BREATHE-T1D for Type 1 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's National Hospital, Washington, United StatesType 1 DiabetesBREATHE-T1D - Behavioral
Eligibility
12 - 17
All Sexes
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Study Summary

This trial is studying a mindfulness-based intervention to help teens with type 1 diabetes manage their condition.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Study Objectives

6 Primary · 9 Secondary · Reporting Duration: Baseline, Immediate post-intervention follow up, 3 month follow up

Baseline
Number of weeks to enroll participants to form one cohort
Percentage enrolled of eligible participants screened per month
Month 3
Diabetes Eating Problems Survey Revised
Five-Facet Mindfulness Questionnaire
Glycemic control
Mindful Attention Awareness Scale
PROMIS Anxiety Short Form - Adolescent Report
PROMIS Depression Short Form - Adolescent Report
Percentage of missing assessment data
Problem Areas in Diabetes - Teen
Self-Care Inventory
UPPS-P Negative Urgency subscale
Immediate post-intervention follow-up
Interventionist adherence to session manuals
Percentage of missed sessions per participant
Satisfaction with intervention program

Trial Safety

Trial Design

2 Treatment Groups

BREATHE-T1D
1 of 2
BREATHE-T1D Health Education
1 of 2

Experimental Treatment

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: BREATHE-T1D · Has Placebo Group · N/A

BREATHE-T1D
Behavioral
Experimental Group · 1 Intervention: BREATHE-T1D · Intervention Types: Behavioral
BREATHE-T1D Health Education
Behavioral
PlaceboComparator Group · 1 Intervention: BREATHE-T1D · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, immediate post-intervention follow up, 3 month follow up

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
194 Previous Clinical Trials
206,347 Total Patients Enrolled

Eligibility Criteria

Age 12 - 17 · All Participants · 5 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Maryland100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Children's National Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Are there any available slots remaining in this clinical investigation?

"According to the records posted on clinicaltrials.gov, this medical trial is still seeking participants and was first listed on March 31st 2022 with a most recent update being made April 4th 2022." - Anonymous Online Contributor

Unverified Answer

Is the eligibility for this medical trial age-restricted to those over fifty-five years of age?

"This clinical trial seeks individuals between the ages of 12 and 17 to participate." - Anonymous Online Contributor

Unverified Answer

What is the ultimate objective of this experiment?

"The principal outcome that will be tracked at regular intervals is the percentage of eligible participants screened each month. Secondary objectives include assessing HbA1c levels (a measure of average glucose concentration over three months, ranging from 4%-14%), an evaluation using the Diabetes Eating Problems Survey Revised (scores range 0-64 with higher scores indicating more disordered eating behaviors), and PROMIS Anxiety Short Form - Adolescent Report T-Scores (totalling between 0-100, with scores above 55 suggesting clinical anxiety)." - Anonymous Online Contributor

Unverified Answer

Who meets the criteria to take part in this exploration?

"In order to be accepted into this trial, applicants must have type 1 diabetes and an age between 12 and 17 years old. The project is currently looking for 40 volunteers." - Anonymous Online Contributor

Unverified Answer

What is the aggregate involvement of participants in this experiment?

"Affirmative. According to information available on clinicaltrials.gov, this medical research is still actively recruiting participants which began in March 31st 2022 and was last modified April 4th 2022. A total of 40 individuals are expected to be recruited from one site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.