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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorChildren's National Research Institute

About this trial

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

Qualifiers

Type 1 diabetes diagnosed for at least 1 year

Elevated score on depression measure OR elevated score on anxiety measure

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • BREATHE-T1D
  • HealthEd-T1D

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's National Research Institute

Lead sponsor

Barbara Davis Center of Childhood Diabetes, University of Co

Collaborator

Colorado State University

Collaborator

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

Collaborator