About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Type 1 diabetes diagnosed for at least 1 year
Elevated score on depression measure OR elevated score on anxiety measure
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
BREATHE-T1D
BehavioralBREATHE-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
BehavioralHealthEd-T1D is a 6 week, virtual, group based diabetes education group.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Anxiety
Screen for Child Anxiety Related Disorders (SCARED). The SCARED is a self report measure with higher scores indicative of an anxiety disorder.
Disordered Eating
Diabetes Eating Problem Survey - Revised (DEPS-R) is a self-report measure that asks about disordered eating behaviors, including those specific to individuals with diabetes. Higher scores indicate more disordered eating symptoms.
Mindfulness
Mindful Attention Awareness Scale (MAAS) is a self-report measure assessing how mindful people are in their day to day lives. Higher scores indicate higher levels of dispositional mindfulness.
Mindfulness
The Five-Factor Mindfulness Questionnaire is a self-report measure that evaluates elements of mindfulness, including the following aspects: observing, describing, acting with awareness, nonreactivity, and non-judgement. Higher scores indicate a higher level of mindfulness.
Sponsors and contacts
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Children's National Research Institute
Lead sponsor
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