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NCT06618027

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

Recruiting
NAAges 13–17InterventionalTreatment
Children's National Research Institute
~200 participants
Updated 2025-07-08 on ClinicalTrials.gov
What's tested:BREATHE-T1DHealthEd-T1D

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glycemic control
Measured over Baseline, 3-, and 12-months post intervention
+1 more outcome measured

Conditions

Type 1 Diabetes (T1D)

Where it's being run

2 sites across 2 states
Colorado1
District of Columbia1

Study leadership

  • Eleanor Mackey, PhD · PRINCIPAL_INVESTIGATOR · children's national hospital

Who to contact

Eleanor Mackey, PhD
[email protected]
202-476-5307
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Type 1 diabetes diagnosed for at least 1 year
Elevated score on depression measure OR elevated score on anxiety measure

Exclusion

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)

What this trial measures

  • Glycemic controlBaseline, 3-, and 12-months post intervention

    Glycemic control will be measured by at home hemoglobin A1c kits as well as downloads of continuous glucose monitor or blood glucose meter data across a 2 week period, with percent of time in range (70-180) calculated and HbA1c used as an indicator of glycemic control over the prior 3 months.

  • DepressionBaseline, 3-, and 12-months post intervention

    Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a self-report scale on symptoms of depression experienced over the prior two weeks. The possible range of scores is 0-60 with higher scores indicating more severe symptoms of depression.