Evaluation of the efficacy and effectiveness of a structured disorder tailored psychotherapy in ADHD in adults: study protocol of a randomized controlled multicentre trial (original) (raw)

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).

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Acknowledgments

Our network on psychotherapy of ADHD is supported by the German Federal Ministry of Education and Research (BMBF; 01GV0605, 01GV0606). Members of the COMPAS group (Comparison of methylphenidate and psychotherapy in adult ADHD study, coordinating investigator: PD Dr. A. Philipsen, Freiburg) are our colleagues at the study sites at Wuerzburg (Department of Child and Adolescent Psychiatry and Psychotherapy, Director: Prof. Dr. A. Warnke, coordinator of the ADHD-NET), Freiburg (Department of Psychiatry and Psychotherapy, Director: Prof. Dr. M. Berger), Homburg (Saarland University Hospital and Saarland University Faculty of Medicine: Institute for Forensic Psychology and Psychiatry, Director: Prof. Dr. M. Roesler), Mannheim (Central Institute for Mental Health: Clinic for Psychiatry and Psychotherapy, Director: Prof. Dr. A. Meyer-Lindenberg), Wuerzburg (Department of Psychiatry, Psychosomatics and Psychotherapy, Director: Prof. Dr. J. Deckert; Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Director: Prof. Dr. A. Warnke), Mainz (Department of Psychiatry and Psychotherapy, Director: Prof. K. Lieb; Department of Child and Adolescent Psychiatry and Psychotherapy, Director: Prof. M. Huss), Essen (Department of Psychiatry and Psychotherapy, Director: Prof. J. Wiltfang), members of the Clinical Trials Center at Freiburg (Director: Prof. Dr. H. Maier-Lenz) as well as members of the Data Monitoring and Safety Committee (Prof. Dr. Dr. H. Remschmidt, Prof. Dr. G. Wassmer, PD Dr. N. Wodarz). Independent supervision is carried out by staff members of the Institute for Psychology of Freiburg University in cooperation with colleagues in private practice. The three other projects of our network on psychotherapy of ADHD (coordinator: Prof. Dr. A. Warnke, Wuerzburg) are coordinated by Prof. A. Warnke and Dr. T. Jans (Wuerzburg, ADHD in Mothers and Children (AIMAC) Study), Prof. Dr. L. Tebartz van Elst (Freiburg, functional and morphometric brain mapping) and Prof. Dr. K.-P. Lesch (Wuerzburg, molecular genetics). We gratefully thank all participating patients and all our Partners for their cooperation. We feel obliged to Dr. Fischer (MEDICE Arzneimittel Puetter GmbH & Co. KG) for his support in providing the trial medication and in preparing the study protocol and case report forms as well as his assistance in SAE management. German Federal Ministry of Education and Research (Bundesministerium fuer Bildung und Forschung, BMBF, ref: 01GV0606). MEDICE Arzneimittel Pütter GmbH & Co. KG (trial medication).

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Authors and Affiliations

1. Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Hauptstr. 5, 79104, Freiburg, Germany
   Alexandra Philipsen, Ludger Tebartz van Elst, Bernd Hesslinger, Dieter Ebert, Swantje Matthies & Mathias Berger
2. Clinical Trials Center, University Medical Center Freiburg, Elsaesser Str. 2, 79110, Freiburg, Germany
   Erika Graf & Gabriele Ihorst
3. Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Wuerzburg, Fuechsleinstr.15, 97080, Wuerzburg, Germany
   Thomas Jans, Andreas Warnke & Manfred Gerlach
4. Department of Psychiatry and Psychotherapy, University of Wuerzburg, Fuechsleinstr.15, 97080, Wuerzburg, Germany
   Christian Jacob & Silke Gross-Lesch
5. Department of Psychiatry, Charite–University Medicine Berlin, Campus Benjamin Franklin, Eschenallee 3, 14050, Berlin, Germany
   Michael Colla & Laura Gentschow
6. Central Institute of Mental Health J5, 68159, Mannheim, Germany
   Esther Sobanski & Barbara Alm
7. Faculty of Medicine, Institute for Forensic Psychology and Psychiatry, Saarland University, Homburg, Germany
   Michael Rösler
8. Department of Psychiatry and Psychotherapy, University of Duisburg-Essen, Duisburg, Germany
   Bernhard Kis
9. Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center, Mainz, Germany
   Michael Huss
10. Department of Psychiatry and Psychotherapy, University Medical Center, Mainz, Germany
    Klaus Lieb
11. Institute for Innovation and Valuation in Health Care, INNOVAL HC, Wiesbaden, Germany
    Michael Schlander
12. Mannheim Medical Faculty, University of Heidelberg, Heidelberg, Germany
    Michael Schlander

Authors

1. Alexandra Philipsen
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2. Erika Graf
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3. Ludger Tebartz van Elst
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4. Thomas Jans
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5. Andreas Warnke
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6. Bernd Hesslinger
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7. Dieter Ebert
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8. Manfred Gerlach
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9. Swantje Matthies
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10. Michael Colla
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11. Christian Jacob
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12. Esther Sobanski
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13. Barbara Alm
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14. Michael Rösler
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15. Gabriele Ihorst
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16. Silke Gross-Lesch
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17. Laura Gentschow
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18. Bernhard Kis
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19. Michael Huss
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20. Klaus Lieb
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21. Michael Schlander
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22. Mathias Berger
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Corresponding author

Correspondence toAlexandra Philipsen.

Additional information

For the COMPAS group (COMPAS: Comparison of methylphenidate and psychotherapy in adult ADHD study; study sites: University Medical Centers of Freiburg, Wuerzburg, Berlin, Saarland, Central Institute of Mental Health Mannheim, University Medical Centers Essen and Mainz).

Appendix

Appendix

• Declaration of Helsinki: http://www.ohsr.od.nih.gov/helsinki.php3.
• ICH-GCP-Guidelines: http://www.ich.org.
• German GCP-bye-law (GCP-Verordnung, GCP-V) vom 09.08.2004, German Pharmaceuticals Act (Arzneimittelgesetz §40-42; 12. AMG-Novelle): http://www.ethik.meb.uni-bonn.de/amg12.html.

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Philipsen, A., Graf, E., Tebartz van Elst, L. et al. Evaluation of the efficacy and effectiveness of a structured disorder tailored psychotherapy in ADHD in adults: study protocol of a randomized controlled multicentre trial.ADHD Atten Def Hyp Disord 2, 203–212 (2010). https://doi.org/10.1007/s12402-010-0046-7

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• Received: 13 August 2010
• Accepted: 29 October 2010
• Published: 30 November 2010
• Issue Date: December 2010
• DOI: https://doi.org/10.1007/s12402-010-0046-7

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