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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorChildren's National Research Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Mindfulness-Based Intervention, BREATHE-T1DExperimental treatment 1 intervention
Group B: Diabetes Education and Support, HealthEd-T1DPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 3-, and 12-months post intervention
2

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.

Time frame
Baseline, 3-, and 12-months post intervention

Secondary outcomes

1

Anxiety

Screen for Child Anxiety Related Disorders (SCARED). The SCARED is a self report measure with higher scores indicative of an anxiety disorder.

Time frame
Baseline, 3-, and 12-months post intervention
2

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.

Time frame
Baseline, 3-, and 12-months post intervention
3

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.

Time frame
Baseline, 3-, and 12-months post intervention
4

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.

Time frame
Baseline, 3-, and 12- months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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