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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Children's National Research Institute
Study ID
NCT06618027
Status
Recruiting
Apply to this trial

Conditions

  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
May 15, 2025
Status verified
Jul 2025
Primary completion
Jan 31, 2029
Completion
Aug 6, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Barbara Davis CenterAuroraColorado80045
Todd Alonso, MD
[email protected]
303-724-2323
Todd Alonso, MD (PRINCIPAL_INVESTIGATOR)
Holly O'Donnell, PhD (SUB_INVESTIGATOR)
Bethany Kwan, PhD (SUB_INVESTIGATOR)
Lauren Shomaker, PhD (SUB_INVESTIGATOR)
Laura Pyle, PhD (SUB_INVESTIGATOR)
Children's National HospitalWashington D.C.District of Columbia20010
Eleanor Mackey, PhD
[email protected]
202-476-5307
Randi Streisand, PhD (SUB_INVESTIGATOR)
Molly Basch, PhD (SUB_INVESTIGATOR)
Shideh Majidi, MD (SUB_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
Barbara Davis Center· Aurora, COChildren's National Hospital· Washington D.C., DC

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