Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes

Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood. Theinvolved treatment regimen, including daily insulin administration/pump management,frequent blood glucose checks, and careful track‐ing of food intake, places a high‐stressburden on patients and their families. Adolescence is a particularly risky time for T1Dmanagement given a marked decline in treatment adherence and glycemic control. Over 80%of adolescents with T1D have poor glycemic control (A1c >7.5%), and one significant riskfactor is the increase in negative affectivity, including depression and anxietysymptoms, that distinguish adolescents with T1D. Elevated depression and anxiety symptomsaffect 40% of teens with T1D. Preliminary data support the notion that negativeaffectivity contributes to diminished treatment adherence and worsening of glycemiccontrol, partially through the effects of negative affectivity on stress‐related behaviorsuch as maladaptive eating behavior (e.g., dietary restriction, uncontrolled eatingpatterns, and insulin omission for weight control). There is no gold‐standard approach toaddress the poor glycemic control seen in adolescents with T1D. The creation of novel,targeted interventions, tailored for the developmental needs of adolescents with T1D andthe particular burdens of coping with their chronic illness, are needed.Mindfulness‐based interventions delivered to adolescents without T1D, including theteam's preliminary work in teens with depression and weight‐related disorders, have shownpromise in treating negative affectivity, maladaptive eating behavior, and healthoutcomes. A mindfulness‐based approach may be well‐suited for adolescents with T1D, butgiven that the mechanisms of association among negative affectivity, stress‐relatedbehavior, and self‐care are unique to individuals with T1D, interventions must bespecifically tailored for this population. The goal of this study is to, therefore, adaptan existing 6‐session mindfulness‐based intervention, Learning to BREATHE, for use withadolescents with T1D (BREATHE‐T1D). The first specific aim of the study is to adaptBREATHE for adolescents with T1D and to adapt a relevant and credible health educationcomparison curriculum (HealthEd‐T1D). The second aim is to carry out a 2‐way pilotrandomized controlled trial to evaluate the feasibility and acceptability of BREATHE‐T1Dand HealthEd‐T1D. The result of the current study will be a feasible and acceptablemindfulness intervention and comparison curriculum that can be evaluated in an efficacytrial. The multidisciplinary study team contributes complementary areas of expertise inadolescents with T1D, behavioral intervention development, negative affectivity andmaladaptive eating behavior, adolescent mindfulness‐based intervention, qualitative dataanalysis, and delivery of behavioral health interventions via telehealth. The study'sinnovative approach will enable the investigators to establish a feasible/acceptableintervention tailored for adolescents with T1D, leading to a future proposal for afull‐scale efficacy trial.