- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03942471
Mindfulness for Adolescents With Type 1 Diabetes
May 6, 2019 updated by: Duquesne University
The Effects of Learning Mindfulness Based Stress Reduction on Psychosocial Variables and HbA1c in Adolescents With Type 1 Diabetes
Adolescents with Type 1 Diabetes will be invited to the Mindfulness study.
They will be randomly assigned to a Control or Active Group.
The Active Group will learn Mindfulness Based Stress Reduction (MBSR) through an online website designed to teach the basic principles of MBSR in six week-long modules.
They will be measured in three main areas: before learning the intervention, directly after learning it and 3 months after learning it to determine any changes in their Mindful attention awareness, Diabetes Quality of Life and HbA1c.
The Control Group will also take the questionnaires at the beginning of the study, 6 weeks after it begins and then 3 months from the beginning to obtain data for all three time points when they have not received access to the modules/intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Research Design and Procedures This study will utilize a between group repeated measures design to measure the effects of the learned MBSR intervention over time.
MBSR will be the independent variable.
Dependent variables include mindfulness, diabetic quality of life and HbA1c.
Adolescents with Type 1 diabetes will be randomly assigned to an intervention group or a wait list/control group that will be taught MBSR after all data has been collected.
The study will utilize a 2 (experimental versus wait-list control group) by 3 (pretest [Time 1], posttest [Time 2], and 3 month follow-up [Time 3]) to examine within and between group differences overtime on two psychosocial measures including mindfulness and quality of life.
The physiological measure understudy, HbA1c, reflects glucose control over the previous three month period and will be measured at Time 1 and Time 3. MBSR training will be provided via an online website and secure data collection site called MySweetMind.org.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
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
Ages Eligible for Study
12 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adolescents between the ages of 12 - 19
- Diagnosis of Type 1 Diabetes
- Fluent in English
- No diagnosed cognitive impairments
- 6th grade education completion
- Access to a Computer
- Access to the internet
Exclusion Criteria: under 12, over 19 - no access to a computer/internet
-
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: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention Mindfulness Based Stress Reduction
Six Modules each delivering an important principle of Mindfulness Based Stress Reduction
|
Mindfulness-Based Stress Reduction (MBSR) is a well-defined and systematic patient-centered educational approach which provides training in mindfulness meditation to teach adolescents with Type 1 diabetes to take better care of themselves and live healthier and more adaptive lives by learning to become more connected to the present moment through the use of breath and training for awareness of the moment.
Other Names:
|
No Intervention: Control Group
Wait Group - received no mindfulness teaching
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mindful Attention Awareness Measurements after Mindfulness Training
Time Frame: Time 1 (Baseline), Time 2 (6 weeks post intervention) and Time 3 (3 months post intervention)
|
Mindful Attention Awareness Adolescents Questionnaire developed by Brown, et al. (2011) to assess mindfulness in adolescents.
The rapid increase in mindfulness based interventions for children and adolescents led the developers to modify the MAAS to measure mindfulness in this age group.
It consists of 14 items that measure the level of mindfulness measured on a six-point scale with 1 (almost always) to 6 (almost never).
Higher scores are an indication of more mindfulness in which there is a receptive state of mind to the present.
The MAAS-A has been found to correlate with psychological well-being and healthy self-regulation and does measure the effects of mindfulness training.
Mindful Attention Awareness will be measured three times to determine if there is a change in scores from Time 1 to Time 2 to Time 3
|
Time 1 (Baseline), Time 2 (6 weeks post intervention) and Time 3 (3 months post intervention)
|
Change in Diabetes Quality of Life: DQOL-Y Measurements after Mindfulness Training
Time Frame: Time 1 (Baseline), Time 2 (6 weeks post intervention) and Time 3 (3 months post intervention)
|
Diabetes Quality of Life - Youth Questionnaire (Ingersoll & Marrero, 1991) developed a modified version of the DQOL called the Diabetes Quality of Life for Youth (DQOL-Y).
This questionnaire consists of 52 items with three subscales: Diabetes Life Satisfaction scale (17 items) with scores from 1 (very satisfied) to 5 (very dissatisfied), Disease Impact scale (23 items) with scores from 1 (never) to 5 (all the time), and Disease-Related Worries scale (11 items) with scores from 0 (does not apply) to 5 (all the time).
Lower scores are indicative of higher quality of life.
Also, included at the end is a general self-rating of overall health.
In this study, quality of life was analyzed using the summation of each of these sub categories (impact, worry, and satisfaction to obtain a total DQOL score.
Reliability of the DQOL-Y was tested for both adolescents and adults.
The Diabetes Quality of Life questionnaire will be administered three times to determine whether or not there is a change
|
Time 1 (Baseline), Time 2 (6 weeks post intervention) and Time 3 (3 months post intervention)
|
Change in HbA1c Measurements after Mindfulness Training
Time Frame: Time 1 (Baseline) and Time 3 (3 months post intervention)
|
HbA1c measurement with fingerstick droplet of blood tested.
The instant HbA1c required a drop of blood from the finger stick that provided results in less than 10 minutes.
Less affected by the day to day variations in blood glucose readings, the HbA1c returns values which are representative of an average blood glucose over a 90 day period.
The HbA1c will be administered two times to determine whether or not there is a change between Time 1 and Time 3.
|
Time 1 (Baseline) and Time 3 (3 months post intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Linda Goodfellow, Duquesne University
- Study Director: Fran Cogen, MD, George Washington University School of Medicine and Health Sciences
- Study Director: Jessica Devido, PhD, Duquesne University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Brown KW, West AM, Loverich TM, Biegel GM. Assessing adolescent mindfulness: validation of an adapted Mindful Attention Awareness Scale in adolescent normative and psychiatric populations. Psychol Assess. 2011 Dec;23(4):1023-33. doi: 10.1037/a0021338. Epub 2011 Feb 14.
- Ingersoll GM, Marrero DG. A modified quality-of-life measure for youths: psychometric properties. Diabetes Educ. 1991 Mar-Apr;17(2):114-8. doi: 10.1177/014572179101700219.
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)
October 14, 2015
Primary Completion (Actual)
October 1, 2018
Study Completion (Actual)
January 5, 2019
Study Registration Dates
First Submitted
March 29, 2019
First Submitted That Met QC Criteria
May 6, 2019
First Posted (Actual)
May 8, 2019
Study Record Updates
Last Update Posted (Actual)
May 8, 2019
Last Update Submitted That Met QC Criteria
May 6, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/10/14
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
product manufactured in and exported from the U.S.
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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