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

NCT06618027 | Recruiting DMC

• 2 other identifiers: 00009981R01DK137859-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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)

Keywords

type 1 diabetes; adolescents; depression; anxiety

Outcome Measures

Primary Outcomes (2)

• Glycemic control

  Glycemic control will be measured by at home hemoglobin A1c kits as well as downloads of continuous glucose monitor or blood glucose meter data across a 2 week period, with percent of time in range (70-180) calculated and HbA1c used as an indicator of glycemic control over the prior 3 months.

  Baseline, 3-, and 12-months post intervention

• Depression

  Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a self-report scale on symptoms of depression experienced over the prior two weeks. The possible range of scores is 0-60 with higher scores indicating more severe symptoms of depression.

  Baseline, 3-, and 12-months post intervention

Secondary Outcomes (10)

• Anxiety

  Baseline, 3-, and 12-months post intervention

• Disordered Eating

  Baseline, 3-, and 12-months post intervention

• Mindfulness

  Baseline, 3-, and 12-months post intervention

• Mindfulness

  Baseline, 3-, and 12- months

• Stress

  Baseline, 3-, and 12-months post intervention

Study Arms (2)

Mindfulness-Based Intervention, BREATHE-T1D

EXPERIMENTAL

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.

Behavioral: BREATHE-T1D

Diabetes Education and Support, HealthEd-T1D

PLACEBO COMPARATOR

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.

Behavioral: HealthEd-T1D

Interventions

BREATHE-T1D BEHAVIORAL

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.

Mindfulness-Based Intervention, BREATHE-T1D

HealthEd-T1D BEHAVIORAL

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

Diabetes Education and Support, HealthEd-T1D

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's National Research Institute: lead
• Barbara Davis Center of Childhood Diabetes, University of Co: collaborator
• Colorado State University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Barbara Davis Center

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Children's National Hospital

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

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Eleanor Mackey, PhD

  children's national hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleanor Mackey, PhD

CONTACT

202-476-5307; emackey@childrensnational.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: May 15, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): August 6, 2029
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)