Mindfulness-Based Intervention for Type 1 Diabetes

(BREATHE-T1D Trial)

Recruiting at 1 trial location

Overseen By Eleanor Mackey, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Children's National Research Institute

Prior Safety Data

Trial Summary

What is the purpose of 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.

Research Team

Eleanor Mackey, PhD

Principal Investigator

children&#39;s national hospital

Eligibility Criteria

This trial is for teens with Type 1 Diabetes who may be struggling with depression, anxiety, or stress. It's designed to help them manage their mood and diabetes better. Participants should have regular access to the internet as interventions are virtual.

Inclusion Criteria

Elevated score on depression measure OR elevated score on anxiety measure

I have been diagnosed with Type 1 diabetes for over a year.

Exclusion Criteria

Teen not fluent in English

I do not have any serious medical conditions like cystic fibrosis or another cancer.

I have cognitive or developmental issues that may hinder my participation in the study.

Treatment Details

Interventions

• BREATHE-T1D (Behavioral Intervention)
• HealthEd-T1D (Behavioral Intervention)

Trial Overview The study tests two virtual group-based programs: BREATHE-T1D focuses on mindfulness to improve mental health and diabetes management; HealthEd-T1D provides education about diabetes. The goal is to see which helps more with mood concerns and self-care in youths.

Participant Groups

Group I: Mindfulness-Based Intervention, BREATHE-T1D Experimental Treatment 1 Intervention

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.

Group II: Diabetes Education and Support, HealthEd-T1D Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Colorado State University

Collaborator

Trials

138

Recruited

38,200+

Barbara Davis Center of Childhood Diabetes, University of Co

Collaborator

Trials

1

Recruited

200+