Mindfulness-based intervention for depression and insulin resistance in adolescents: Protocol for BREATHE, a multisite, pilot and feasibility randomized controlled trial.
Contemporary Clinical Trials June 1, 2024 Natalia Sanchez, Michele Chen, Sally Ho et al. 3 citations
A protocol for a multisite pilot and feasibility randomized controlled trial compares a six-week mindfulness-based intervention, cognitive-behavioral therapy, and health education groups for 120 adolescents ages 12-17 with elevated depression symptoms, body mass index at or above the 85th percentile, and a family history of diabetes. The trial, conducted across four U.S. sites, aims to assess intervention fidelity, recruitment feasibility, and acceptability. Primary outcomes include at least 80% adherence to intervention protocols and at least 80% enrollment of eligible youth. Findings will guide the design of a future multisite efficacy trial evaluating whether mindfulness can reduce depression and improve insulin resistance in adolescents at risk for type 2 diabetes.