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

NCT05268393 | Completed Results DMC

• 2 other identifiers: 15464R34AT011035
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

type1diabetes

Outcome Measures

Primary Outcomes (5)

• Percentage of Enrolled of Eligible Participants Screened

  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.

  During screening (10 months total)

• Number of Weeks to Enroll Participants to Form One Cohort

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

  During screening (10 months)

• Percentage of Participants With Data Collected

  Number of participants with data at each time point.

  Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)

• Percentage of Attended Sessions

  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.

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

• Satisfaction With Intervention Program

  Satisfaction report by participants

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

Secondary Outcomes (10)

• Mindful Attention Awareness Scale

  Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)

• Five-Facet Mindfulness Questionnaire

  Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post-baseline)

• 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)

• PROMIS Anxiety Short Form - Adolescent Report

  Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)

• Diabetes Eating Problems Survey Revised

  Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)

Study Arms (2)

BREATHE-T1D

EXPERIMENTAL

BREATHE-T1D is a 6-week group mindfulness program adapted specifically for teens with type 1 diabetes.

Behavioral: BREATHE-T1D

BREATHE-T1D Health Education

PLACEBO COMPARATOR

The health education placebo comparator is a 6-week group diabetes-specific education program designed to be informational but not supportive.

Behavioral: BREATHE-T1D

Interventions

BREATHE-T1D BEHAVIORAL

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

BREATHE-T1D; BREATHE-T1D Health Education

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Children's National Research Institute: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Children's National Hospital

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

Location

Related Publications (2)

• Lupini F, Basch M, Cooke F, Vagadori J, Gutierrez-Colina A, Kelly KP, Streisand R, Shomaker L, Mackey ER. BREATHE-T1D: Using iterative mixed methods to adapt a mindfulness-based intervention for adolescents with type 1 diabetes: Design and development. Contemp Clin Trials. 2024 Jul;142:107551. doi: 10.1016/j.cct.2024.107551. Epub 2024 Apr 29.

  PMID: 38692428 BACKGROUND

• Basch M, Lupini F, Ho S, Dagnachew M, Gutierrez-Colina AM, Patterson Kelly K, Shomaker L, Streisand R, Vagadori J, Mackey E. Mindfulness-based group intervention for adolescents with type 1 diabetes: initial findings from a pilot and feasibility randomized controlled trial. J Pediatr Psychol. 2024 Oct 1;49(10):769-779. doi: 10.1093/jpepsy/jsae071.

  PMID: 39212647 RESULT

Results Point of Contact

• Title: Dr. Eleanor Mackey
• Organization: Children's National Hospital

emackey@childrensnational.org

202-476-5307

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 7, 2022
• Study Start: March 31, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: February 7, 2025
• Results First Posted: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)