Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes - Trial NCT05268393

Timeline & Enrollment

Primary Outcome

Percentage enrolled of eligible participants screened per month,Number of weeks to enroll participants to form one cohort,Percentage of missing assessment data,Percentage of missed sessions per participant,Satisfaction with intervention program,Interventionist adherence to session manuals

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).
 Unfortunately, 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.

ICD-10 Classifications