Design of a randomized controlled trial to decrease depression and improve insulin sensitivity in adolescents: Mood and INsulin sensitivity to prevent Diabetes (MIND).

backgroundDepressive symptoms often manifest in adolescence and predict worsening insulin sensitivity, a key precursor in the path to β-cell failure and type 2 diabetes (T2D).

objectiveTo assess the efficacy of a six-week cognitive-behavioral group versus six-week health education group for improving insulin sensitivity and preserving β-cell function in adolescent girls at-risk for T2D with depressive symptoms and evaluate mechanisms underlying the association between depression and insulin dynamics.

designRandomized controlled trial of N = 150 12-17-year-old girls with overweight/obesity (body mass index [BMI; kg/m2] ≥85th percentile), elevated depressive symptoms (Center for Epidemiologic Studies-Depression Scale [CES-D] total score > 20), and diabetes family history.

methodsGirls at-risk for T2D with elevated depressive symptoms are recruited from the Denver-metropolitan area and randomized to participate in one of two six-week interventions. The cognitive-behavioral group is a depression prevention program involving psycho-education, restructuring negative thoughts, and behavioral activation. The health education group is a didactic control that provides knowledge about healthy living. Participants are assessed at baseline, immediate post-intervention, and one-year follow-up. Primary outcomes are insulin sensitivity and β-cell function from oral glucose tolerance tests. Secondary outcomes are disinhibited eating, physical activity, sleep, and cortisol. SUMMARY: Results from this adequately powered randomized controlled trial will determine whether decreasing depressive symptoms with a behavioral health program preventatively alters insulin sensitivity and β-cell function trajectories in adolescents at-risk for T2D. Results from the MIND Project will add to knowledge of the contribution of depressive symptoms to T2D risk.