Virtual group mindfulness or diabetes education for teens with type 1 diabetes and mood symptoms
Official title: Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth With Type 1 Diabetes
Run by Children's National Research Institute · NCT06618027 · Data updated 2026-11-12
This trial tests whether a virtual group mindfulness program or a virtual group diabetes-education program helps teens with type 1 diabetes who have symptoms of depression or anxiety.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 13 Years to 17 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Status | Recruiting |
| Started | May 15, 2025 |
| Main results expected | January 31, 2029 |
| Study ends | August 6, 2029 |
| Registry record updated | July 8, 2025 |
| Trial ID | NCT06618027 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Teens with type 1 diabetes diagnosed for at least one year who have elevated symptoms of depression or anxiety, are fluent in English, and do not have cognitive/developmental delays or other serious medical conditions are ideal candidates.
✕Probably not a fit
Patients without elevated mood symptoms, non–English speakers, those with significant cognitive/developmental impairments, or those with other serious medical conditions are unlikely to benefit or be eligible for this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pragmatic clinic-based trial enrolls adolescents with type 1 diabetes and elevated depression or anxiety symptoms and delivers two different virtual group interventions: a mindfulness-based program (BREATHE-T1D) and a diabetes-focused education program (HealthEd-T1D). Participants are recruited through pediatric diabetes clinics at Children's National and the Barbara Davis Center and take part in group sessions delivered online. Primary outcomes include changes in depression and anxiety symptoms and diabetes self-management behaviors, with attention to implementation in routine clinic settings. The interventions were adapted from a pilot program using stakeholder input and are compared to determine which approach better supports mood and diabetes care in teens.
Why it matters
Potential benefit: If successful, the interventions could reduce depression and anxiety symptoms and improve diabetes self-management in adolescents, which may help with better glycemic control and longer-term health.
How similar studies have gone: Prior pilot work adapting the BREATHE-T1D mindfulness program demonstrated feasibility and initial promise, and mindfulness interventions for adolescent mood have shown mixed but often positive results, although diabetes-specific evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Children's National Hospital
Washington D.C., District of Columbia, United States Recruiting -
Barbara Davis Center
Aurora, Colorado, United States Not yet recruiting
Study contacts
- Principal investigator: Eleanor Mackey, PhD — children's national hospital
- Study coordinator: Eleanor Mackey, PhD
- Email: emackey@childrensnational.org
- Phone: 202-476-5307
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.