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Clinical Trial
. 2025 Apr;275(3):653-665.
doi: 10.1007/s00406-024-01784-1. Epub 2024 Apr 16.

Bright light therapy versus physical exercise to prevent co-occurring depression in adolescents and young adults with attention-deficit/hyperactivity disorder: a multicentre, three-arm, randomised controlled, pilot phase-IIa trial

Affiliations
Clinical Trial

Bright light therapy versus physical exercise to prevent co-occurring depression in adolescents and young adults with attention-deficit/hyperactivity disorder: a multicentre, three-arm, randomised controlled, pilot phase-IIa trial

Jutta S Mayer et al. Eur Arch Psychiatry Clin Neurosci. 2025 Apr.

Abstract

Depression is common in attention-deficit/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 effects 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 findings suggest that the m-health approach did not achieve feasibility of EI and BLT in young people with ADHD. Prior to designing efficacy studies, strategies how to achieve high intervention adherence should be specifically investigated in this patient group. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03371810, 13 December 2017.

Keywords: Attention-deficit/hyperactivity disorder; Bright light therapy; Depression; Obesity; Physical exercise; Randomised controlled trial; m-Health.

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Figures

Fig. 1
Fig. 1
Trial profile and analysis sets. BLT bright light therapy, EI exercise intervention, IDS-C30 inventory of depressive symptomatology, mITT modified intention-to-treat set, PP per-protocol set, TAU treatment-as-usual
Fig. 2
Fig. 2
Adherence to interventions. Percentage of conducted sessions (in steps of 10%) is shown (BLT, n = 60; EI, n = 59). BLT, bright light therapy; EI, exercise intervention

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