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

NCT ID: NCT05268393

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2023-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BREATHE-T1D

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

Group Type: EXPERIMENTAL

BREATHE-T1D

Intervention Type: BEHAVIORAL

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

BREATHE-T1D Health Education

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

Group Type: PLACEBO_COMPARATOR

BREATHE-T1D

Intervention Type: BEHAVIORAL

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

Interventions

BREATHE-T1D

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Eleanor Mackey

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's National Hospital

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

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 38692428 (View on PubMed)

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.

Reference Type: RESULT

PMID: 39212647 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R34AT011035

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15464

Identifier Type: -

Identifier Source: org_study_id