title: Effects of Group Psychotherapy, Individual Counseling, Methylphenidate, and Placebo in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  isrctn.org Identifier: ISRCTN54096201.
authors.affiliation: Medical Campus University of Oldenburg, School of Medicine and Health Sciences, Psychiatry and Psychotherapy-University Hospital, Karl-Jaspers-Klinik, Bad Zwischenahn, Germany2Department of Psychiatry and Psychotherapy, University Medical Center Freiburg.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Philipsen
authors.affiliation: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Jans
authors.affiliation: Clinical Trials Unit, University Medical Center, University of Freiburg, Freiburg, Germany.
authors.forename: Erika
authors.initials: E
authors.lastname: Graf
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany.
authors.forename: Swantje
authors.initials: S
authors.lastname: Matthies
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany.
authors.forename: Patricia
authors.initials: P
authors.lastname: Borel
authors.affiliation: Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité-University Medicine Berlin, Berlin, Germany6Experimental and Clinical Research Center, Max Delbrück Center for Molecular Medicine and Charité-Campus Berlin-Buch, Berlin, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Colla
authors.affiliation: Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité-University Medicine Berlin, Berlin, Germany6Experimental and Clinical Research Center, Max Delbrück Center for Molecular Medicine and Charité-Campus Berlin-Buch, Berlin, Germany.
authors.forename: Laura
authors.initials: L
authors.lastname: Gentschow
authors.affiliation: Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité-University Medicine Berlin, Berlin, Germany6Experimental and Clinical Research Center, Max Delbrück Center for Molecular Medicine and Charité-Campus Berlin-Buch, Berlin, Germany.
authors.forename: Daina
authors.initials: D
authors.lastname: Langner
authors.affiliation: Department of Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Jacob
authors.affiliation: Department of Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany.
authors.forename: Silke
authors.initials: S
authors.lastname: Groß-Lesch
authors.affiliation: Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
authors.forename: Esther
authors.initials: E
authors.lastname: Sobanski
authors.affiliation: Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
authors.forename: Barbara
authors.initials: B
authors.lastname: Alm
authors.affiliation: Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Schumacher-Stien
authors.affiliation: Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Roesler
authors.affiliation: Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany10Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Retz
authors.affiliation: Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Retz-Junginger
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medical Center Göttingen, Göttingen, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Kis
authors.affiliation: Department of Psychiatry and Psychotherapy, LVR-Hospital Essen, Faculty of Medicine, University of Duisburg-Essen, Duisburg and Essen, Germany.
authors.forename: Mona
authors.initials: M
authors.lastname: Abdel-Hamid
authors.affiliation: Department of Psychiatry and Psychotherapy, LVR-Hospital Essen, Faculty of Medicine, University of Duisburg-Essen, Duisburg and Essen, Germany.
authors.forename: Viola
authors.initials: V
authors.lastname: Heinrich
authors.affiliation: Department of Child and Adolescent Psychiatry and Psychotherapy, University Medicine Mainz, Mainz, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Huss
authors.affiliation: Department of Child and Adolescent Psychiatry and Psychotherapy, University Medicine Mainz, Mainz, Germany.
authors.forename: Catherine
authors.initials: C
authors.lastname: Kornmann
authors.affiliation: Department of Child and Adolescent Psychiatry and Psychotherapy, University Medicine Mainz, Mainz, Germany.
authors.forename: Arne
authors.initials: A
authors.lastname: Bürger
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany.
authors.forename: Evgeniy
authors.initials: E
authors.lastname: Perlov
authors.affiliation: Clinical Trials Unit, University Medical Center, University of Freiburg, Freiburg, Germany.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Ihorst
authors.affiliation: Institute for Innovation and Valuation in Health Care, Wiesbaden, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Schlander
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany.
authors.forename: Mathias
authors.initials: M
authors.lastname: Berger
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany.
authors.forename: Ludger
authors.initials: L
authors.lastname: Tebartz van Elst
mesh_terms: D000293:Adolescent; D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy / Q000523:psychology* / Q000628:therapy*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D003376:Counseling; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000627:therapeutic use*; D008875:Middle Aged; D011615:Psychotherapy, Group; D055815:Young Adult
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate