The current study aimed to investigate using a superiority framework the efficacy of a combined treatment (cognitive-behavioral therapy based on behavioral components derived from classical behavioral therapy modifications and cognitive components mainly derived from rational emotive behavior therapy, plus an attention training component in a virtual environment (CBT/REBT + ATX, N = 20) as compared to psychotherapy alone (CBT/REBT, delivered over 16 weeks, N = 18—reference treatment) and non-stimulant medication alone (atomoxetine; ATX, N = 21—reference treatment) for children with Attention-Deficit/Hyperactivity Disorder (ADHD).
A three-arm pilot randomized controlled trial was conducted. Fifty-nine children (Mage = 8.46, SD = 1.57) were randomly allocated to one of the 3 conditions.
Our preliminary findings indicated a significant difference between the CBT/REBT + ATX and ATX group at post-treatment for the total ADHD symptoms rated by parent, d = 1.30, 95% CI [0.63, 1.98], p = 0.010.
The combined treatment seems to be superior to the medication alone on parent ratings on ADHD symptoms, however, on clinical ratings on ADHD diagnosis and functioning there are no significant group differences between treatments. Future larger trials with follow-up assessments are needed to test the stability of the effects over time.
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We want to thank Dr. Silviu Matu and Dr. Ioana Cristea for their constructive comments on the manuscript.
This study was supported by National Council for Research (Romania) (Grant No. CEEX Contract no 78 / 2006).
Conflict of interest
Daniel David is Director of Research and a Diplomate/Supervisor at the Albert Ellis Institute, SUA. Anca Dobrean received speaker fee from Eli Lilly. Viorel Lupu received speaker fees from Eli Lilly and Janssen Cilag. Elena Predescu received consulting and speaker fees from Eli Lilly, Janssen Cilag and research support from the Romanian Ministry of Education and Research. Manfred Döpfner received consulting income and research support from Lilly, Medice, Shire, Takeda, and Vifor and research support from the German Research Foundation, German Ministry of Education and Research, German Ministry of Health, and Innovation Fund. He received income as head, supervisor, and lecturer of the School of Child and Adolescent Cognitive Behaviour Therapy at the University Hospital Cologne and as consultant for Child Behaviour Therapy at the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung). He also received royalties from treatment manuals, books and psychological tests published by Beltz, Elsevier, Enke, Guilford, Hogrefe, Huber, Kohlhammer, Schattauer, Springer, Wiley. Costina Ruxandra Păsărelu and Felicia Iftene declared no potential conflict of interests.
All procedures performed involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments.
Informed consent was obtained from all individual participants included in the study.
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Clinical trial registration information: ISRCTN92640175.
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David, D., Dobrean, A., Păsărelu, C.R. et al. Psychotherapy, Atomoxetine or Both? Preliminary Evidence from a Comparative Study of Three Types of Treatment for Attention-Deficit/Hyperactivity Disorder in Children. Cogn Ther Res 45, 149–165 (2021). https://doi.org/10.1007/s10608-020-10157-6