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

June 24, 2019 updated by: Michael McIntyre, University of Manitoba

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Michael McIntyre, Ph.D.
  • Phone Number: 1-204-235-3206
  • Email: mmcintyre@sbrc.ca

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Recruiting
        • St. Boniface Hospital Research Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in average plasma glucose concentration
Time Frame: 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.
Baseline, 8 weeks, and 3 months
Change in diabetes self-management
Time Frame: 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.
Baseline, 8 weeks, and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Self-compassion
Time Frame: 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.
Baseline, 8 weeks, and 3 months
Change in Mindfulness
Time Frame: 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.
Baseline, 8 weeks, and 3 months
Change in Fears of Compassion
Time Frame: 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.
Baseline, 8 weeks, and 3 months
Change in Positive Affect
Time Frame: 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.
Baseline, 8 weeks, and 3 months
Change in Negative Affect
Time Frame: 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.
Baseline, 8 weeks, and 3 months
Change in Perceived Stress
Time Frame: 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.
Baseline, 8 weeks, and 3 months
Change in Life Engagement
Time Frame: 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.
Baseline, 8 weeks, and 3 months
Change in Health Locus of Control
Time Frame: 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.
Baseline, 8 weeks, and 3 months
Change in Eating Disorder Symptomatology
Time Frame: 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.
Baseline, 8 weeks, and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Lawson Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael McIntyre, Ph.D., St. Boniface Hospital Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H2017:293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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