RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-30
Study Completion:2029-08-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06618027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Type 1 diabetes diagnosed for at least 1 year
  2. * Elevated score on depression measure OR elevated score on anxiety measure
  1. * Cognitive or developmental delays that restrict ability to complete study interventions or assessments
  2. * Teen not fluent in English
  3. * No other serious medical conditions (e.g., cystic fibrosis, cancer)

Contacts and Locations

Study Contact

Eleanor Mackey, PhD
CONTACT
202-476-5307
emackey@childrensnational.org

Principal Investigator

Eleanor Mackey, PhD
PRINCIPAL_INVESTIGATOR
children's national hospital

Study Locations (Sites)

Barbara Davis Center
Aurora, Colorado, 80045
United States
Children's National Hospital
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

  • Eleanor Mackey, PhD, PRINCIPAL_INVESTIGATOR, children's national hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-30
Study Completion Date2029-08-06

Study Record Updates

Study Start Date2025-03-30
Study Completion Date2029-08-06

Terms related to this study

Keywords Provided by Researchers

  • type 1 diabetes
  • adolescents
  • depression
  • anxiety

Additional Relevant MeSH Terms

  • Type 1 Diabetes (T1D)