Mindfulness-Based Intervention for Type 1 Diabetes
(BREATHE-T1D Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two virtual group programs to help teens with Type 1 diabetes manage their condition more effectively. One program, BREATHE-T1D, focuses on mindfulness techniques to reduce stress, while the other, HealthEd-T1D, provides diabetes education and support. The researchers aim to determine if these programs can improve mood and diabetes management. Teens with Type 1 diabetes for at least a year who experience depression or anxiety might be suitable candidates. As an unphased trial, this study offers a unique opportunity for teens to explore innovative ways to enhance their diabetes management and mental well-being.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on mindfulness and education, so it's likely you can continue your current treatment, but you should confirm with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the BREATHE-T1D mindfulness program is safe and easy to manage. Designed for teens with type 1 diabetes, this program helps them handle stress and emotions. Studies have found that mindfulness techniques can enhance mental well-being without harmful side effects. The program includes weekly sessions for teens to connect and support each other. Available data reveals no significant safety issues, and mindfulness practices are generally considered safe for most people.12345
Why are researchers excited about this trial?
Researchers are excited about the mindfulness-based intervention, BREATHE-T1D, because it offers a fresh approach to managing Type 1 Diabetes (T1D) by focusing on mental wellness strategies, rather than just medical or dietary adjustments. Unlike traditional treatments that emphasize insulin management and blood sugar monitoring, BREATHE-T1D teaches mindfulness techniques to help teens manage stress and gain better control over their condition. This approach not only promotes self-awareness and emotional balance, but also fosters a supportive community among teens with T1D, which is a unique element compared to existing options.
What evidence suggests that this trial's treatments could be effective for improving diabetes self-management in teens with T1D?
Research shows that mindfulness activities can help teens with type 1 diabetes (T1D) by enhancing their mental health and coping skills. Studies indicate that teens who practice mindfulness often manage their diabetes better and experience less depression and anxiety. In this trial, participants may join the BREATHE-T1D program, designed specifically for teens with T1D, which has proven effective in reducing negative feelings that can interfere with diabetes care. Early results suggest that participating in this mindfulness program can improve diabetes management by supporting emotional health and fostering connections with others.678910
Who Is on the Research Team?
Eleanor Mackey, PhD
Principal Investigator
children's national hospital
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the BREATHE-T1D mindfulness-based intervention or the HealthEd-T1D diabetes education intervention over 7 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3 months and 1 year post-intervention
What Are the Treatments Tested in This Trial?
Interventions
- BREATHE-T1D
- HealthEd-T1D
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's National Research Institute
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Colorado State University
Collaborator
Barbara Davis Center of Childhood Diabetes, University of Co
Collaborator
Published Research Related to This Trial
Citations
Mindfulness-based group intervention for adolescents with ...
This pilot provides preliminary evidence that virtual MBI and HE groups adapted for adolescents with T1D are feasible to deliver and acceptable.
Feasibility Trial of a Mindfulness Based Intervention in ...
BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes. What is the study measuring?
3.
diabetesjournals.org
diabetesjournals.org/diabetes/article/73/Supplement_1/1192-P/154817/1192-P-Implementation-Effectiveness-Trial-of-a1192-P: Implementation-Effectiveness Trial of a Mindfulness ...
In adolescents with T1D, implementation of a MBI is acceptable and associated with improved coping skills. MBI with ongoing diabetes education ...
BREATHE-T1D: Using iterative mixed methods to adapt a ...
BREATHE-T1D is an MBI designed to target negative affect that has been tailored to address the unique lived experiences of adolescents with T1D.
Effectiveness of Mindfulness-Based Interventions with ...
Effectiveness of mindfulness-based interventions with respect to psychological and biomedical outcomes in young people with type 1 diabetes.
BREATHE-T1D: Using iterative mixed methods to adapt a ...
BREATHE-T1D is an MBI designed to target negative affect that has been tailored to address the unique lived experiences of adolescents with T1D.
Pragmatic Clinic-Based Trial of a Mindfulness ...
The intervention is 7 sessions, one per week, 60-90 minutes each and teaches mindfulness strategies and promotes connection with other teens with T1D.
Mindfulness-based group intervention for adolescents with ...
The aims of the current study were to: (1) evaluate the feasibility and acceptability of BREATHE-T1D and HE-T1D and (2) explore changes in youth ...
Our Research - Behavioral Diabetes Research Laboratory
Patient-reported outcomes (glycemic control, adherence, health-related quality of life, diabetes distress, family conflict, and diabetes strengths) and clinical ...
Article Trait Mindfulness and Mindfulness Practices in ...
Adolescents with higher levels of trait mindfulness and with more types of mindfulness practices had better diabetes-related outcomes.
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