Pilot randomized-controlled phase-IIa trial on the prevention of comorbid depression and obesity in attention-deficit/ hyperactivity disorder - CoCA-PROUD

Depression is common in attention-defcit/hyperactivity disorder (ADHD), but preventive behavioural interventions are lacking. This randomised controlled, pilot phase-IIa trial aimed to study a physical exercise intervention (EI) and bright light therapy (BLT)—both implemented and monitored in an individual, naturalistic setting via a mobile health (m-health) system—for feasibility of trial design and interventions, and to estimate their efects on depressive symptoms in young people with ADHD. Two hundred seven participants aged 14–45 years were randomised to 10-week add-on intervention of either BLT (10,000 lx; daily 30-min sessions) (n=70), EI (aerobic and muscle-strengthening activities 3 days/ week) (n=69), or treatment-as-usual (TAU) (n=68), of whom 165 (80%) were retained (BLT: n=54; EI: n=52; TAU: n=59). Intervention adherence (i.e.= 80% completed sessions) was very low for both BLT (n=13, 22%) and EI (n=4, 7%). Usability of the m-health system to conduct interventions was limited as indicated by objective and subjective data. Safety was high and comparable between groups. Changes in depressive symptoms (assessed via observer-blind ratings, Inventory of Depressive Symptomatology) between baseline and end of intervention were small (BLT: -0.124 [95% CI: -2.219, 1.971], EI: -2.646 [95% CI: -4.777, -0.515], TAU: -1.428 [95% CI: -3.381, 0.526]) with no group differences [F(2,153)=1.45, p=0.2384]. These fndings suggest that the m-health approach did not achieve feasibility of EI and BLT in young people with ADHD. Prior to designing efcacy studies, strategies how to achieve high intervention adherence should be specifcally investigated in this patient group.