Mindfulness for Adolescents With Type 1 Diabetes

NCT03942471 | Completed

• 1 other identifier: 2015/10/14
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Intervention Mindfulness Based Stress Reduction

OTHER

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

Behavioral: Mindfulness Based Stress Reduction

Control Group

NO INTERVENTION

Wait Group - received no mindfulness teaching

Interventions

Mindfulness Based Stress Reduction BEHAVIORAL

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.

Also known as: MBSR

Intervention Mindfulness Based Stress Reduction

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents between the ages of 12 - 19
• Diagnosis of Type 1 Diabetes
• Fluent in English
• No diagnosed cognitive impairments
• th grade education completion
• Access to a Computer
• Access to the internet

Sponsors & Collaborators

• Duquesne University: lead

Related 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.

  PMID: 21319908 BACKGROUND

• 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.

  PMID: 1995281 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Linda Goodfellow

  Duquesne University

  STUDY CHAIR

• Fran Cogen, MD

  George Washington University School of Medicine and Health Sciences

  STUDY DIRECTOR

• Jessica Devido, PhD

  Duquesne University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: between and within group repeated measures design

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: May 8, 2019
• Study Start: October 14, 2015
• Primary Completion: October 1, 2018
• Study Completion: January 5, 2019
• Last Updated: May 8, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share