Diabetes Mellitus, Type 1NCT03999385
Mindful Self-Compassion to Assist Emerging Adults With Diabetes Transition to Adulthood
A study testing Mindful Self-Compassion (MSC) in people with Diabetes Mellitus, Type 1, run by University of Manitoba at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Mindful Self-Compassion (MSC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jun 2019to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults between the ages of 18 and 25
- Obtain care for Type 1 diabetes
Who cannot join
- Psychologically or medically unable to complete the MSC program
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Boniface Hospital Research Centre
Winnipeg, Manitoba, R2H 2A6
Michael McIntyre, Ph.D., 1-204-235-3206, mmcintyre@sbrc.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Mindful Self-Compassion (MSC)
- Keywords
- Mindfulness, Mindful Self-compassion, Self-compassion, Diabetes, Self-care
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Self-Compassion (MSC)Behavioural
The MSC program was developed by Christopher K. Germer, PhD and Kristin Neff, PhD.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Training Group | Experimental | 8 weeks of training in Mindful Self-Compassion. Receives: 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. Receives: Behavioral: Mindful Self-Compassion (MSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 8 weeks, and 3 months
Secondary outcomes (9)
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.
Measured: Baseline, 8 weeks, and 3 months
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.
Measured: Baseline, 8 weeks, and 3 months
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.
Measured: Baseline, 8 weeks, and 3 months
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.
Measured: Baseline, 8 weeks, and 3 months
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.
Measured: Baseline, 8 weeks, and 3 months
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.
Measured: Baseline, 8 weeks, and 3 months
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.
Measured: Baseline, 8 weeks, and 3 months
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.
Measured: Baseline, 8 weeks, and 3 months
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.
Measured: Baseline, 8 weeks, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start24 Jun 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pretest-Posttest Waitlist Control Design
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- The Lawson Foundation
- Responsible party
- Principal investigator, Michael McIntyre, University of Manitoba
- Investigators
- Michael McIntyre, Ph.D., Principal investigator, St. Boniface Hospital Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999385
- Sponsor's protocol ID
- H2017:293
- Status last verified
- Jun 2019
- First submitted
- 24 Jun 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Self-Care: The Use of Mindfulness-Based Interventions to Assist Emerging Adults With Diabetes Transition to Adulthood
- ClinicalTrials.gov ID
- NCT03999385
- Acronym / sponsor ID
- H2017:293
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Mindfulness, Mindful Self-compassion, Self-compassion, Diabetes, Self-care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- The Lawson Foundation
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pretest-Posttest Waitlist Control Design
| Arm | Type | Receives |
|---|---|---|
| Immediate Training Group | Experimental | Behavioral: Mindful Self-Compassion (MSC)8 weeks of training in Mindful Self-Compassion. |
| Waitlist Control Group | Other | Behavioral: Mindful Self-Compassion (MSC)No intervention for approximately 12 weeks. After this waiting period, participants will complete 8 weeks of training in Mindful Self-Compassion. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults between the ages of 18 and 25
- Obtain care for Type 1 diabetes
Key exclusion criteria (1 listed)
- Psychologically or medically unable to complete the MSC program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Self-Compassion (MSC)The MSC program was developed by Christopher K. Germer, PhD and Kristin Neff, PhD. | Behavioural | Immediate Training Group, Waitlist Control Group |
Primary outcome
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.
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.
9 secondary outcomes
Change in Self-compassion
Time frame: Baseline, 8 weeks, and 3 months
Change in Mindfulness
Time frame: Baseline, 8 weeks, and 3 months
Change in Fears of Compassion
Time frame: Baseline, 8 weeks, and 3 months
Change in Positive Affect
Time frame: Baseline, 8 weeks, and 3 months
Change in Negative Affect
Time frame: Baseline, 8 weeks, and 3 months
Change in Perceived Stress
Time frame: Baseline, 8 weeks, and 3 months
Change in Life Engagement
Time frame: Baseline, 8 weeks, and 3 months
Change in Health Locus of Control
Time frame: Baseline, 8 weeks, and 3 months
Change in Eating Disorder Symptomatology
Time frame: Baseline, 8 weeks, and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael McIntyre, Ph.D. principal investigator
St. Boniface Hospital Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Self-Compassion (MSC) in people with Diabetes Mellitus, Type 1, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael McIntyre, Ph.D. (1-204-235-3206, mmcintyre@sbrc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average plasma glucose concentration (time frame: Baseline, 8 weeks, and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.