ClinicalTrialsFinder
RecruitingNot ApplicableNCT06618027

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

Sponsor

Children's National Research Institute

Enrollment

200 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes (T1D)

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

Min Age: 13 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a mindfulness-based therapy program for teenagers with Type 1 diabetes who are experiencing depression or anxiety. Managing a chronic condition like diabetes is stressful, and this study aims to find out if mindfulness techniques can help improve emotional well-being alongside diabetes management. **You may be eligible if...** - You are a teenager with Type 1 diabetes (diagnosed at least 1 year ago) - You are showing elevated symptoms of depression or anxiety on a screening measure - You can participate in the study interventions and complete assessments **You may NOT be eligible if...** - You have a cognitive or developmental condition that would make completing the study difficult - You are not fluent in English - You have another serious medical condition (such as cystic fibrosis or cancer) in addition to diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALBREATHE-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.

BEHAVIORALHealthEd-T1D

HealthEd-T1D is a 6 week, virtual, group based diabetes education group.

Locations(2)

Barbara Davis Center

Aurora, Colorado, United States

Children's National Hospital

Washington D.C., District of Columbia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06618027

Related Trials

Kidney Precision Medicine Project

NCT0433470713 locations

Capillary OGTT Study

NCT068150814 locations

A Study of GNTI-122 in Adults Recently Diagnosed With T1D

NCT0691935410 locations

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

NCT070111472 locations

Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.

NCT074705931 location