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Completed

NCT Number: NCT05268393

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

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.

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Key information

Conditions

Type1diabetes

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

BREATHE-T1D

Behavioral

BREATHE-T1D is a mindfulness based intervention adapted from Learning to BREATHE specifically for teens with type 1 diabetes.

Primary outcomes

  1. Percentage of Enrolled of Eligible Participants Screened

    Time frame: 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.

  2. Number of Weeks to Enroll Participants to Form One Cohort

    Time frame: During screening (10 months)

    Number of weeks to enroll 10 participants to be randomized 5 per group

  3. Percentage of Participants With Data Collected

    Time frame: 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.

  4. Percentage of Attended Sessions

    Time frame: 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.

  5. Satisfaction With Intervention Program

    Time frame: Immediate post-intervention follow-up (2-3 months post-baseline)

    Satisfaction report by participants

Secondary outcomes

  1. Mindful Attention Awareness Scale

    Time frame: 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.

  2. Five-Facet Mindfulness Questionnaire

    Time frame: 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.

  3. PROMIS Depression Short Form - Adolescent Report

    Time frame: 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.

  4. PROMIS Anxiety Short Form - Adolescent Report

    Time frame: 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.

  5. Diabetes Eating Problems Survey Revised

    Time frame: 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.

  6. UPPS-P Negative Urgency Subscale

    Time frame: 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).

  7. Self-Care Inventory

    Time frame: 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).

  8. Problem Areas in Diabetes - Teen

    Time frame: 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.

  9. Glycemic Control

    Time frame: 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%.

  10. Interventionist Adherence to Session Manuals

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Acronym: BREATHE-T1D

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2022
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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