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

Study Overview
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Brief Summary
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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.

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

Conditions
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type1diabetes

Intervention / Treatment
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* Behavioral: BREATHE-T1D


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |