Design of an international multicentre RCT on group schema therapy for borderline personality disorder

BMC Psychiatry

Arnoud Arntz⁴  Gerhard Zarbock^1,12  Teresa Stevenson²  Helen Startup¹  Ulrich Schweiger^1,15  Ioannis A Malogiannis⁵  George Lockwood^1,16  Anna Lavender¹  R Patrick Harper⁷  Heather Fretwell^1,17  Eva Fassbinder³  Gerard van Breukelen^1,10  Odette Brand⁸  Christopher W Lee^1,14  Gitta A Jacob⁹  Silvia MAA Evers^1,11  Joan Farrell^1,13  Pim Wetzelaer⁶ 

[1] South London and Maudsley NHS Foundation Trust, London, UK;Peel and Rockingham Kwinana Mental Health Service, Cnr Clifton and Ameer Street, Rockingham 6968, WA, Australia;Department of Psychiatry and Psychotherapy, University of Lübeck, Ratzeburger Allee 160, Lübeck, 23538, Germany;Department of Clinical Psychology, University of Amsterdam, Weesperplein 4, Amsterdam, 1018 XA, The Netherlands;Greek Society of Schema Therapy, 17, Sisini str, Athens, 115 28, Greece;Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, 6229 ER Maastricht, Maastricht, 6200, MD, The Netherlands;Bradford District Care Trust, Bradford, UK;De Viersprong, The Netherlands Institute for Personality Disorders, De Beeklaan 2, Halsteren, 4661, EP, The Netherlands;Department of Clinical Psychology and Psychotherapy, Institute for Psychology, University of Freiburg, Engelbergerstrasse 41, Freiburg, 79085, Germany;Department of Methodology and Statistics, Faculty of Health Medicine and Life Sciences, Maastricht University, Peter Debyeplein 1, Maastricht, 6200, MD, The Netherlands;Trimbos Institute, The Netherlands Institute of Mental Health and Addiction, Utrecht, The Netherlands;IVAH GmbH (Institute for Training in CBT), Hans-Henny-Jahnn-Weg 51, Hamburg, 22085, Germany;Center for Borderline Personality Disorder Treatment & Research, Indianapolis, USA;Department of Psychology and Exercise Science, Murdoch University, 90 South St, Murdoch 6153, WA, Australia;Klinik für Psychiatrie und Psychotherapie, University of Lübeck, Ratzeburger Allee 160, Lübeck, 23538, Germany;Schema Therapy Institute Midwest, 471 West South Street, Suite 41C, Kalamazoo 49007, MI, USA;Department of Psychiatry, Indiana University School of Medicine, Indianapolis, USA

关键词: Cost-effectiveness;    Economic evaluation;    RCT;    Group schema therapy;    Borderline personality disorder;   

Others  :  1092298
DOI  :  10.1186/s12888-014-0319-3

 received in 2014-09-18, accepted in 2014-10-27,  发布年份 2014

【 摘 要 】

Background

Borderline personality disorder (BPD) is a severe and highly prevalent mental disorder. Schema therapy (ST) has been found effective in the treatment of BPD and is commonly delivered through an individual format. A group format (group schema therapy, GST) has also been developed. GST has been found to speed up and amplify the treatment effects found for individual ST. Delivery in a group format may lead to improved cost-effectiveness. An important question is how GST compares to treatment as usual (TAU) and what format for delivery of schema therapy (format A; intensive group therapy only, or format B; a combination of group and individual therapy) produces the best outcomes.

Methods/Design

An international, multicentre randomized controlled trial (RCT) will be conducted with a minimum of fourteen participating centres. Each centre will recruit multiple cohorts of at least sixteen patients. GST formats as well as the orders in which they are delivered to successive cohorts will be balanced. Within countries that contribute an uneven number of sites, the orders of GST formats will be balanced within a difference of one. The RCT is designed to include a minimum of 448 patients with BPD. The primary clinical outcome measure will be BPD severity. Secondary clinical outcome measures will include measures of BPD and general psychiatric symptoms, schemas and schema modes, social functioning and quality of life. Furthermore, an economic evaluation that consists of cost-effectiveness and cost-utility analyses will be performed using a societal perspective. Lastly, additional investigations will be carried out that include an assessment of the integrity of GST, a qualitative study on patients’ and therapists’ experiences with GST, and studies on variables that might influence the effectiveness of GST.

Discussion

This trial will compare GST to TAU for patients with BPD as well as two different formats for the delivery of GST. By combining an evaluation of clinical effectiveness, an economic evaluation and additional investigations, it will contribute to an evidence-based understanding of which treatment should be offered to patients with BPD from clinical, economic, and stakeholders’ perspectives.

Trial registration

Netherlands Trial Register NTR2392 webcite. Registered 25 June 2010.

【 授权许可】

   
2014 Wetzelaer et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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