Mindfulness for Adolescents With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

The Effects of Learning Mindfulness Based Stress Reduction on Psychosocial Variables and HbA1c in Adolescents With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03942471
• Other study ID #: 2015/10/14
• Status: Completed
• Phase: N/A
• Start date: October 14, 2015
• Est. completion date: January 5, 2019

Study information

• Verified date: May 2019
• Source: Duquesne University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 5, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

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

-

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duquesne University

References & Publications (2)

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. — View Citation

Ingersoll GM, Marrero DG. A modified quality-of-life measure for youths: psychometric properties. Diabetes Educ. 1991 Mar-Apr;17(2):114-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mindful Attention Awareness Measurements after Mindfulness Training	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)
Primary	Change in Diabetes Quality of Life: DQOL-Y Measurements after Mindfulness Training	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)
Primary	Change in HbA1c Measurements after Mindfulness Training	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)