance and suggest ways to adapt practices if difficulties that feel overwhelming arise (e.g., opening the eyes or changing position to stabilize emotions and body sensations).
Sponsors
Study design
Eligibility
Inclusion criteria
Patients who 1) are aged 18 years or over; 2) have been diagnosed with Type 1 or Type 2 diabetes for at least 6 months; 3) have a stable antidiabetic medication dosage; and 4) speak fluent English and have attained at least a Year Seven reading ability.
Exclusion criteria
Patients who 1) experience significant comorbidities including cardiac, respiratory, or renal failures; 2) malignancies other than basal cell carcinoma; 3) current substance dependence (as measured by DSM-V criteria); 4) current psychotic disorder (e.g., schizophrenia, bipolar disorder); 5) prominent current suicidal ideation; 6) change in dosage, or began new, psychotropic medication in the previous 2 months; 7) a severe cognitive disorder (e.g., dementia or severe traumatic brain injury); 8) a clinically significant unstable or severe medical condition; and 9) prior participation in a MBSR program.