Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes (BREATHE-T1D)

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

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.

Study Overview

• Status: Completed
• Conditions: type1diabetes
• Intervention / Treatment: Behavioral: BREATHE-T1D

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage enrolled of eligible participants screened per month	Number of enrolled participants per month divided by eligible participants screened per month	Baseline
Number of weeks to enroll participants to form one cohort	Number of weeks to enroll 10 participants to be randomized 5 per group	Baseline
Percentage of missing assessment data	Number of data points collected per participant divided by total number of data points expected	Baseline, Immediate post-intervention follow up, 3 month follow up
Percentage of missed sessions per participant	Number of intervention sessions per participant divided by total number of intervention sessions expected	Immediate post-intervention follow-up
Satisfaction with intervention program	Satisfaction report by participants	Immediate post-intervention follow-up
Interventionist adherence to session manuals	Ratings of adherence to manual of program sessions by investigators	Immediate post-intervention follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindful Attention Awareness Scale	Assessed via teen report. Scores are calculated as an average score with a range of 1 (minimum) to 6 (maximum) with higher scores indicating more mindful attention in daily life.	Baseline, Immediate post-intervention follow up, 3 month follow up
Five-Facet Mindfulness Questionnaire	Assessed via teen report. Scores are calculated as an average score with a range of 1 (minimum) to 5 (maximum) with higher scores indicating more mindfulness.	Baseline, Immediate post-intervention follow up, 3 month follow up
PROMIS Depression Short Form - Adolescent Report	Scores are calculated as t-scores with higher scores indicating more depressive symptoms. T-scores (range 0-100) over 55 indicate clinically significant depressive symptoms.	Baseline, Immediate post-intervention follow up, 3 month follow up
PROMIS Anxiety Short Form - Adolescent Report	Scores are calculated as t-scores (range 0-100) with higher scores indicating more anxiety symptoms.T-scores over 55 indicate clinically significant anxiety symptoms.	Baseline, Immediate post-intervention follow up, 3 month follow up
Diabetes Eating Problems Survey Revised	Teen report with higher scores indicating more disordered eating behaviors with scores over 25 indicating clinically significant problems. Total scores range from 0 to 64 with higher scores indicating more disordered eating behaviors.	Baseline, Immediate post-intervention follow up, 3 month follow up
UPPS-P Negative Urgency subscale	Teen report on the UPPS-P Negative Urgency subscale with higher scores indicating more likelihood to act impulsively when experiencing a negative mood. Scores are calculated with an average which can range from 1(minimum) to 4 (maximum).	Baseline, Immediate post-intervention follow up, 3 month follow up
Self-Care Inventory	Teen report on the Self-Care Inventory, a measure of diabetes management with higher scores indicating better self-care for diabetes. Average scores range from 1 (minimum) to 5 (maximum).	Baseline, Immediate post-intervention follow up, 3 month follow up
Problem Areas in Diabetes - Teen	Teen report on the Problem Areas in Diabetes - Teen with higher scores indicating more distress related to diabetes. Average scores range from 1 (minimum) to 6 (maximum).	Baseline, Immediate post-intervention follow up, 3 month follow up
Glycemic control	HbA1c is a measure of an average blood glucose level over the past 3 months and will be abstracted from the medical record as it is assessed at each regular diabetes clinic visit. HbA1c typically ranges from 4% to >14%.	Baseline, Immediate post-intervention follow up, 3 month follow up

Collaborators and Investigators

• Sponsor: Children's National Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 15464

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No