Mindful Self-Compassion to Assist Emerging Adults With Diabetes Transition to Adulthood

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Growth and Self-Care: The Use of Mindfulness-Based Interventions to Assist Emerging Adults With Diabetes Transition to Adulthood

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: Mindful Self-Compassion (MSC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between the ages of 18 and 25 Obtain care for Type 1 diabetes Exclusion Criteria: Psychologically or medically unable to complete the MSC program

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pretest-Posttest Waitlist Control Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Training Group<br>8 weeks of training in Mindful Self-Compassion. | Behavioral: Mindful Self-Compassion (MSC)<br>* The MSC program was developed by Christopher K. Germer, PhD and Kristin Neff, PhD.<br>|
| Other: Waitlist Control Group<br>No intervention for approximately 12 weeks. After this waiting period, participants will complete 8 weeks of training in Mindful Self-Compassion. | Behavioral: Mindful Self-Compassion (MSC)<br>* The MSC program was developed by Christopher K. Germer, PhD and Kristin Neff, PhD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Mindful Self-compassion, Self-compassion, Diabetes, Self-care