Mindful Self-Compassion to Assist Emerging Adults With Diabetes Transition to Adulthood
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Behavioral: Mindful Self-Compassion (MSC)
- Registration Number
- NCT03999385
- Lead Sponsor
- University of Manitoba
- Brief Summary
The transition from pediatric to adult care is particularly difficult for individuals with Type 1 diabetes. It is hypothesized that a mindfulness-based intervention for individuals making this transition will contribute to personal psychological well-being, superior participation in health care, and more tightly controlled blood sugar levels. Young adults with Type I diabetes will complete an eight-week training program in Mindful Self-Compassion. Intervention effectiveness will be assessed with both self-report and physiological measures. Assessments will occur at the start of the training program, end of the program, and three-months post-program.
- Detailed Description
This research will evaluate the consequences of an eight-week Mindful Self-Compassion (MSC) intervention on the psychological and physical well-being of 18 to 25 year-old individuals with Type 1 diabetes who are at an age of established risk. Participants will be randomly assigned to either an immediate intervention group or wait-list control group. All participants will be tested before and after the intervention on a battery of self-report measures designed to assess various aspects of self-care and psychological functioning. Blood samples will also be taken before and after the intervention to determine HbA1C levels. Participants will also receive a followup assessment three-months post-intervention to assess the durability of the effects. We expect MSC training to induce positive change in participants' diabetes management and personal well-being.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Adults between the ages of 18 and 25
- Obtain care for Type 1 diabetes
- Psychologically or medically unable to complete the MSC program
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate Training Group Mindful Self-Compassion (MSC) 8 weeks of training in Mindful Self-Compassion. Waitlist Control Group Mindful Self-Compassion (MSC) No intervention for approximately 12 weeks. After this waiting period, participants will complete 8 weeks of training in Mindful Self-Compassion.
- Primary Outcome Measures
Name Time Method Change in average plasma glucose concentration Baseline, 8 weeks, and 3 months Assessed by HbA1C test results. The desired outcome is a statistically significant decrease in average glucose concentration, indicating greater diabetes management.
Change in diabetes self-management Baseline, 8 weeks, and 3 months Assessed by total scores and subscale scores on the Summary of Diabetes Self-Care Activities (Toobert, Hampson, \& Glasgow, 2000), which range from 0 to 7 when item scores are averaged. The items assess general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. The desired outcome is a statistically significant increase in diabetes self-management.
- Secondary Outcome Measures
Name Time Method Change in Negative Affect Baseline, 8 weeks, and 3 months Assessed by scores on the negative affect subscale of the Positive and Negative Affect Schedule (Watson, Clark, \& Tellegen, 1988), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant decrease in negative affect.
Change in Life Engagement Baseline, 8 weeks, and 3 months Assessed by total scores on the Life Engagement Test (Scheier et al., 2006), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant increase in life engagement.
Change in Eating Disorder Symptomatology Baseline, 8 weeks, and 3 months Assessed by total scores and subscale scores on the Eating Disorders Examination Questionnaire (Fairburn \& Beglin, 1994), which range from 0 to 6 when item scores are averaged. The desired outcome is a statistically significant decrease in eating disorder symptomatology.
Change in Mindfulness Baseline, 8 weeks, and 3 months Assessed by total scores and subscale scores on the Five Facet Mindfulness Questionnaire (Baer et al., 2006), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant increase in mindfulness.
Change in Fears of Compassion Baseline, 8 weeks, and 3 months Assessed by total scores and subscale scores on the Fears of Compassion Scales (Gilbert et al., 2011), which range from 0 to 4 when item scores are averaged. The desired outcome is a statistically significant decrease in fears of compassion.
Change in Positive Affect Baseline, 8 weeks, and 3 months Assessed by total scores on the Positive Affective Well-Being scale (Hess et al., 2005; score range: 1 to 7) and scores on the positive affect subscale of the Positive and Negative Affect Schedule (Watson, Clark, \& Tellegen, 1988; score range: 1 to 5). The desired outcome is a statistically significant increase in positive affect.
Change in Self-compassion Baseline, 8 weeks, and 3 months Assessed by total scores and subscale scores on the Self-Compassion Scale (Neff, 2003), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant increase in self-compassion.
Change in Perceived Stress Baseline, 8 weeks, and 3 months Assessed by total scores on the Perceived Stress Scale (Cohen et al., 1983), which range from 1 to 5 when item scores are averaged. The desired outcome is a statistically significant decrease in perceived stress.
Change in Health Locus of Control Baseline, 8 weeks, and 3 months Assessed by subscale scores (internal, chance, powerful others) on the Multidimensional Health Locus of Control Scale (Wallston et al., 1978), which range from 1 to 6 when item scores are averaged. The desired outcome is a statistically significant increase in internal health locus of control.
Trial Locations
- Locations (1)
St. Boniface Hospital Research Centre
🇨🇦Winnipeg, Manitoba, Canada