RESUMEN
BACKGROUND: Negative affect is prevalent among adolescents with type 1 diabetes (T1D) and may impact diabetes self-management and outcomes through stress-related behaviors such as disordered eating. METHODS: We describe the development of and design for the adaptation of a mindfulness-based intervention (MBI) for adolescents with T1D and negative affect. BREATHE-T1D is an MBI designed to target negative affect that has been tailored to address the unique lived experiences of adolescents with T1D. Qualitative interviews with stakeholders and participants were used to inform iterative adaptations to the intervention and control curricula over the course of the study. The primary aim of this paper is to describe the design, development, and protocol of the present pilot feasibility trial. CONCLUSIONS: Iterative, qualitative methodology throughout the adaptation of an intervention is important for ensuring the resulting intervention is relevant and meaningful for the target population. CLINICAL TRIAL REGISTRATION NUMBER: NCT05268393.
RESUMEN
BACKGROUND: Elevated depression symptoms have been associated with higher insulin resistance in adolescents, and consequently, greater risk for type 2 diabetes (T2D). Mindfulness-based intervention (MBI) may be suited for adolescents at risk for T2D given its potential to decrease depression and improve stress-related behavior/physiology underpinning insulin resistance. To prepare for a future multisite efficacy randomized controlled trial, a rigorous, multisite, pilot and feasibility study is needed to test this approach. The current paper describes the design and protocol for a multisite, pilot and feasibility randomized controlled trial of six-week MBI, cognitive-behavioral therapy (CBT), and health education (HealthEd) group interventions, to assess multisite fidelity, feasibility, and acceptability. METHODS: Participants are N = 120 adolescents ages 12-17, with body mass index (BMI) ≥85th percentile, elevated depression symptoms (20-item Center for Epidemiologic Studies-Depression Scale total score > 20), and family history of diabetes. Enrollment occurs across four United States (US) sites, two in Colorado, one in Washington, D·C., and one in Maryland. Group interventions are delivered virtually by trained psychologists and co-facilitators. Assessments occur at baseline, six-week follow-up, and one-year follow-up. RESULTS: Primary outcomes are intervention implementation fidelity, based upon expert ratings of audio-recorded sessions (≥80% adherence/competence), and recruitment feasibility, based upon percentage enrollment of eligible youth (≥80%). Secondary outcomes are intervention training fidelity/feasibility/acceptability, recruitment timeframe, and retention/assessment feasibility. CONCLUSION: Findings will inform optimization of training, recruitment, intervention delivery, retention, and assessment protocols for a multisite, efficacy randomized controlled trial evaluating MBI for decreasing depression and improving insulin resistance in adolescents at risk for developing T2D.
