NCT06618027 · Children's National Research Institute
Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth With Type 1 Diabetes
(BREATHE-T1D)
What this study is about
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.
View original scientific 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.
Interventions
BEHAVIORAL
BREATHE-T1D
BREATHE-T1D was adapted from Learning to BREATHE, a group mindfulness-based intervention for teens. It teaches mindfulness strategies adapted to be specific and relatable to, teens with T1D to improves symptoms of depression and anxiety as well as diabetes self-management.
BEHAVIORAL
HealthEd-T1D
HealthEd-T1D is a 6 week, virtual, group based diabetes education group.
Primary outcome measures
Glycemic control
Time frame: Baseline, 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.
Depression
Time frame: Baseline, 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Aurora, Colorado
- Washington D.C., District of Columbia
Collaborators
Barbara Davis Center of Childhood Diabetes, University of Co, Colorado State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2025 · Source of record for eligibility and locations