Mindfulness-based intervention for depression and insulin resistance in adolescents: Protocol for BREATHE, a multisite, pilot and feasibility randomized controlled trial.
Natalia Sanchez, Michele Chen, Sally Ho, Holly Spinner, Jack Vagadori, Abigail Neiser, Kimberly Padilla, Madison Bristol, Elijah Winfield, Isabel Thorstad, Lauren D Gulley, Rachel G Lucas-thompson, Laura Pyle, Talia Thompson, Doris E Estrada, Molly Basch, Marian Tanofsky-kraff, Megan M Kelsey, Eleanor R Mackey, Lauren B Shomaker
Contemporary clinical trials June 1, 2024 DOI: 10.1016/j.cct.2024.107522
Summary
Elevated depression symptoms in adolescents are linked to increased insulin resistance, raising the risk of type 2 diabetes. A pilot study involving 120 participants aged 12-17, with a BMI ≥85th percentile and significant depression, is testing a six-week mindfulness-based intervention (MBI) against cognitive-behavioral therapy and health education. Conducted across four U.S. sites, the study aims for over 80% adherence to protocols and successful recruitment of eligible youth. Results will guide future trials focused on reducing depression and improving insulin resistance among at-risk adolescents.
Abstract
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. 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. 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. 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.