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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03999385
• Other study ID #: H2017:293
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2019
• Source: University of Manitoba
• Contact: Michael McIntyre, Ph.D.
• Phone: 1-204-235-3206
• Email: mmcintyre[@]sbrc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Mindful Self-Compassion (MSC)
The MSC program was developed by Christopher K. Germer, PhD and Kristin Neff, PhD.

Locations

Country	Name	City	State
Canada	St. Boniface Hospital Research Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	The Lawson Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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