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Mindfulness-Based Intervention

BREATHE-T1D for Type 1 Diabetes (BREATHE-T1D Trial)

N/A
Waitlist Available
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediate post-intervention follow up, 3 month follow up
Awards & highlights

BREATHE-T1D Trial Summary

This trial is studying a mindfulness-based intervention to help teens with type 1 diabetes manage their condition.

Eligible Conditions
  • Type 1 Diabetes

BREATHE-T1D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediate post-intervention follow up, 3 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediate post-intervention follow up, 3 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interventionist adherence to session manuals
Number of weeks to enroll participants to form one cohort
Percentage enrolled of eligible participants screened per month
+3 more
Secondary outcome measures
Diabetes Eating Problems Survey Revised
Five-Facet Mindfulness Questionnaire
Glycemic control
+6 more

BREATHE-T1D Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BREATHE-T1DExperimental Treatment1 Intervention
BREATHE-T1D is a 6-week group mindfulness program adapted specifically for teens with type 1 diabetes.
Group II: BREATHE-T1D Health EducationPlacebo Group1 Intervention
The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BREATHE-T1D
2022
N/A
~50

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
211 Previous Clinical Trials
208,115 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots remaining in this clinical investigation?

"According to the records posted on clinicaltrials.gov, this medical trial is still seeking participants and was first listed on March 31st 2022 with a most recent update being made April 4th 2022."

Answered by AI

Is the eligibility for this medical trial age-restricted to those over fifty-five years of age?

"This clinical trial seeks individuals between the ages of 12 and 17 to participate."

Answered by AI

What is the ultimate objective of this experiment?

"The principal outcome that will be tracked at regular intervals is the percentage of eligible participants screened each month. Secondary objectives include assessing HbA1c levels (a measure of average glucose concentration over three months, ranging from 4%-14%), an evaluation using the Diabetes Eating Problems Survey Revised (scores range 0-64 with higher scores indicating more disordered eating behaviors), and PROMIS Anxiety Short Form - Adolescent Report T-Scores (totalling between 0-100, with scores above 55 suggesting clinical anxiety)."

Answered by AI

Who meets the criteria to take part in this exploration?

"In order to be accepted into this trial, applicants must have type 1 diabetes and an age between 12 and 17 years old. The project is currently looking for 40 volunteers."

Answered by AI

What is the aggregate involvement of participants in this experiment?

"Affirmative. According to information available on clinicaltrials.gov, this medical research is still actively recruiting participants which began in March 31st 2022 and was last modified April 4th 2022. A total of 40 individuals are expected to be recruited from one site."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
Children's National Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes
Eleanor Mackey 2022. "Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05268393.
~14 spots leftby May 2025
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