Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05268393
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2022-02-15
Brief Title:
Feasibility Trial of a Mindfulness Based Intervention in Youth with Type 1 Diabetes
Sponsor:
Childrens National Research Institute
Organization:
Childrens National Research Institute
Study Overview
Official Title:
Feasibility Trial of a Mindfulness Based Intervention in Youth with Type 1
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BREATHE-T1D
Brief Summary:
Type 1 diabetes T1D is one of the most common chronic illnesses of childhood The involved treatment regimen including daily insulin administrationpump 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 75 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 eg 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 teams 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 studys innovative approach will enable the investigators to establish a feasibleacceptable intervention tailored for adolescents with T1D leading to a future proposal for a full-scale efficacy trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None