Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth with Type 1 Diabetes - Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood. The involved treatment regimen, including daily insulin administration/pump management, frequent blood glucose checks, and careful tracking of food intake, places a high stress burden on patients and their families. Adolescence is a particularly risky time for T1D management given a marked decline in treatment adherence and difficulty achieving glycemic goals. Over 80% of adolescents with T1D have glycemic control that does not reach target levels (A1c >7.0%), and one significant risk factor is the increase in negative affectivity, i.e. depression and anxiety symptoms, that distinguish adolescents with T1D. Elevated depression and anxiety symptoms affect 40% of teens with T1D. Our preliminary data support the notion that depression and anxiety symptoms contribute to diminished treatment adherence and worsening of glycemia, partially through the effects of negative affectivity on stress-related behavior such as maladaptive eating behavior (e.g., dietary restriction, uncontrolled eating patterns, and insulin omission for weight control). The use of novel, targeted interventions, tailored for the developmental needs of adolescents with T1D and the particular burdens of coping with their chronic illness, that are translatable and able to be disseminated into clinics are needed. Our pilot work adapted, with the collaboration of stakeholders (i.e., diabetes providers and adolescent patients), a 7-week, group mindfulness-based intervention based on Learning to BREATHE, BREATHE-T1D, and a health education comparison condition, HealthEd-T1D, for adolescents with T1D. This pilot study demonstrated the feasibility and acceptability of participation in both groups with the ultimate goal of improving glycemic control via improvements to mood and therefore less disordered eating, avoidant coping, less impulsivity, and better self-care. The primary goal of the current proposal, therefore, is to conduct a full-scale efficacy trial of BREATHE-T1D as compared to HealthEd-T1D across two sites, Children’s National Hospital in Washington, DC and the University of Colorado in Denver. The study will be a pragmatic, hybrid type 1 implementation/efficacy clinical trial with another primary aim to conduct a pilot feasibility study of implementation of an in-clinic screening and program referral process consistent with the Fit to Context Framework’s Design Phase (an implementation science approach focused on ensuring that interventions are designed appropriately for the ultimate setting in which they will be delivered). The feasibility and acceptability of electronic screening of both depression and anxiety at regular diabetes appointments will be assessed via documentation of screening rates as well as qualitative interviews and implementation survey measures with clinic staff and providers. This goal is to evaluate the screening and referral process into the program within the ultimate setting in which it will be delivered, if efficacious. The result of the current study, therefore, will be a feasible and acceptable clinic screening and referral process across multiple clinics and an efficacious group-based, virtual intervention tailored for adolescents with T1D designed for the settings in which it will ultimately be implemented. The multidisciplinary and multisite study team contributes complementary areas of expertise in adolescents with T1D, behavioral intervention development, symptoms of depression and anxiety and maladaptive eating behavior, adolescent mindfulness-based intervention, qualitative data analysis, and dissemination and implementation.
