Clinical trial NCT06618027: Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth With Type 1 Diabetes
Official title: Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Type 1 Diabetes (T1D)
Keywords: type 1 diabetes
adolescents
depression
anxiety
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Barbara Davis Center of Childhood Diabetes, University of Co
name: Colorado State University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 13
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 a common chronic illness among children requiring a high degree of self-management for good glycemic control. Adolescents are at risk for poor disease management and health outcomes due to a number of factors, including high rates of depression, anxiety, and stress. Accessing support for these challenges can be a barrier to care, so the current study, BRinging Empowerment and Attention to Teen HEalth-T1D, evaluates the efficacy of a virtual, group-based mindfulness based intervention and a virtual group-based diabetes education intervention on improving symptoms of depression and anxiety, and diabetes self management in teens with T1D. The study also aims to study how these interventions might be implemented in diabetes clinic settings.

Detailed description: Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood affecting around 200,000 youth in the US. Youth with T1D are at heightened risk for serious adverse health consequences as compared to their peers without T1D, but treatment adherence markedly reduces this risk. Adolescence is a critical period for determining the course of T1D as treatment adherence and glycemic target achievements deteriorate in adolescence, with \~80% failing to meet glycemic targets. Adolescents' failure to adhere to standards of treatment can result in poor glycemic control (HbA1c \&gt;7.0%), which if unaddressed, increases the risk of serious adverse health consequences. Effective intervention to address glycemic control in adolescents with T1D remains elusive. Negative affect-including depression and anxiety-increases during adolescence and is a key contributor to treatment non-adherence and glycemic control above targets. As many as 40% of adolescents with T1D have elevated depression and anxiety symptoms, which likely impact adherence and glycemia through stress-related behavior (e.g., disordered eating, avoidant coping). Trials of effective interventions to decrease negative affect and downstream, stress-related behaviors are critical to improve the health of adolescents with T1D.

Our pilot study adapted a brief group mindfulness-based intervention (MBI) for teens with T1D utilizing stakeholder input and designed with an iterative approach (BREATHE-T1D). Our R34 demonstrated that BREATHE-T1D was highly feasible (100% of eligible teens approached enrolled with a 93% retention rate) and demonstrated outstanding acceptability, with teens participating in 98% of sessions and reporting high value of participation. Those randomized to BREATHE-T1D had evidence of more clinical improvement for depression and HbA1c while those in the health education comparison had stability or worsening of symptoms. Improvements over time were seen in anxiety, diabetes distress, and disordered eating for participants. Existing data from randomized controlled trials (RCT) support the efficacy of MBI for decreasing negative affect and stress-related behavior in adolescents without T1D. The next step is to evaluate the efficacy of BREATHE-T1D in a 2-site study as compared to our health education attention control (HealthEd-T1D). In our R34, providers noted that many adolescents have psychosocial concerns, yet there are grossly inadequate referral sources and a need for integration of efficacious programs into clinic settings. Therefore, it is critical to design interventions for implementation and sustainability and evaluate how the intervention is aligned with infrastructure in real world settings.

The current study is a partnership with Children's National and the University of Colorado to conduct an RCT comparing BREATHE-T1D and HealthEd-T1D in N=200 adolescents 13-17y with \&gt;1 year duration of T1D and elevated negative affect. This study is a pragmatic trial to evaluate the efficacy of BREATHE-T1D and methods of implementation of this program into the clinic setting for which it is designed. Given the positive response to the pilot trial, the value of evaluating screening and referral in clinic, increased emphasis on in-clinic screening for mood, anxiety, and disordered eating, and evaluating outcomes relevant to the clinic setting enables both evaluation of efficacy as well as feasibility of clinic implementation. The intervention will be conducted virtually and the trial will employ multi-method assessment of outcomes including self-report, parent-report, and indica-tors of diabetes management (i.e., blood glucose variability via Continuous Glucose Monitors or blood glucose meters and glycemic control via HbA1c). N=200 adolescents will be randomized 1:1 to BREATHE-T1D or HealthEd-T1D and have a baseline assessment, 7 weeks of groups, and follow-ups 3 months and 1 year following baseline.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes diagnosed for at least 1 year
* Elevated score on depression measure OR elevated score on anxiety measure

Exclusion Criteria:

* Cognitive or developmental delays that restrict ability to complete study interventions or assessments
* Teen not fluent in English
* No other serious medical conditions (e.g., cystic fibrosis, cancer)

Primary outcomes:
measure: Glycemic control
timeFrame: Baseline, 3-, and 12-months post intervention
measure: Depression
timeFrame: Baseline, 3-, and 12-months post intervention
Secondary outcomes:
measure: Anxiety
timeFrame: Baseline, 3-, and 12-months post intervention
measure: Disordered Eating
timeFrame: Baseline, 3-, and 12-months post intervention
measure: Mindfulness
timeFrame: Baseline, 3-, and 12-months post intervention
measure: Mindfulness
timeFrame: Baseline, 3-, and 12- months
measure: Stress
timeFrame: Baseline, 3-, and 12-months post intervention
measure: Executive Functioning
timeFrame: Baseline, 3-, and 12-months post intervention
measure: Negative Urgency
timeFrame: Baseline, 3-, and 12-months post intervention
measure: Avoidant Coping
timeFrame: Baseline, 3-, and 12-months post intervention
measure: Diabetes Distress
timeFrame: Baseline, 3-, and 12-months post intervention
measure: Diabetes Self-Management
timeFrame: Baseline, 3-, and 12-months post intervention
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: Washington
country: United States
facility: Children&#39;s National Hospital
state: District of Columbia
Study officials:
affiliation: children&#39;s national hospital
name: Eleanor Mackey, PhD
role: PRINCIPAL_INVESTIGATOR
References: