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Mindfulness for Adolescents With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Sponsored by
Duquesne University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    Intervention Mindfulness Based Stress Reduction

    Control Group

    Arm Description

    Six Modules each delivering an important principle of Mindfulness Based Stress Reduction

    Wait Group - received no mindfulness teaching

    Outcomes

    Primary Outcome Measures

    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
    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 29, 2019
    Last Updated
    May 6, 2019
    Sponsor
    Duquesne University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03942471
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 14, 2015 (Actual)
    Primary Completion Date
    October 1, 2018 (Actual)
    Study Completion Date
    January 5, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duquesne University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    between and within group repeated measures design
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Mindfulness Based Stress Reduction
    Arm Type
    Other
    Arm Description
    Six Modules each delivering an important principle of Mindfulness Based Stress Reduction
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Wait Group - received no mindfulness teaching
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness Based Stress Reduction
    Other Intervention Name(s)
    MBSR
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Mindful Attention Awareness Measurements after Mindfulness Training
    Description
    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 Frame
    Time 1 (Baseline), Time 2 (6 weeks post intervention) and Time 3 (3 months post intervention)
    Title
    Change in Diabetes Quality of Life: DQOL-Y Measurements after Mindfulness Training
    Description
    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 Frame
    Time 1 (Baseline), Time 2 (6 weeks post intervention) and Time 3 (3 months post intervention)
    Title
    Change in HbA1c Measurements after Mindfulness Training
    Description
    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 Frame
    Time 1 (Baseline) and Time 3 (3 months post intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    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 -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Linda Goodfellow
    Organizational Affiliation
    Duquesne University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Fran Cogen, MD
    Organizational Affiliation
    George Washington University School of Medicine and Health Sciences
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Jessica Devido, PhD
    Organizational Affiliation
    Duquesne University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21319908
    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.
    Results Reference
    background
    PubMed Identifier
    1995281
    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.
    Results Reference
    background

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    Mindfulness for Adolescents With Type 1 Diabetes

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