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

NCT06618027 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-08

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes (T1D)

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.

Sponsors & Collaborators

  • Barbara Davis Center of Childhood Diabetes, University of Co

    collaborator UNKNOWN

  • Colorado State University

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • Eleanor Mackey, PhD · children's national hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2029-01-31
Completion
2029-08-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06618027 on ClinicalTrials.gov