NCT03999385

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

1.9 years

First QC Date

June 24, 2019

Last Update Submit

June 24, 2019

Conditions

Diabetes Mellitus, Type 1

Keywords

MindfulnessMindful Self-compassionSelf-compassionDiabetesSelf-care

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, 8 weeks, and 3 months

  • 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.

    Baseline, 8 weeks, and 3 months

Secondary Outcomes (9)

  • Change in Self-compassion

    Baseline, 8 weeks, and 3 months

  • Change in Mindfulness

    Baseline, 8 weeks, and 3 months

  • Change in Fears of Compassion

    Baseline, 8 weeks, and 3 months

  • Change in Positive Affect

    Baseline, 8 weeks, and 3 months

  • Change in Negative Affect

    Baseline, 8 weeks, and 3 months

  • +4 more secondary outcomes

Study Arms (2)

Immediate Training Group

EXPERIMENTAL

8 weeks of training in Mindful Self-Compassion.

Behavioral: Mindful Self-Compassion (MSC)

Waitlist Control Group

OTHER

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)

Interventions

Mindful Self-Compassion (MSC)BEHAVIORAL

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

Immediate Training GroupWaitlist Control Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults between the ages of 18 and 25
  • Obtain care for Type 1 diabetes

You may not qualify if:

  • Psychologically or medically unable to complete the MSC program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface Hospital Research Centre

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Michael McIntyre, Ph.D.

    St. Boniface Hospital Research Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael McIntyre, Ph.D.

CONTACT

1-204-235-3206mmcintyre@sbrc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Pretest-Posttest Waitlist Control Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 26, 2019

Study Start

June 24, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

June 26, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)