Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes (BREATHE-T1D)

January 16, 2025 updated by: Eleanor Mackey, Children's National Research Institute

Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1

Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood. The involved treatment regimen, including daily insulin administration/pump management, frequent blood glucose checks, and careful track-ing of food intake, places a high-stress burden on patients and their families. Adolescence is a particularly risky time for T1D management given a marked decline in treatment adherence and glycemic control. Over 80% of adolescents with T1D have poor glycemic control (A1c >7.5%), and one significant risk factor is the increase in negative affectivity, including depression and anxiety symptoms, that distinguish adolescents with T1D. Elevated depression and anxiety symptoms affect 40% of teens with T1D. Preliminary data support the notion that negative affectivity contributes to diminished treatment adherence and worsening of glycemic control, partially through the effects of negative affectivity on stress-related behavior such as maladaptive eating behavior (e.g., dietary restriction, uncontrolled eating patterns, and insulin omission for weight control). There is no gold-standard approach to address the poor glycemic control seen in adolescents with T1D. The creation of novel, targeted interventions, tailored for the developmental needs of adolescents with T1D and the particular burdens of coping with their chronic illness, are needed. Mindfulness-based interventions delivered to adolescents without T1D, including the team's preliminary work in teens with depression and weight-related disorders, have shown promise in treating negative affectivity, maladaptive eating behavior, and health outcomes. A mindfulness-based approach may be well-suited for adolescents with T1D, but given that the mechanisms of association among negative affectivity, stress-related behavior, and self-care are unique to individuals with T1D, interventions must be specifically tailored for this population. The goal of this study is to, therefore, adapt an existing 6-session mindfulness-based intervention, Learning to BREATHE, for use with adolescents with T1D (BREATHE-T1D). The first specific aim of the study is to adapt BREATHE for adolescents with T1D and to adapt a relevant and credible health education comparison curriculum (HealthEd-T1D). The second aim is to carry out a 2-way pilot randomized controlled trial to evaluate the feasibility and acceptability of BREATHE-T1D and HealthEd-T1D. The result of the current study will be a feasible and acceptable mindfulness intervention and comparison curriculum that can be evaluated in an efficacy trial. The multidisciplinary study team contributes complementary areas of expertise in adolescents with T1D, behavioral intervention development, negative affectivity and maladaptive eating behavior, adolescent mindfulness-based intervention, qualitative data analysis, and delivery of behavioral health interventions via telehealth. The study's innovative approach will enable the investigators to establish a feasible/acceptable intervention tailored for adolescents with T1D, leading to a future proposal for a full-scale efficacy trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age 12-17y
  • T1D, with at least 1-year duration of illness
  • negative affectivity, defined as clinically elevated scores (T-score >55 indicating at least mild depression/anxiety symptoms on either the PROMIS short form-depression and/or anxiety scales)
  • A1c >7.5%
  • English-speaking

Exclusion Criteria:

