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Behavioral Intervention

Mindfulness-Based Intervention for Type 1 Diabetes (BREATHE-T1D Trial)

Phase 2 & 3
Waitlist Available
Led By Eleanor Mackey, PhD
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
Type 1 diabetes diagnosed for at least 1 year
Be younger than 18 years old
Must not have
No other serious medical conditions (e.g., cystic fibrosis, cancer)
Cognitive or developmental delays that restrict ability to complete study interventions or assessments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3-, and 12- months

Summary

"This trial evaluates two virtual group interventions for teenagers with type 1 diabetes to improve their mental health and diabetes self-management. The study aims to see how these interventions can be used in diabetes clinics."

Who is the study for?
This trial is for teens with Type 1 Diabetes who may be struggling with depression, anxiety, or stress. It's designed to help them manage their mood and diabetes better. Participants should have regular access to the internet as interventions are virtual.
What is being tested?
The study tests two virtual group-based programs: BREATHE-T1D focuses on mindfulness to improve mental health and diabetes management; HealthEd-T1D provides education about diabetes. The goal is to see which helps more with mood concerns and self-care in youths.
What are the potential side effects?
Since the interventions involve mindfulness practices and educational content rather than medications, there are no typical drug side effects. However, participants might experience emotional discomfort while discussing personal issues during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Type 1 diabetes for over a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any serious medical conditions like cystic fibrosis or another cancer.
Select...
I have cognitive or developmental issues that may hinder my participation in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3-, and 12- months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3-, and 12- months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Depression
Glycemic control
Secondary study objectives
Anxiety
Avoidant Coping
Diabetes Distress
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mindfulness-Based Intervention, BREATHE-T1DExperimental Treatment1 Intervention
Learning to BREATHE, an existing group-based mindfulness intervention, was adapted in a prior trial, using the input of teens with T1D, to utilize mindfulness as a strategy for supporting the management of T1D. The intervention is 7 sessions, one per week, 60-90 minutes each and teaches mindfulness strategies and promotes connection with other teens with T1D.
Group II: Diabetes Education and Support, HealthEd-T1DPlacebo Group1 Intervention
HealthEd-T1D was designed using input of teens with T1D to be a 6 session, 60 minutes once per week program to promote knowledge and empowerment in diabetes management as well as to encourage connection with other teens with T1D.
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
220 Previous Clinical Trials
257,970 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,432 Previous Clinical Trials
4,323,041 Total Patients Enrolled
Colorado State UniversityOTHER
132 Previous Clinical Trials
38,227 Total Patients Enrolled
~133 spots leftby Jan 2029
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