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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 17
Healthy Volunteers: f
View:

• Type 1 diabetes diagnosed for at least 1 year

• Elevated score on depression measure OR elevated score on anxiety measure

Locations
United States
Colorado
Barbara Davis Center
NOT_YET_RECRUITING
Aurora
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Contact Information
Primary
Eleanor Mackey, PhD
emackey@childrensnational.org
202-476-5307
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2029-08-06
Participants
Target number of participants: 200
Treatments
Experimental: Mindfulness-Based Intervention, BREATHE-T1D
Learning to BREATHE, an existing group-based mindfulness intervention, was adapted in a prior trial, using the input of teens with T1D, to utilize mindfulness as a strategy for supporting the management of T1D. The intervention is 7 sessions, one per week, 60-90 minutes each and teaches mindfulness strategies and promotes connection with other teens with T1D.
Placebo_comparator: Diabetes Education and Support, HealthEd-T1D
HealthEd-T1D was designed using input of teens with T1D to be a 6 session, 60 minutes once per week program to promote knowledge and empowerment in diabetes management as well as to encourage connection with other teens with T1D.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Barbara Davis Center of Childhood Diabetes, University of Co, Colorado State University
Leads: Children's National Research Institute

This content was sourced from clinicaltrials.gov