  • no cognitive or developmental delays which would interfere with their ability to participate in the study
  • are able and willing to complete questionnaires and intervention via the internet
  • do not have severe depression or active or recent (within the past two months) suicidal ideation
  • have no other serious medical conditions (e.g., cystic fibrosis, cancer).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BREATHE-T1D
BREATHE-T1D is a 6-week group mindfulness program adapted specifically for teens with type 1 diabetes.
Behavioral: BREATHE-T1D
BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Placebo Comparator: BREATHE-T1D Health Education
The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive.
Behavioral: BREATHE-T1D
BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Enrolled of Eligible Participants Screened
Time Frame: During screening (10 months total)
The percentage is calculated first by identifying the number of enrolled participants divided by eligible participants. 42 total patients were eligible once screened across the 10 month enrollment period. 42 total then enrolled in the study.
During screening (10 months total)
Number of Weeks to Enroll Participants to Form One Cohort
Time Frame: During screening (10 months)
Number of weeks to enroll 10 participants to be randomized 5 per group
During screening (10 months)
Percentage of Participants With Data Collected
Time Frame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Number of participants with data at each time point.
Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Percentage of Attended Sessions
Time Frame: Immediate post-intervention follow-up (2-3 months post baseline)
Number of intervention sessions (calculated by multiplying number of expected sessions by number of participants for total possible sessions held) attended divided by total number of intervention sessions expected per group.
Immediate post-intervention follow-up (2-3 months post baseline)
Satisfaction With Intervention Program
Time Frame: Immediate post-intervention follow-up (2-3 months post-baseline)
Satisfaction report by participants
Immediate post-intervention follow-up (2-3 months post-baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mindful Attention Awareness Scale
Time Frame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Assessed via teen report. Scores are calculated as an average score of all items with a range of 1 (minimum) to 6 (maximum) with higher scores indicating more mindful attention in daily life.
Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Five-Facet Mindfulness Questionnaire
Time Frame: Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post-baseline)
Assessed via teen report. Scores are calculated as a total score across all items in the scale with a range of 1 (minimum) to 5 (maximum) and total scores presented are a sum of the sub scale (observing, describing, acting with awareness, nonjudging, and non-reactivity) with possible scores ranging from 5-25 with higher scores indicating more mindfulness.
Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post-baseline)
PROMIS Depression Short Form - Adolescent Report
Time Frame: Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Scores are calculated as t-scores with higher scores indicating more depressive symptoms. T-scores (range 0-100) over 55 indicate clinically significant depressive symptoms. Interpretation of t-scores is based on a mean of 50 and standard deviation of 10.
Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
PROMIS Anxiety Short Form - Adolescent Report
Time Frame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Scores are calculated as t-scores (range 0-100) with higher scores indicating more anxiety symptoms.T-scores over 55 indicate clinically significant anxiety symptoms. Interpretation of t-scores is based on a mean of 50 and standard deviation of 10.
Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Diabetes Eating Problems Survey Revised
Time Frame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Teen report with higher scores indicating more disordered eating behaviors with scores over 25 indicating clinically significant problems. Total scores range from 0 to 64 with higher scores indicating more disordered eating behaviors.
Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
UPPS-P Negative Urgency Subscale
Time Frame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Teen report on the UPPS-P Negative Urgency subscale with higher scores indicating more likelihood to act impulsively when experiencing a negative mood. Scores are calculated with an average which can range from 1(minimum) to 4 (maximum).
Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Self-Care Inventory
Time Frame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Teen report on the Self-Care Inventory, a measure of diabetes management with higher scores indicating better self-care for diabetes. Average scores range from 1 (minimum) to 5 (maximum).
Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Problem Areas in Diabetes - Teen
Time Frame: Baseline, immediate post intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
The Problem Areas in Diabetes-Teen (PAID-T) is a 14-item measure of diabetes distress in adolescents with type 1 diabetes. Adolescents are asked how often each diabetes-related problem applied to them in the past month, on a six-point Likert scale (ranging from not a problem to serious problem), with scores reflecting a total across 14 items and higher scores indicating greater severity and a clinical cutoff of >44. Scores can range from 14-84.
Baseline, immediate post intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Glycemic Control
Time Frame: Baseline, immediate post intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
HbA1c is a measure of an average blood glucose level over the past 3 months and will be abstracted from the medical record as it is assessed at each regular diabetes clinic visit. HbA1c typically ranges from 4% to >14%.
Baseline, immediate post intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
Interventionist Adherence to Session Manuals
Time Frame: Week 6 of intervention
Supervisors listened to recordings of sessions for both programs and completed checklists assessing for the number of expected intervention components included in the sessions. Therefore, values reflect the percentage of expected intervention components included across all program sessions calculated at the end of the intervention period (week 6) for each group cohort.
Week 6 of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's National Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15464
  • R34AT011035 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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