Mindfulness-Based Intervention for Type 1 Diabetes

(BREATHE-T1D Trial)

Recruiting at 2 trial locations

Overseen By Randi Streisand, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Cognitive delays, Non-English, others

Compensation: Varies

Number of Visits: 10

Duration: 7 weeks

200 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Who Is on the Research Team?

Eleanor Mackey, PhD

Principal Investigator

children&#39;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

Elevated score on depression measure OR elevated score on anxiety measure

I have been diagnosed with Type 1 diabetes for over a year.

Exclusion Criteria

Teen not fluent in English

I do not have any serious medical conditions like cystic fibrosis or another cancer.

I have cognitive or developmental issues that may hinder my participation in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the BREATHE-T1D mindfulness-based intervention or the HealthEd-T1D diabetes education intervention over 7 weeks

7 weeks

7 virtual group sessions, 60-90 minutes each

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 months and 1 year post-intervention

12 months

Assessments at 3 months and 12 months 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?

Group I: Mindfulness-Based Intervention, BREATHE-T1D Experimental Treatment 1 Intervention

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.

Group II: Diabetes Education and Support, HealthEd-T1D Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Colorado State University

Collaborator

Trials

138

Recruited

38,200+

Barbara Davis Center of Childhood Diabetes, University of Co

Collaborator

Trials

1

Recruited

200+

Published Research Related to This Trial

Mindfulness-Based Stress Reduction (MBSR) was found to be highly acceptable and feasible for a small group of 10 older adolescents and young adults with poorly controlled type 1 diabetes, showing high satisfaction rates among participants.

Preliminary results suggest that MBSR may help reduce stress and improve blood glucose levels, indicating its potential as a supportive intervention for diabetes management, although further research in larger trials is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Mindfulness-Based Stress Reduction for Older Adolescents and Young Adults with Poorly Controlled Type 1 Diabetes. Ellis, DA., Carcone, A., Slatcher, R., et al.[2022]

Mindfulness interventions have been found to be effective and acceptable for improving psychosocial and glycemic outcomes in adolescents and young adults with type 1 diabetes (T1D) and prediabetes, based on a review of 10 studies.

The review highlighted the need for further exploration of mobile health technology to enhance the feasibility of delivering mindfulness interventions, as no studies specifically addressed mindfulness in adolescents and young adults with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness in adolescents and young adults with diabetes: An integrative review. Koerner, R., Rechenberg, K.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39212647/

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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05268393

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-a

1192-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 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424001344

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.

5. mdpi.com mdpi.com/2227-9032/12/18/1876

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.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38692428/

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.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06618027

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.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11493139/

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 ...

9. childrensnational.org childrensnational.org/research/labs/diabetes/research

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 ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0891524521001851

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.