Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes
Condition: type1diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      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 track-ing 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 glycemic control. Over 80% of adolescents with T1D
      have poor glycemic control (A1c >7.5%), and one significant risk factor is the increase in
      negative affectivity, including depression and anxiety symptoms, that distinguish adolescents
      with T1D. Elevated depression and anxiety symptoms affect 40% of teens with T1D. Preliminary
      data support the notion that negative affectivity contributes to diminished treatment
      adherence and worsening of glycemic control, 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). There is
      no gold-standard approach to address the poor glycemic control seen in adolescents with T1D.
      The creation of novel, targeted interventions, tailored for the developmental needs of
      adolescents with T1D and the particular burdens of coping with their chronic illness, are
      needed. Mindfulness-based interventions delivered to adolescents without T1D, including the
      team's preliminary work in teens with depression and weight-related disorders, have shown
      promise in treating negative affectivity, maladaptive eating behavior, and health outcomes. A
      mindfulness-based approach may be well-suited for adolescents with T1D, but given that the
      mechanisms of association among negative affectivity, stress-related behavior, and self-care
      are unique to individuals with T1D, interventions must be specifically tailored for this
      population. The goal of this study is to, therefore, adapt an existing 6-session
      mindfulness-based intervention, Learning to BREATHE, for use with adolescents with T1D
      (BREATHE-T1D). The first specific aim of the study is to adapt BREATHE for adolescents with
      T1D and to adapt a relevant and credible health education comparison curriculum
      (HealthEd-T1D). The second aim is to carry out a 2-way pilot randomized controlled trial to
      evaluate the feasibility and acceptability of BREATHE-T1D and HealthEd-T1D. The result of the
      current study will be a feasible and acceptable mindfulness intervention and comparison
      curriculum that can be evaluated in an efficacy trial. The multidisciplinary study team
      contributes complementary areas of expertise in adolescents with T1D, behavioral intervention
      development, negative affectivity and maladaptive eating behavior, adolescent
      mindfulness-based intervention, qualitative data analysis, and delivery of behavioral health
      interventions via telehealth. The study's innovative approach will enable the investigators
      to establish a feasible/acceptable intervention tailored for adolescents with T1D, leading to
      a future proposal for a full-scale efficacy trial.
    


Intervention name(s): BREATHE-T1D
Intervention type(s): Behavioral
Intervention description(s): BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment