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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03999385
Enrollment
60
Registered
2019-06-26
Start date
2019-06-24
Completion date
2021-06-01
Last updated
2019-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Mindfulness, Mindful Self-compassion, Self-compassion, Diabetes, Self-care

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.

Interventions

The MSC program was developed by Christopher K. Germer, PhD and Kristin Neff, PhD.

Sponsors

The Lawson Foundation
CollaboratorOTHER
University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Pretest-Posttest Waitlist Control Design

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in average plasma glucose concentrationBaseline, 8 weeks, and 3 monthsAssessed by HbA1C test results. The desired outcome is a statistically significant decrease in average glucose concentration, indicating greater diabetes management.
Change in diabetes self-managementBaseline, 8 weeks, and 3 monthsAssessed 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

MeasureTime frameDescription
Change in Fears of CompassionBaseline, 8 weeks, and 3 monthsAssessed 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 AffectBaseline, 8 weeks, and 3 monthsAssessed 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 Negative AffectBaseline, 8 weeks, and 3 monthsAssessed 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 Self-compassionBaseline, 8 weeks, and 3 monthsAssessed 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 Life EngagementBaseline, 8 weeks, and 3 monthsAssessed 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 Health Locus of ControlBaseline, 8 weeks, and 3 monthsAssessed 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.
Change in Eating Disorder SymptomatologyBaseline, 8 weeks, and 3 monthsAssessed 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 Perceived StressBaseline, 8 weeks, and 3 monthsAssessed 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 MindfulnessBaseline, 8 weeks, and 3 monthsAssessed 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.

Countries

Canada

Contacts

Primary ContactMichael McIntyre, Ph.D.
mmcintyre@sbrc.ca1-204-235-3206

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026