Clinical Trial

Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth With Type 1 Diabetes

Study acronym: BREATHE-T1D
Recruiting
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Summary
Type 1 diabetes (T1D) is a common chronic illness among children requiring a high degree of self-management for good glycemic control. Adolescents are at risk for poor disease management and health outcomes due to a number of factors, including high rates of depression, anxiety, and stress. Accessing support for these challenges can be a barrier to care, so the current study, BRinging Empowerment and Attention to Teen HEalth-T1D, evaluates the efficacy of a virtual, group-based mindfulness based intervention and a virtual group-based diabetes education intervention on improving symptoms of depression and anxiety, and diabetes self management in teens with T1D. The study also aims to study how these interventions might be implemented in diabetes clinic settings.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-09-25; most recent amendment 2025-07-07.
Status change: Not Yet Recruiting → Recruiting 2025-06-30
Trial Details
NCT Number NCT06618027
Lead Sponsor Children's National Research Institute
Collaborators: Barbara Davis Center of Childhood Diabetes, University of Co, Colorado State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Type 1 Diabetes (T1D)
Enrollment 200 participants
Start Date 2025-05-15
Primary Completion 2029-01-31 (estimated)
Study Completion 2029-08-06 (estimated)
Updated on ClinicalTrials.gov 2025-07-08