Implementation of outpatient schema therapy for borderline personality disorder with versus without crisis support by the therapist outside office hours: A randomized trial
Introduction
Borderline Personality Disorder (BPD) has long been viewed as severe and difficult to treat. However, during recent years several promising treatment possibilities have been developed. Among them, Schema Therapy (ST) was found to be effective regarding all aspects of BPD. How well ST can be delivered in regular mental healthcare practice is unknown, but it was expected that its implementation poses challenges. BPD is marked by chronic instability in multiple areas (emotional dysregulation, self-harm, impulsivity and identity disturbance). The lifetime prevalence of BPD in the general population is 2%. In psychiatric outpatient settings 10% of the patients suffer from BPD, in psychiatric inpatients settings 20% (APA, 2005). The medical and societal costs for BPD are substantial (Ten Have et al., 1995, Van Asselt et al., 2008, Van Asselt et al., 2007). About 10% of the BPD patients die because of suicide (Paris, 1993, Paris, 2008).
However, recent years showed progress in the development of treatment options (Arntz and van Genderen, 2009, Bateman and Fonagy, 2004, Linehan, 1993a, Linehan, 1993b, van Genderen and Arntz, 2005, Yeomans et al., 2002, Young et al., 2003) that are supported by randomized controlled trials (Bateman and Fonagy, 1999, Giesen-Bloo et al., 2006, Linehan et al., 1991, Linehan et al., 2006, Paris, 2008, Verheul et al., 2003). These treatments demonstrated effectiveness on symptom level, as manifested by reduced suicide attempts, fewer acts of self-harm or hospitalizations. In an RCT which compared Schema therapy (ST; also called Schema Focused Therapy (SFT)) and Transference Focused Psychotherapy (TFP) (Giesen-Bloo et al., 2006) both therapies showed a significant change in personality that was maintained at 1-year follow up (Giesen-Bloo et al., 2009). This study showed that three years of ST and TFP proved to bring about a significant change in patient's personality, shown by reductions in all BPD symptoms and general psychopathologic dysfunction, increases in quality of life, and changes in associated personality features. While both treatment conditions showed positive results in the treatment of many aspects of BPD, ST was superior to TFP with respect to reduction in BPD manifestations, general psychopathologic dysfunction, and change in ST/TFP personality concepts. ST had a recovery rate of 45.5% and a reliable change rate of 65.9%. The dropout rate for ST was significantly lower than for TFP.
Based on these positive results, a study of the implementation of ST in regular mental healthcare practice was conducted. One of the premises in the therapeutic approach of ST (Arntz and van Genderen, 2009, van Genderen and Arntz, 2005, Young et al., 2003) and Dialectical Behavior Therapy (Linehan, 1993a, Linehan, 1993b, Linehan et al., 1991, Linehan et al., 2006, Verheul et al., 2003) is that borderline patients need extra support from the therapist between sessions when they are in crisis or in emotional need. For this reason patients are offered a special phone number where they can reach their therapist outside of office hours. This personal connection between sessions is suggested to help to refute the patient's beliefs that there is nobody who really cares and can help to prevent or overcome crisis. In a pilot study of ST crisis support in the form of therapist phone accessibility outside office hours was one of the most controversial topics (Giesen-Bloo, Arntz, Dyck, Spinhoven, & van Tilburg, 2001) and led some therapists to withdraw from the project. In general mental healthcare there is much discussion about this topic because of the financial consequences, the burden to and responsibility of the therapist, and the possible risk of violation of boundaries. Therefore, telephone accessibility outside office hours was perceived as an important barrier for the successful implementation of ST in regular practice. The RCT by Giesen-Bloo et al. (2006) demonstrated that ST is a successful treatment, but it remains unknown whether the crisis support by the therapist was crucial to outcomes. Since the issue of crisis support outside office hours by the therapist makes it difficult to implement ST in regular practice and its effect has never been examined, we decided to investigate the role of the crisis support outside office hours in the implementation study by randomly allocating the crisis support outside office hours to 50% of the therapists.
In sum, this study tested the implementation of ST for BPD in regular mental healthcare and compared two modalities: one with extra crisis support by the therapist outside office hours and one without such telephone support. The study had three aims. First, to assess whether patient outcomes after 1.5 years of ST would be the same when implemented in regular practice, compared to what was found in a clinical trial of this therapy. Since rigorous evaluations such as RCTs always imply controlled conditions, it is unclear to what extent their positive effects can be generalized to regular clinical practice. Treatment effects may be more modest outside RCTs because of different circumstances (Rothwell, 1995, Weersing, 2005, Wilson, 1995). The second aim was to assess the added value of therapist telephone availability outside office hours in case of crisis (TTA) during those 1.5 years of ST. The third aim was to assess the problems that arose during the implementation process.
Section snippets
Study design
The study was a multicenter randomized two-group design for studying the added value of therapist phone support outside office hours. It was also a clinical evaluation of implementing ST for BPD and a comparison of the regular mental healthcare treatment results with a clinical trial, using the so-called benchmark strategy. Benchmarking contains four elements: defining the problem, population and treatment model; selecting or creating a gold-standard outcome benchmark from the research
Analysis
The BPDSI-IV power calculation was based on the aim of showing a difference at the patient level between the conditions with extra phone support of the therapist outside office hours versus the condition without such support. Because we did not know what the effect of the extra phone support might be, it was decided to use a medium effect size of 0.5, according to Cohen (1977), for the power calculation. With a minimum of 2 conditions × 30 patients per condition, the power to demonstrate such a
Sample characteristics
The patient flow is presented in Fig. 1.
Of 92 patients referred to the study centers, 30 patients (32.6% of referrals) were not eligible for participation: 17 patients did not meet the inclusion criteria (either because they had no BPD diagnosis or their BPDSI-IV scores were below 20) and 11 patients met exclusion criteria (1 bipolar disorder, 9 psychotic disorder and 1 ADHD). Another 2 patients were included in the study but could not be randomized because of logistic problems at one of the
Discussion
The present study had several aims. First, to assess the effectiveness of a less intensive form of ST for BPD when implemented in regular health care and compare the results with the originally study by van Giesen-Bloo et al. as a benchmark RCT. Second, to assess whether there was a clinically relevant effect of therapist availability for crisis support outside office hours in the implemented treatment. Third, to describe the impact of the implementation and the problems that emerged during
Funding/support
This research was financially supported by the Health Care Efficiency Research Program: subprogram Implementation (ZonMw) (Grant 945-16-313).
Role of the sponsor
The sponsor played no role in the data collection and analysis, manuscript preparation, or authorization for publication.
Dutch trial registry
NTR: TC = 1781.
Acknowledgements
We wish to acknowledge the contributions of the participating BPD patients, trainers, therapists and research assistants. Furthermore we acknowledge the statistical advice of Adriaan Hoogendoorn, PhD.
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