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

Not Applicable

Completed

Conditions: type1diabetes

Interventions: Behavioral: BREATHE-T1D

Registration Number: NCT05268393

Lead Sponsor: Children's National Research Institute

Brief 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). 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BREATHE-T1D	BREATHE-T1D	BREATHE-T1D is a 6-week group mindfulness program adapted specifically for teens with type 1 diabetes.
BREATHE-T1D Health Education	BREATHE-T1D	The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive.

Primary Outcome Measures

Name	Time	Method
Percentage of Enrolled of Eligible Participants Screened	During screening (10 months total)	The percentage is calculated first by identifying the number of enrolled participants divided by eligible participants. 42 total patients were eligible once screened across the 10 month enrollment period. 42 total then enrolled in the study.
Number of Weeks to Enroll Participants to Form One Cohort	During screening (10 months)	Number of weeks to enroll 10 participants to be randomized 5 per group
Percentage of Participants With Data Collected	Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)	Number of participants with data at each time point.
Percentage of Attended Sessions	Immediate post-intervention follow-up (2-3 months post baseline)	Number of intervention sessions (calculated by multiplying number of expected sessions by number of participants for total possible sessions held) attended divided by total number of intervention sessions expected per group.
Satisfaction With Intervention Program	Immediate post-intervention follow-up (2-3 months post-baseline)	Satisfaction report by participants

Secondary Outcome Measures

Name	Time	Method
Five-Facet Mindfulness Questionnaire	Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post-baseline)	Assessed via teen report. Scores are calculated as a total score across all items in the scale with a range of 1 (minimum) to 5 (maximum) and total scores presented are a sum of the sub scale (observing, describing, acting with awareness, nonjudging, and non-reactivity) with possible scores ranging from 5-25 with higher scores indicating more mindfulness.
Mindful Attention Awareness Scale	Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)	Assessed via teen report. Scores are calculated as an average score of all items with a range of 1 (minimum) to 6 (maximum) with higher scores indicating more mindful attention in daily life.
PROMIS Depression Short Form - Adolescent Report	Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)	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. Interpretation of t-scores is based on a mean of 50 and standard deviation of 10.
PROMIS Anxiety Short Form - Adolescent Report	Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)	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. Interpretation of t-scores is based on a mean of 50 and standard deviation of 10.
Diabetes Eating Problems Survey Revised	Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)	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.
UPPS-P Negative Urgency Subscale	Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)	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).
Self-Care Inventory	Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)	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).
Problem Areas in Diabetes - Teen	Baseline, immediate post intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)	The Problem Areas in Diabetes-Teen (PAID-T) is a 14-item measure of diabetes distress in adolescents with type 1 diabetes. Adolescents are asked how often each diabetes-related problem applied to them in the past month, on a six-point Likert scale (ranging from not a problem to serious problem), with scores reflecting a total across 14 items and higher scores indicating greater severity and a clinical cutoff of \>44. Scores can range from 14-84.
Glycemic Control	Baseline, immediate post intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)	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%.
Interventionist Adherence to Session Manuals	Week 6 of intervention	Supervisors listened to recordings of sessions for both programs and completed checklists assessing for the number of expected intervention components included in the sessions. Therefore, values reflect the percentage of expected intervention components included across all program sessions calculated at the end of the intervention period (week 6) for each group cohort.