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| Name | Class |
|---|---|
| The Lawson Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Training Group | Experimental | 8 weeks of training in Mindful Self-Compassion. |
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| Waitlist Control Group | Other | No intervention for approximately 12 weeks. After this waiting period, participants will complete 8 weeks of training in Mindful Self-Compassion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful Self-Compassion (MSC) | Behavioral | The MSC program was developed by Christopher K. Germer, PhD and Kristin Neff, PhD. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in average plasma glucose concentration | Assessed by HbA1C test results. The desired outcome is a statistically significant decrease in average glucose concentration, indicating greater diabetes management. | Baseline, 8 weeks, and 3 months |
| Change in diabetes self-management | 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. | Baseline, 8 weeks, and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-compassion | 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. | Baseline, 8 weeks, and 3 months |
| Change in Mindfulness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael McIntyre, Ph.D. | Contact | 1-204-235-3206 | mmcintyre@sbrc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael McIntyre, Ph.D. | St. Boniface Hospital Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Boniface Hospital Research Centre | Recruiting | Winnipeg | Manitoba | R2H 2A6 | Canada |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Pretest-Posttest Waitlist Control Design
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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. |
| Baseline, 8 weeks, and 3 months |
| Change in Fears of Compassion | 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. | Baseline, 8 weeks, and 3 months |
| Change in Positive Affect | 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. | Baseline, 8 weeks, and 3 months |
| Change in Negative Affect | 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. | Baseline, 8 weeks, and 3 months |
| Change in Perceived Stress | 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. | Baseline, 8 weeks, and 3 months |
| Change in Life Engagement | 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. | Baseline, 8 weeks, and 3 months |
| Change in Health Locus of Control | 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. | Baseline, 8 weeks, and 3 months |
| Change in Eating Disorder Symptomatology | 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. | Baseline, 8 weeks, and 3 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |