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Original Investigation |

Effects of Group Psychotherapy, Individual Counseling, Methylphenidate, and Placebo in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder A Randomized Clinical Trial

Alexandra Philipsen, MD1,2; Thomas Jans, PhD3; Erika Graf, PhD4; Swantje Matthies, MD2; Patricia Borel2; Michael Colla, MD5,6; Laura Gentschow5,6; Daina Langner, PhD5,6; Christian Jacob, MD7; Silke Groß-Lesch, MD7; Esther Sobanski, MD8; Barbara Alm, MD8; Martina Schumacher-Stien8; Michael Roesler, MD9; Wolfgang Retz, MD9,10; Petra Retz-Junginger, PhD9; Bernhard Kis, MD11; Mona Abdel-Hamid, PhD12; Viola Heinrich12; Michael Huss, MD13; Catherine Kornmann13; Arne Bürger13; Evgeniy Perlov, MD2; Gabriele Ihorst, PhD4; Michael Schlander, MBA14; Mathias Berger, MD2; Ludger Tebartz van Elst, MD2 ; for the Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS) Consortium
[+] Author Affiliations
1Medical Campus University of Oldenburg, School of Medicine and Health Sciences, Psychiatry and Psychotherapy–University Hospital, Karl-Jaspers-Klinik, Bad Zwischenahn, Germany
2Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany
3Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany
4Clinical Trials Unit, University Medical Center, University of Freiburg, Freiburg, Germany
5Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité–University Medicine Berlin, Berlin, Germany
6Experimental and Clinical Research Center, Max Delbrück Center for Molecular Medicine and Charité–Campus Berlin-Buch, Berlin, Germany
7Department of Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany
8Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany
9Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany
10Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany
11Department of Psychiatry and Psychotherapy, University Medical Center Göttingen, Göttingen, Germany
12Department of Psychiatry and Psychotherapy, LVR-Hospital Essen, Faculty of Medicine, University of Duisburg-Essen, Duisburg and Essen, Germany
13Department of Child and Adolescent Psychiatry and Psychotherapy, University Medicine Mainz, Mainz, Germany
14Institute for Innovation and Valuation in Health Care, Wiesbaden, Germany
JAMA Psychiatry. 2015;72(12):1199-1210. doi:10.1001/jamapsychiatry.2015.2146.
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Importance  Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder with high prevalence in adulthood. There is a recognized need to assess the efficacy of psychotherapy in adult ADHD.

Objective  To evaluate the efficacy of cognitive behavioral group psychotherapy (GPT) compared with individual clinical management (CM) and that of methylphenidate hydrochloride compared with placebo.

Design, Setting, and Participants  Prospective, multicenter, randomized clinical trial of 18- to 58-year-old outpatients with ADHD from 7 German study centers. Patients were recruited between January 2007 and August 2010, treatment was finalized in August 2011, and final follow-up assessments occurred in March 2013.

Interventions  Sessions of GPT and CM were held weekly for the first 12 weeks and monthly thereafter (9 months). Patients received either methylphenidate or placebo for 1 year.

Main Outcomes and Measures  The primary outcome was the change in the ADHD Index of the Conners Adult ADHD Rating Scale from baseline to the end of the 3-month intensive treatment (blinded observer ratings). Secondary outcomes included ADHD ratings after 1 year, blinded observer ratings using the Clinical Global Impression Scale, and self-ratings of depression.

Results  Among 1480 prescreened patients, 518 were assessed for eligibility, 433 were centrally randomized, and 419 were analyzed as randomized. After 3 months, the ADHD Index all-group baseline mean of 20.6 improved to adjusted means of 17.6 for GPT and 16.5 for CM, with no significant difference between groups. Methylphenidate (adjusted mean, 16.2) was superior to placebo (adjusted mean, 17.9) (difference, −1.7; 97.5% CI, −3.0 to −0.4; P = .003). After 1 year, treatment effects remained essentially stable. Descriptive analyses showed that methylphenidate was superior to placebo in patients assigned to GPT (difference, −1.7; 95% CI, −3.2 to −0.1; P = .04) or CM (difference, −1.7; 95% CI, −3.3 to −0.2; P = .03). Regarding depression, no significant differences were found. In contrast, GPT was superior to CM for all visits in the Clinical Global Impression global assessment of effectiveness.

Conclusion and Relevance  Highly structured group intervention did not outperform individual CM with regard to the primary outcome. Psychological interventions resulted in better outcomes during a 1-year period when combined with methylphenidate as compared with placebo.

Trial Registration  isrctn.org Identifier: ISRCTN54096201

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Figure 1.
Trial Design and Flow of Patients

AE indicates adverse event; CM, clinical management; GPT, group psychotherapy; ICWD, informed consent withdrawn; PW, patient wish; T2, time 2 (week 13); and T4, time 4 (week 52). Details on enrollment are described by Philipsen et al.30

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Figure 2.
Mean Attention-Deficit/Hyperactivity Disorder (ADHD) Index Scores by Randomized Intervention for the 419 Participants in the Full Analysis Set

Means (last mean carried forward) for the primary outcome measure, observer-rated Conners Adult ADHD Rating Scale ADHD Index, for group psychotherapy and clinical management (A), methylphenidate and placebo (B), and group psychotherapy with methylphenidate, group psychotherapy with placebo, clinical management with methylphenidate, and clinical management with placebo. Error bars indicate 95% CIs.

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