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NCT06618027: BREATHE-T1D

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

Recruiting now NA Last updated 8 July 2025
What this trial tests

NA trial testing BREATHE-T1D in Type 1 Diabetes (T1D) in 200 participants. Currently enrolling.

Timeline
15 May 2025
Primary endpoint
31 January 2029
6 August 2029

Quick facts

Lead sponsorChildren's National Research Institute
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment200
Start date15 May 2025
Primary completion31 January 2029
Estimated completion6 August 2029
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's National Research Institute

Who can join

Adults 13 to 17, any sex, with Type 1 Diabetes (T1D). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of BREATHE-T1D

Trials testing the same drug.

Other recruiting trials for Type 1 Diabetes (T1D)

Currently open trials in the same condition.

Other Children's National Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06618027.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing