Clinical trial NCT03999385: Mindful Self-Compassion to Assist Emerging Adults With Diabetes Transition to Adulthood
Official title: Growth and Self-Care: The Use of Mindfulness-Based Interventions to Assist Emerging Adults With Diabetes Transition to Adulthood
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Mindfulness
Mindful Self-compassion
Self-compassion
Diabetes
Self-care
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: The Lawson Foundation
First posted: 2019-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pretest-Posttest Waitlist Control Design
Primary purpose: SUPPORTIVE_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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in average plasma glucose concentration
timeFrame: Baseline, 8 weeks, and 3 months
measure: Change in diabetes self-management
timeFrame: Baseline, 8 weeks, and 3 months
Secondary outcomes:
measure: Change in Self-compassion
timeFrame: Baseline, 8 weeks, and 3 months
measure: Change in Mindfulness
timeFrame: Baseline, 8 weeks, and 3 months
measure: Change in Fears of Compassion
timeFrame: Baseline, 8 weeks, and 3 months
measure: Change in Positive Affect
timeFrame: Baseline, 8 weeks, and 3 months
measure: Change in Negative Affect
timeFrame: Baseline, 8 weeks, and 3 months
measure: Change in Perceived Stress
timeFrame: Baseline, 8 weeks, and 3 months
measure: Change in Life Engagement
timeFrame: Baseline, 8 weeks, and 3 months
measure: Change in Health Locus of Control
timeFrame: Baseline, 8 weeks, and 3 months
measure: Change in Eating Disorder Symptomatology
timeFrame: Baseline, 8 weeks, and 3 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface Hospital Research Centre
state: Manitoba
Study officials:
affiliation: St. Boniface Hospital Research Centre
name: Michael McIntyre, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: