Clinical trial NCT05268393: Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes
Official title: Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: type1diabetes
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-03-07
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Percentage of Enrolled of Eligible Participants Screened
timeFrame: During screening (10 months total)
measure: Number of Weeks to Enroll Participants to Form One Cohort
timeFrame: During screening (10 months)
measure: Percentage of Participants With Data Collected
timeFrame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
measure: Percentage of Attended Sessions
timeFrame: Immediate post-intervention follow-up (2-3 months post baseline)
measure: Satisfaction With Intervention Program
timeFrame: Immediate post-intervention follow-up (2-3 months post-baseline)
Secondary outcomes:
measure: Mindful Attention Awareness Scale
timeFrame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
measure: Five-Facet Mindfulness Questionnaire
timeFrame: Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post-baseline)
measure: PROMIS Depression Short Form - Adolescent Report
timeFrame: Baseline, Immediate post-intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
measure: PROMIS Anxiety Short Form - Adolescent Report
timeFrame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
measure: Diabetes Eating Problems Survey Revised
timeFrame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
measure: UPPS-P Negative Urgency Subscale
timeFrame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
measure: Self-Care Inventory
timeFrame: Baseline, Immediate post-intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
measure: Problem Areas in Diabetes - Teen
timeFrame: Baseline, immediate post intervention (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
measure: Glycemic Control
timeFrame: Baseline, immediate post intervention follow up (2-3 months post baseline), 3 month follow up (5-6 months post baseline)
measure: Interventionist Adherence to Session Manuals
timeFrame: Week 6 of intervention
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
References:
citation: 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.
citation: 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.