Children's National

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

Purpose

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.

Condition

type1diabetes

Eligibility

Eligible Ages: Between 12 Years and 17 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

age 12-17y - T1D, with at least 1-year duration of illness - negative affectivity, defined as clinically elevated scores (T-score >55 indicating at least mild depression/anxiety symptoms on either the PROMIS short form-depression and/or anxiety scales) - A1c >7.5% - English-speaking

Exclusion Criteria

no cognitive or developmental delays which would interfere with their ability to participate in the study - are able and willing to complete questionnaires and intervention via the internet - do not have severe depression or active or recent (within the past two months) suicidal ideation - have no other serious medical conditions (e.g., cystic fibrosis, cancer).

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental BREATHE-T1D	BREATHE-T1D is a 6-week group mindfulness program adapted specifically for teens with type 1 diabetes.	Behavioral: BREATHE-T1D BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.
Placebo Comparator BREATHE-T1D Health Education	The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive.	Behavioral: BREATHE-T1D BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.

Recruiting Locations

More Details

NCT ID: NCT05268393
Status: Completed
Sponsor: Children's National Research Institute

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.