title: Design of an international multicentre RCT on group schema therapy for borderline personality disorder.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Netherlands Trial Register NTR2392. Registered 25 June 2010.
authors.forename: Pim
authors.initials: P
authors.lastname: Wetzelaer
authors.forename: Joan
authors.initials: J
authors.lastname: Farrell
authors.forename: Silvia M A A
authors.initials: SM
authors.lastname: Evers
authors.forename: Gitta A
authors.initials: GA
authors.lastname: Jacob
authors.forename: Christopher W
authors.initials: CW
authors.lastname: Lee
authors.forename: Odette
authors.initials: O
authors.lastname: Brand
authors.forename: Gerard
authors.initials: G
authors.lastname: van Breukelen
authors.forename: Eva
authors.initials: E
authors.lastname: Fassbinder
authors.forename: Heather
authors.initials: H
authors.lastname: Fretwell
authors.forename: R Patrick
authors.initials: RP
authors.lastname: Harper
authors.forename: Anna
authors.initials: A
authors.lastname: Lavender
authors.forename: George
authors.initials: G
authors.lastname: Lockwood
authors.forename: Ioannis A
authors.initials: IA
authors.lastname: Malogiannis
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schweiger
authors.forename: Helen
authors.initials: H
authors.lastname: Startup
authors.forename: Teresa
authors.initials: T
authors.lastname: Stevenson
authors.forename: Gerhard
authors.initials: G
authors.lastname: Zarbock
authors.forename: Arnoud
authors.initials: A
authors.lastname: Arntz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001315:Australia; D001883:Borderline Personality Disorder / Q000191:economics / Q000523:psychology / Q000628:therapy*; D003362:Cost-Benefit Analysis; D005260:Female; D005858:Germany; D006115:Greece; D006801:Humans; D038622:Internationality; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D011615:Psychotherapy, Group / Q000191:economics / Q000379:methods*; D011788:Quality of Life; D012107:Research Design; D006113:United Kingdom; D014481:United States; D055815:Young Adult