Clinical trial NCT03942471: Mindfulness for Adolescents With Type 1 Diabetes
Official title: The Effects of Learning Mindfulness Based Stress Reduction on Psychosocial Variables and HbA1c in Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Duquesne University
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 65
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: between and within group repeated measures design
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

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Primary outcomes:
measure: Change in Mindful Attention Awareness Measurements after Mindfulness Training
timeFrame: Time 1 (Baseline), Time 2 (6 weeks post intervention) and Time 3 (3 months post intervention)
measure: Change in Diabetes Quality of Life: DQOL-Y Measurements after Mindfulness Training
timeFrame: Time 1 (Baseline), Time 2 (6 weeks post intervention) and Time 3 (3 months post intervention)
measure: Change in HbA1c Measurements after Mindfulness Training
timeFrame: Time 1 (Baseline) and Time 3 (3 months post intervention)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duquesne University
name: Linda Goodfellow
role: STUDY_CHAIR
affiliation: George Washington University School of Medicine and Health Sciences
name: Fran Cogen, MD
role: STUDY_DIRECTOR
affiliation: Duquesne University
name: Jessica Devido, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.