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

type1diabetes Clinical Trial

— BREATHE-T1D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05268393
• Other study ID #: 15464
• Status: Completed
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2024
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• type1diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage enrolled of eligible participants screened per month	Number of enrolled participants per month divided by eligible participants screened per month	Baseline
Primary	Number of weeks to enroll participants to form one cohort	Number of weeks to enroll 10 participants to be randomized 5 per group	Baseline
Primary	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
Primary	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
Primary	Satisfaction with intervention program	Satisfaction report by participants	Immediate post-intervention follow-up
Primary	Interventionist adherence to session manuals	Ratings of adherence to manual of program sessions by investigators	Immediate post-intervention follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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