Implementation of outpatient schema therapy for borderline personality disorder: study design

ABSTRACT: BACKGROUND: Schema Therapy (ST) is an integrative psychotherapy based upon a cognitive schema model which aims at identifying and changing dysfunctional schemas and modes through cognitive, experiential and behavioral pathways. It is specifically developed for patients with personality disorders. Its effectiveness and efficiency have been demonstrated in a few randomized controlled trials, but ST has not been evaluated in regular mental healthcare settings. This paper describes the study protocol of a multisite randomized 2-group design, aimed at evaluating the implementation of outpatient schema therapy for patients with borderline personality disorder (BPD) in regular mental healthcare and at determining the added value of therapist telephone availability outside office hours in case of crisis. METHODS/DESIGN: Patient outcome measures will be assessed with a semi-structured interview and self-report measures on BPD, therapeutic alliance, quality of life, costs and general psychopathology at baseline, 6, 12, 18 and 36 months. Intention-to-treat analyses will be executed with survival analysis for dichotomous variables, and one-sample t-tests and ANCOVAs for continuous variables with baseline as covariate and condition as between group factor. All tests will be two-tailed with a significance level of 5%. DISCUSSION: The study will provide an answer to the question whether ST can be effectively implemented and whether phone support by the therapist has an additional value. TRIAL REGISTRATION: The Dutch Cochrane Center, NTR (TC = 1781

Gender differences in the use of cardiovascular interventions in HIV-positive persons; the D:A:D Study

Peer reviewe

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

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

Optimizing psychotherapy dosage for comorbid depression and personality disorders (PsyDos): Apragmatic randomized factorial trial using schema therapy and short-term psychodynamic psychotherapy

Background: Patients with comorbid depression and personality disorders suffer from a heavy disease burden while tailored treatment options are limited, accounting for a high psychological and economic burden. Little is known about the effect of treatment dosage and type of psychotherapy for this specific co-morbid patient population, in terms of treatment-effect and cost-effectiveness. This study aims to compare treatment outcome of 25 versus 50 individual therapy sessions in a year. We expect the 50-session condition to be more effective in treating depression and maintaining the effect. Secondary objectives will be addressed in order to find therapy-specific and non-specific mechanisms of change. Methods: In a mono-center pragmatic randomized controlled trial with a 2×2 factorial design, 200 patients with a depressive disorder and personality disorder(s) will be included. Patients will be recruited from a Dutch mental health care institute for personality disorders. They will be randomized over therapy dosage (25 vs 50 sessions in a year) and type of therapy (schema therapy vs short-term psychodynamic supportive psychotherapy). The primary clinical outcome measure will be depression severity and remission. Changes in personality functioning and quality of life will be investigated as secondary outcomes. A priori postulated effect moderators and mediators will be collected as well. All patients are assessed at baseline and at 1, 2, 3, 6, 9-12months (end of therapy) and at follow up (6 and 12months after end of treatment). Alongside the trial, an economic evaluation will be conducted. Costs will be collected from a societal perspective. Discussion: This trial will be the first to compare two psychotherapy dosages in patients with both depression and personality disorders. Insight in the effect of treatment dosage for this patient group will contribute to both higher treatment effectiveness and lower costs. In addition, this study will contribute to the limited evidence base on treating patients with both depression and personality disorders. Understanding the processes that account for the therapeutic changes could help to gain insight in what works for whom. Trial registration: This trial has been registered on July 20th 2016, Netherlands Trial Register, part of the Dutch Cochrane Centre ( NTR5941 )