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Open Access Highly Accessed Study protocol

Early specific cognitive-behavioural psychotherapy in subjects at high risk for bipolar disorders: study protocol for a randomised controlled trial

Andrea Pfennig1*, Karolina Leopold1, Andreas Bechdolf23, Christoph U Correll4, Martin Holtmann5, Martin Lambert6, Carolin Marx1, Thomas D Meyer7, Steffi Pfeiffer1, Andreas Reif8, Maren Rottmann-Wolf1, Natalie M Schmitt1, Thomas Stamm9, Georg Juckel10 and Michael Bauer1

Author Affiliations

1 Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Fetscherstrasse 74, 01307 Dresden, Germany

2 Department of Psychiatry, Psychotherapy and Psychosomatics, Vivantes Hospital Urban, Berlin, Germany

3 Department of Psychiatry and Psychotherapy, University Hospital Cologne, Cologne, Germany

4 Division of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, NY, USA

5 Child and Adolescent Psychiatry, LWL-University Hospital for Child and Adolescent Psychiatry, Ruhr-University Bochum, Hamm, Germany

6 Psychosis Centre, Department of Psychiatry and Psychotherapy, Center of Psychosocial Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany

7 Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK

8 Department of Psychiatry, Psychosomatics and Psychotherapy, University Hospital Würzburg, Würzburg, Germany

9 Department of Psychiatry and Psychotherapy, Charite-University Medicine Berlin, Berlin, Germany

10 LWL University Hospital and Department of Psychiatry, Psychotherapy and Preventive Medicine, Ruhr University Bochum, Hamm, Germany

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Trials 2014, 15:161  doi:10.1186/1745-6215-15-161

Published: 8 May 2014

Abstract

Background

Bipolar disorders (BD) are among the most severe mental disorders with first clinical signs and symptoms frequently appearing in adolescence and early adulthood. The long latency in clinical diagnosis (and subsequent adequate treatment) adversely affects the course of disease, effectiveness of interventions and health-related quality of life, and increases the economic burden of BD. Despite uncertainties about risk constellations and symptomatology in the early stages of potentially developing BD, many adolescents and young adults seek help, and most of them suffer substantially from symptoms already leading to impairments in psychosocial functioning in school, training, at work and in their social relationships. We aimed to identify subjects at risk of developing BD and investigate the efficacy and safety of early specific cognitive-behavioural psychotherapy (CBT) in this subpopulation.

Methods/Design

EarlyCBT is a randomised controlled multi-centre clinical trial to evaluate the efficacy and safety of early specific CBT, including stress management and problem solving strategies, with elements of mindfulness-based therapy (MBT) versus unstructured group meetings for 14 weeks each and follow-up until week 78. Participants are recruited at seven university hospitals throughout Germany, which provide in- and outpatient care (including early recognition centres) for psychiatric patients. Subjects at high risk must be 15 to 30 years old and meet the combination of specified affective symptomatology, reduction of psychosocial functioning, and family history for (schizo)affective disorders. Primary efficacy endpoints are differences in psychosocial functioning and defined affective symptomatology at 14 weeks between groups. Secondary endpoints include the above mentioned endpoints at 7, 24, 52 and 78 weeks and the change within groups compared to baseline; perception of, reaction to and coping with stress; and conversion to full BD.

Discussion

To our knowledge, this is the first study to evaluate early specific CBT in subjects at high risk for BD. Structured diagnostic interviews are used to map the risk status and development of disease. With our study, the level of evidence for the treatment of those young patients will be significantly raised.

Trial registration

WHO International Clinical Trials Platform (ICTRP), identifier: DRKS00000444, date of registration: 16 June 2010.

Keywords:
Bipolar disorders; Early recognition; Early intervention; Cognitive-behavioural psychotherapy; Intervention study; Randomised controlled trial