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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindful Self-Compassion (MSC)
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Mindfulness, Mindful Self-compassion, Self-compassion, Diabetes, Self-care

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Boniface Hospital Research CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate Training Group

Waitlist Control Group

Arm Description

8 weeks of training in Mindful Self-Compassion.

No intervention for approximately 12 weeks. After this waiting period, participants will complete 8 weeks of training in Mindful Self-Compassion.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 24, 2019
Last Updated
June 24, 2019
Sponsor
University of Manitoba
Collaborators
The Lawson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03999385
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
The Lawson Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Mindfulness, Mindful Self-compassion, Self-compassion, Diabetes, Self-care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pretest-Posttest Waitlist Control Design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Training Group
Arm Type
Experimental
Arm Description
8 weeks of training in Mindful Self-Compassion.
Arm Title
Waitlist Control Group
Arm Type
Other
Arm Description
No intervention for approximately 12 weeks. After this waiting period, participants will complete 8 weeks of training in Mindful Self-Compassion.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Self-Compassion (MSC)
Intervention Description
The MSC program was developed by Christopher K. Germer, PhD and Kristin Neff, PhD.
Primary Outcome Measure Information:
Title
Change in average plasma glucose concentration
Description
Assessed by HbA1C test results. The desired outcome is a statistically significant decrease in average glucose concentration, indicating greater diabetes management.
Time Frame
Baseline, 8 weeks, and 3 months
Title
Change in diabetes self-management
Description
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.
Time Frame
Baseline, 8 weeks, and 3 months
Secondary Outcome Measure Information:
Title
Change in Self-compassion
Description
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.
Time Frame
Baseline, 8 weeks, and 3 months
Title
Change in Mindfulness
Description
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.
Time Frame
Baseline, 8 weeks, and 3 months
Title
Change in Fears of Compassion
Description
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.
Time Frame
Baseline, 8 weeks, and 3 months
Title
Change in Positive Affect
Description
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.
Time Frame
Baseline, 8 weeks, and 3 months
Title
Change in Negative Affect
Description
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.
Time Frame
Baseline, 8 weeks, and 3 months
Title
Change in Perceived Stress
Description
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.
Time Frame
Baseline, 8 weeks, and 3 months
Title
Change in Life Engagement
Description
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.
Time Frame
Baseline, 8 weeks, and 3 months
Title
Change in Health Locus of Control
Description
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.
Time Frame
Baseline, 8 weeks, and 3 months
Title
Change in Eating Disorder Symptomatology
Description
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.
Time Frame
Baseline, 8 weeks, and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael McIntyre, Ph.D.
Phone
1-204-235-3206
Email
mmcintyre@sbrc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael McIntyre, Ph.D.
Organizational Affiliation
St. Boniface Hospital Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface Hospital Research Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael McIntyre, Ph.D.
Phone
1-204-235-3206
Email
mmcintyre@sbrc.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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

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