Long-term improvement of quality of life in adult ADHD – results of the randomized multimodal COMPAS trial

Abstract

Attention Deficit Hyperactivity Disorder (ADHD) negatively impacts Quality of Life (QoL) in adults. Earlier studies on pharmacological treatment have shown short-term beneficial effects on QoL. No data are available on long-term effects on multimodal psychosocial and/or pharmacological interventions. The Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS), a prospective, multicenter randomized clinical trial, compared cognitive behavioral group psychotherapy (GPT) with individual clinical management (CM) and methylphenidate (MPH) with placebo (Plac) (2 × 2 factorial design over a period of 52 weeks). Change of QoL was measured after three months of intensive treatment, after 26 weeks, and after one year of maintenance treatment, using the Quality of life enjoyment and satisfaction questionnaire (Q-LES-Q, eight subscales). A follow-up was performed 1.5 years after treatment completion. Q-LES-Q scores were analyzed descriptively (means and confidence intervals). A linear regression model was used to test for significant differences between the four treatment arms. The full analysis set comprised 419 patients. Q-LES-Q scores increased between baseline and the end of treatment across all Q-LES-Q subscales (with exception of stable scores in the physical health/activities subscale in the CM + Plac group) and remained stable improved at follow-up. Regression analyses did not show any significant differences between the four treatment conditions. COMPAS is the first study to demonstrate stable and long-term improvements of QoL after multimodal treatment regardless of medication with MPH or Placebo, and regardless of structured GPT or individual CM. Trial registration: ISRCTN54096201

Keywords:

• Adult ADHD
• quality of life
• methylphenidate
• psychotherapy
• Q-LES-Q

Disclosure statement

EG received personal fees from Roche Pharma AG, outside the submitted work.

SM has been involved in clinical trials conducted by Janssen and Lundbeck as a study physician.

ES has served on advisory boards of MEDICE Arzneimittel Pütter GmbH and Co. KG, Eli Lilly and Co and Shire.

BA performed phase 3 studies with Eli Lilly and Medice.

MR has during the last 3 years been part of advisory boards and speaker for Medice Arzneimittel, Novartis, Shire and Lilly. He has performed phase 3 studies for Medice.

WR has served on the advisory board of MEDICE and has been involved in treatment studies performed by NOVARTIS and MEDICE. He has received royalties for publications concerning diagnostic tools and psychosocial treatment of ADHD from Elsevier, Hogrefe and Kohlhammer publishers.

CJ (2) has received speakers’ honoraria from Shire and Jansen and is a member of the Advisory Board of the Medical Education Steering Committee of the latter company.

MC has served on advisory boards, received speaker’s honoraria, or performed phase 3 studies with Shire, Eli Lilly and Co, and Novartis.

MH has received personal fees, non-financial support or grants within the last 3 years by Shire, MEDICE Arzneimittel Pütter GmbH and Co. KG, Novartis, Eli Lilly, Engelhard Arzneimittel and Actelion. He holds the patents DE 10221839 B4 and US 20050131292 A1 on doppler radar.

BK has served on the advisory board of Medice, Shire and Servier and has received speaking honoraria by MEDICE Arzneimittel Pütter GmbH and Co KG within the last three years.

AL has received speaker `s honoraria and travel grants from Medice Arzneimittel Pütter GmbH and has authored books and articles on ADHD published by Elsevier, Thieme, Springer and Oxford University Press.

MB is a member of the advisory board of the Oberberg Hospital Group and textbook author published by Elsevier.

LT has given talks and workshops on different medical issues including ADHD indirectly payed for by different institutions and pharmaceutical companies. He has received funding for research projects into neurodevelopmental disorders including ADHD from the DFG and BMBF and has published several books and book chapters.

AP has served on advisory boards, given lectures, performed phase 3 studies, or received travel grants within the last 3 years from Eli Lilly and Co, Janssen-Cilag, MEDICE Arzneimittel Pütter GmbH and Co KG, Novartis, and Shire; and has authored books and articles on psychotherapy published by Elsevier, Hogrefe, Schattauer, Kohlhammer, Karger, Springer, and Oxford Press.

All other authors declare that they have no competing interests.