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Recruiting NCT06618027

NCT06618027 Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth With Type 1 Diabetes

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Clinical Trial Summary
NCT ID NCT06618027
Status Recruiting
Phase —
Sponsor Children's National Research Institute
Condition Type 1 Diabetes (T1D)
Study Type INTERVENTIONAL
Enrollment 200 participants
Start Date 2025-05-15
Primary Completion 2029-01-31

Eligibility & Interventions

Sex All sexes
Min Age 13 Years
Max Age 17 Years
Study Type INTERVENTIONAL
Interventions
BREATHE-T1DHealthEd-T1D

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 200 participants in total. It began in 2025-05-15 with a primary completion date of 2029-01-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Type 1 diabetes diagnosed for at least 1 year * Elevated score on depression measure OR elevated score on anxiety measure Exclusion Criteria: * Cognitive or developmental delays that restrict ability to complete study interventions or assessments * Teen not fluent in English * No other serious medical conditions (e.g., cystic fibrosis, cancer)

Contact & Investigator

Central Contact

Eleanor Mackey, PhD

✉ emackey@childrensnational.org

📞 202-476-5307

Principal Investigator

Eleanor Mackey, PhD

PRINCIPAL INVESTIGATOR

children's national hospital

Frequently Asked Questions

Who can join the NCT06618027 clinical trial?

This trial is open to participants of all sexes, aged 13 Years or older, up to 17 Years, studying Type 1 Diabetes (T1D). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06618027 currently recruiting?

Yes, NCT06618027 is actively recruiting participants. Contact the research team at emackey@childrensnational.org for enrollment information.

Where is the NCT06618027 trial being conducted?

This trial is being conducted at Aurora, United States, Washington D.C., United States.

Who is sponsoring the NCT06618027 clinical trial?

NCT06618027 is sponsored by Children's National Research Institute. The principal investigator is Eleanor Mackey, PhD at children's national hospital. The trial plans to enroll 200 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: November 2026  ·  Data Methodology