title: Evaluation of the efficacy and effectiveness of a structured disorder tailored psychotherapy in ADHD in adults: study protocol of a randomized controlled multicentre trial.
abstract: ADHD is a serious risk factor for co-occurring psychiatric disorders and negative psychosocial consequences in adulthood. Previous trials on psychotherapeutic concepts for adult ADHD are based on behavioural (cognitive behavioural and dialectical behavioural) psychotherapeutic approaches and showed significant effects. The aim of our study group (COMPAS) is to carry out a first randomized and controlled multicentre study to evaluate the effects of a disorder tailored psychotherapy in adult ADHD compared to clinical management in combination with psychopharmacological treatment or placebo. A total of 448 adults with ADHD according to DSM-IV will be treated at seven university sites in Germany. In a four-arm design, patients are randomized to a manualized dialectical behavioural therapy (DBT) based group programme plus methylphenidate or placebo or clinical management plus methylphenidate or placebo with weekly sessions in the first 12 weeks and monthly sessions thereafter. Therapists are graduated psychologists or physicians. Treatment integrity is established by independent supervision. Primary endpoint (ADHD symptoms measured by the Conners Adult Rating Scale) is rated by interviewers blind to the treatment allocation. Intention-to-treat analysis will be performed within a linear regression model (Current Controlled Trials ISRCTN54096201). The trial is funded by the German Federal Ministry of Research and Education (01GV0606) and is part of the German network for the treatment of ADHD in children and adults (ADHD-NET).
authors: Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Germany. alexandra.philipsen@uniklinik-freiburg.de
authors: Alexandra
authors: A
authors: Philipsen
authors: Erika
authors: E
authors: Graf
authors: Ludger
authors: L
authors: Tebartz van Elst
authors: Thomas
authors: T
authors: Jans
authors: Andreas
authors: A
authors: Warnke
authors: Bernd
authors: B
authors: Hesslinger
authors: Dieter
authors: D
authors: Ebert
authors: Manfred
authors: M
authors: Gerlach
authors: Swantje
authors: S
authors: Matthies
authors: Michael
authors: M
authors: Colla
authors: Christian
authors: C
authors: Jacob
authors: Esther
authors: E
authors: Sobanski
authors: Barbara
authors: B
authors: Alm
authors: Michael
authors: M
authors: Rösler
authors: Gabriele
authors: G
authors: Ihorst
authors: Silke
authors: S
authors: Gross-Lesch
authors: Laura
authors: L
authors: Gentschow
authors: Bernhard
authors: B
authors: Kis
authors: Michael
authors: M
authors: Huss
authors: Klaus
authors: K
authors: Lieb
authors: Michael
authors: M
authors: Schlander
authors: Mathias
authors: M
authors: Berger
mesh_terms: D000293:Adolescent; D000328:Adult; D019958:Attention Deficit and Disruptive Behavior Disorders / Q000188:drug therapy* / Q000628:therapy*; D001521:Behavior Therapy / Q000379:methods*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis / Q000379:methods; D008297:Male; D008774:Methylphenidate / Q000627:therapeutic use*; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011615:Psychotherapy, Group / Q000379:methods*; D012720:Severity of Illness Index
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate