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

NCT ID: NCT03999385

Last Updated: 2019-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-24

Study Completion Date

2021-06-01

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pretest-Posttest Waitlist Control Design
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Immediate Training Group

8 weeks of training in Mindful Self-Compassion.

Group Type EXPERIMENTAL

Mindful Self-Compassion (MSC)

Intervention Type BEHAVIORAL

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

Waitlist Control Group

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

Group Type OTHER

Mindful Self-Compassion (MSC)

Intervention Type BEHAVIORAL

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

Interventions

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Mindful Self-Compassion (MSC)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Lawson Foundation

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Michael McIntyre

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael McIntyre, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

St. Boniface Hospital Research Centre

Locations

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St. Boniface Hospital Research Centre

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Michael McIntyre, Ph.D.

Role: CONTACT

1-204-235-3206

Facility Contacts

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Michael McIntyre, Ph.D.

Role: primary

1-204-235-3206

Other Identifiers

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H2017:293

Identifier Type: -

Identifier Source: org_study_id

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