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Type 1 Diabetes MellitusNCT03942471

Mindfulness for Adolescents With Type 1 Diabetes

A study testing Mindfulness Based Stress Reduction in people with Type 1 Diabetes Mellitus, run by Duquesne University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 to 19 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Mindfulness Based Stress Reduction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
No sites listed yet
Study dates
14 Oct 2015to 5 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Access to the internet
  • Exclusion Criteria: under 12, over 19 - no access to a computer/internet
  • -

Who cannot join

None listed.

About this study

Official title: 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.

Read the 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.

Being tested
Mindfulness Based Stress Reduction
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Based Stress ReductionBehavioural

    Also called MBSR

    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.

Study groups in NCT03942471
Study groupRoleWhat they receive
Intervention Mindfulness Based Stress ReductionOtherSix Modules each delivering an important principle of Mindfulness Based Stress Reduction
Receives: Behavioral: Mindfulness Based Stress Reduction
Control GroupNo interventionWait Group - received no mindfulness teaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Time 1 (Baseline), Time 2 (6 weeks post intervention) and Time 3 (3 months post intervention)

  2. 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

    Measured: Time 1 (Baseline), Time 2 (6 weeks post intervention) and Time 3 (3 months post intervention)

  3. 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.

    Measured: Time 1 (Baseline) and Time 3 (3 months post intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2019
  2. Study start14 Oct 2015
  3. Primary completion1 Oct 2018
  4. Study completion5 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
between and within group repeated measures design
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03942471
Sponsor's protocol ID
2015/10/14
Status last verified
May 2019
First submitted
29 Mar 2019
Last updated
8 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 21319908

  • 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.

    PubMed 1995281

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Stress Reduction in people with Type 1 Diabetes Mellitus, run by Duquesne University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03942471, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.

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