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

Sponsor
University of Manitoba (Other)
Overall Status
Unknown status
CT.gov ID
NCT03999385
Collaborator
The Lawson Foundation (Other)
60
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2
23.3
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindful Self-Compassion (MSC)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pretest-Posttest Waitlist Control DesignPretest-Posttest Waitlist Control Design
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Growth and Self-Care: The Use of Mindfulness-Based Interventions to Assist Emerging Adults With Diabetes Transition to Adulthood
Actual Study Start Date :
Jun 24, 2019
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Immediate Training Group

8 weeks of training in Mindful Self-Compassion.

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

Other: Waitlist Control Group

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

Outcome Measures

Primary Outcome Measures

  1. Change in average plasma glucose concentration [Baseline, 8 weeks, and 3 months]

    Assessed by HbA1C test results. The desired outcome is a statistically significant decrease in average glucose concentration, indicating greater diabetes management.

  2. Change in diabetes self-management [Baseline, 8 weeks, and 3 months]

    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.

Secondary Outcome Measures

  1. Change in Self-compassion [Baseline, 8 weeks, and 3 months]

    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.

  2. Change in Mindfulness [Baseline, 8 weeks, and 3 months]

    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.

  3. Change in Fears of Compassion [Baseline, 8 weeks, and 3 months]

    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.

  4. Change in Positive Affect [Baseline, 8 weeks, and 3 months]

    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.

  5. Change in Negative Affect [Baseline, 8 weeks, and 3 months]

    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.

  6. Change in Perceived Stress [Baseline, 8 weeks, and 3 months]

    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.

  7. Change in Life Engagement [Baseline, 8 weeks, and 3 months]

    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.

  8. Change in Health Locus of Control [Baseline, 8 weeks, and 3 months]

    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.

  9. Change in Eating Disorder Symptomatology [Baseline, 8 weeks, and 3 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Boniface Hospital Research Centre Winnipeg Manitoba Canada R2H 2A6

Sponsors and Collaborators

  • University of Manitoba
  • The Lawson Foundation

Investigators

  • Principal Investigator: Michael McIntyre, Ph.D., St. Boniface Hospital Research Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael McIntyre, Principal Investigator, University of Manitoba
ClinicalTrials.gov Identifier:
NCT03999385
Other Study ID Numbers:
  • H2017:293
First Posted:
Jun 26, 2019
Last Update Posted:
Jun 26, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michael McIntyre, Principal Investigator, University of Manitoba
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2019