Recruiting

Mindfulness & Education

Sponsor:

Children's National Research Institute

Code:

NCT06618027

Conditions

Type 1 Diabetes (T1D)

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

BREATHE-T1D

HealthEd-T1D

Study Details

Brief 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)

Study ID

NCT06618027

Start date

May 15, 2025

Status verified date

Jul, 2025

Completion date

Aug 6, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Type 1 diabetes diagnosed for at least 1 year
  • Elevated score on depression measure OR elevated score on anxiety measure

Exclusion Criteria:

  • 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)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

HealthEd-T1D

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

Primary outcome measure

  • Glycemic control [ Time Frame: Baseline, 3-, and 12-months post intervention ]
  • Depression [ Time Frame: Baseline, 3-, and 12-months post intervention ]

Central Contacts and Locations

Central contacts

Eleanor Mackey, PhD

202-476-5307emackey@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Eleanor Mackey, PhD

202-476-5307breathet1d@childrensnational.org

More Information

Sponsor

Children's National Research Institute

Last update posted

Jul 8, 2025

Last verified

Jul, 2025

Keywords

  • type 1 diabetes
  • adolescents
  • depression
  • anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2025-07-08.