Design of a multicentered randomized controlled trial on the clinical and cost effectiveness of schema therapy for personality disorders

Abstract

BackgroundDespite international guidelines describing psychotherapy as first choice for people with personality disorders (PDs), well-designed research on the effectiveness and cost-effectiveness of psychotherapy for PD is scarce. Schema therapy (ST) is a specific form of psychological treatment that proved to be effective for borderline PD. Randomized controlled studies on the effectiveness of ST for other PDs are lacking. Another not yet tested new specialized treatment is Clarification Oriented Psychotherapy (COP). The aim of this project is to perform an effectiveness study as well as an economic evaluation study (cost effectiveness as well as cost-utility) comparing ST versus COP versus treatment as usual (TAU). In this study, we focus on avoidant, dependent, obsessive-compulsive, paranoid, histrionic and narcissistic PD.Methods/DesignIn a multicentered randomized controlled trial, ST, and COP as an extra experimental condition, are compared to TAU. Minimal 300 patients are recruited in 12 mental health institutes throughout the Netherlands, and receive an extensive screening prior to enrolment in the study. When eligible, they are randomly assigned to one of the intervention groups. An economic evaluation and a qualitative research study on patient and therapist perspectives on ST are embedded in this trial. Outcome assessments (both for clinical effectiveness and economic evaluation) take place at 6,12,18,24 and 36 months after start of treatment. Primary outcome is recovery from PD; secondary measures include general psychopathological complaints, social functioning and quality of life. Data for the cost-effectiveness and cost-utility analyses are collected by using a retrospective cost interview. Information on patient and therapist perspectives is gathered using in-depth interviews and focus groups, and focuses on possible helpful and impeding aspects of ST.DiscussionThis trial is the first to compare ST and COP head-to-head with TAU for people with a cluster C, paranoid, histrionic and/or narcissistic PD. By combining clinical effectiveness data with an economic evaluation and with direct information from primary stakeholders, this trial offers a complete and thorough view on ST as a contribution to the improvement of treatment for this PD patient group.Trial registrationNetherlands Trial Register (NTR): NTR566

The impact of comorbid depression on recovery from personality disorders and improvements in psychosocial functioning: Results from a randomized controlled trial

“…The effects of depression on outcome in personality disorders should therefore be studied in randomized controlled trials (RCT) where patients are randomized to treatment conditions regardless of depression comorbidity. Therefore, the aim of this study was to determine the impact of comorbid depression on recovery from personality disorders and improvements in psychosocial functioning in patients with personality disorders participating in an RCT (Bamelis, Evers, & Arntz, 2012). To the best of our knowledge, the current study is the first to determine the impact of comorbid depression on outcome in the treatment of personality disorders in an RCT.…”

“…A more detailed description of the design, methods, and interventions of this study is available elsewhere (Bamelis et al, 2012). In this study 323 patients with a primary diagnosis of a DSM-IV cluster-c (92%), histrionic, narcissistic or paranoid personality disorder were randomized to a 50 session protocol of schema therapy (n ¼ 147; Arntz, 2012), treatment-as-usual (n ¼ 135), or clarification-oriented psychotherapy (n ¼ 41; Sachse, 2001).…”

“…A more detailed description of the instruments used in the study and their psychometric properties is available elsewhere (Bamelis et al, 2012).…”

“…Both ST and COP therapists were trained at the start of the study during a 4-day training, received supervision once a year and weekly peer-supervision. ST therapists were trained in two cohorts, one receiving mainly lectures and video demonstrations and one participating in active role-plays and receiving individual feedback (Bamelis et al, 2012). Treatment-as-usual (TAU) consisted of whatever treatment the local intake staff indicated (except for ST or COP), following the Dutch clinical guidelines for treating patients with personality disorders.…”

Possible Negative Effects of Psychotherapies

“…Bu çalışmalar bireysel psikoterapi ekollerinin çeşitli psikolojik durumlarda sınanması ve birbirleriyle karşılaştı-rılmasıyla ilişkili olabildiği gibi, grup psikoterapileri ve ekollerden bağımsız olarak çeşitli psikoterapötik tekniklerin etkinlik ve etkililiğine yönelik araştır-malardır. [6][7][8][9][10][11]Bütün bu çalışmalardan elde edilen sonuçların derlendiği ve değerlendirildiği meta analitik çalışmalara da rastlamak mümkündür. [12][13][14][15] A Bu konudaki geniş yazın alan incelendiğinde ilk göze çarpan nokta psikoterapinin genel anlamıyla, pek çok durum için etkili bir tedavi olduğu-dur.…”