Mindfulness-based intervention for depression and insulin resistance in adolescents: Protocol for BREATHE, a multisite, pilot and feasibility randomized controlled trial

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.