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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:

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I do not have any serious medical conditions like cystic fibrosis or another cancer.

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I have cognitive or developmental issues that may hinder my participation in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3-, and 12- months

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

0 / 3Eligibility criteria met