Innovations Received: April 27, 2015 Accepted after revision: October 16, 2015 Published online: January 26, 2016
Psychother Psychosom 2016;85:71–80 DOI: 10.1159/000441731
Psychoanalytic-Interactional Therapy versus Psychodynamic Therapy by Experts for Personality Disorders: A Randomized Controlled Efficacy-Effectiveness Study in Cluster B Personality Disorders Falk Leichsenring a Oliver Masuhr b Ulrich Jaeger b Sven Rabung c, d Andreas Dally b Michael Dümpelmann b Christian Fricke-Neef b Christiane Steinert a Ulrich Streeck b
a
Department of Psychsomatics and Psychotherapy, University of Giessen, Giessen, b Asklepios Clinic Tiefenbrunn, Rosdorf, and c Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; d Department of Psychology, Alpen-Adria-Universität Klagenfurt, Klagenfurt, Austria
Abstract Background: With regard to cluster B personality disorders, most psychotherapeutic treatments focus on borderline personality disorder. Evidence-based treatments for patients with other cluster B personality disorders are not yet available. Psychoanalytic-interactional therapy (PIT) represents a transdiagnostic treatment for severe personality disorders. PIT has been applied in clinical practice for many years and has proven effective in open studies. In a randomized controlled trial, we compared manual-guided PIT to nonmanualized pychodynamic therapy by experts in personality disorders (E-PDT) in patients with cluster B personality disorders. Methods: In an inpatient setting, patients with
© 2016 S. Karger AG, Basel 0033–3190/16/0852–0071$39.50/0 E-Mail [email protected] www.karger.com/pps
cluster B personality disorders were randomly assigned to manual-guided PIT (n = 64) or nonmanualized E-PDT (n = 58). In addition, a quasi-experimental control condition was used (n = 46) including both patients receiving treatment as usual and patients waiting for treatment. Primary outcomes were level of personality organization and overall psychological distress. As secondary outcomes, depression, anxiety and interpersonal problems were examined. Results: No significant improvements were found in the control patients. Both PIT and E-PDT achieved significant improvements in all outcome measures and were superior to the control condition. No differences were found between PIT and E-PDT in any outcome measure at the end of treatment. The type of cluster B personality disorder had no impact on the results.
The study was in part supported by a grant from the Heigl-Stiftung. The study is registered at the German Clinical Trials Register (No. DRKS00000068).
Prof. Dr. Falk Leichsenring Department of Psychosomatics and Psychotherapy, University of Giessen Ludwigstrasse 76 DE–35392 Giessen (Germany) E-Mail Falk.Leichsenring @ psycho.med.uni-giessen.de
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Key Words Cluster B personality disorders · Psychoanalytic-interactional therapy · Psychodynamic therapy
© 2016 S. Karger AG, Basel
Introduction
Cluster B personality disorders encompass a group of severe personality disorders, including borderline personality disorder (BPD), narcissistic personality disorder (NPD), histrionic personality disorder (HPD), and antisocial personality disorder (APD) [1]. Whereas research on BPD has considerably increased during recent years [2], research on other cluster B personality disorders is relatively scarce [3]. No manual-guided methods of psychotherapy have been developed for NPD or HPD, neither on a psychodynamic nor on a cognitive behavioral basis. For APD, a few approaches exist. Mentalizationbased therapy, which was shown to be efficacious in BPD, has been adapted to the treatment of APD [4]. Studies, however, are not yet available. In two randomized controlled trials (RCTs), cognitive behavioral approaches were applied in violent men with APD or in opioid-dependent patients with APD [5–7]. Moreover, some RCTs included APD as comorbid disorders in patients with substance abuse and evaluated the impact of APD on outcome [8, 9]. A recent Cochrane review on pharmacological interventions for APD reported that no RCT could be identified that set out to recruit participants solely on the basis of having APD [10]. Cochrane reviews for both psychotherapy and pharmacotherapy in HPD were recently withdrawn since the authors could not identify potentially suitable studies [11, 12]. Treatment studies on NPD are also nonexistent [3, 13]. With regard to cluster B personality disorders as a group, a more recent RCT found no significant differences in direct comparisons between dialectical behavior therapy and treatment as usual (TAU) [14]. In three quasi-experimental studies, the effectiveness of different levels of care in the treatment of patients with clusters A, B, and C were studied [15–17]. Selfharming patients with cluster B personality disorders were shown to benefit more from a step-down program than from long-term inpatient treatment [18]. Overall, further RCTs of psychotherapy or pharmacotherapy for cluster B personality disorders are required. Psychoanalytic-interactional therapy (PIT) has been specifically developed for the treatment of more severe 72
Psychother Psychosom 2016;85:71–80 DOI: 10.1159/000441731
mental disorders, including severe personality disorders (e.g. BPD, NPD, and HPD), as well as substance abuse disorders [19, 20]. Manuals describing the approach in detail are available [19]. In Germany, PIT is frequently used in clinical practice [19]. To test the efficacy of PIT, we carried out an RCT in inpatients with cluster B personality disorders comparing PIT to psychodynamic therapy carried out by experts (E-PDT). In order to control for both the natural course of the disorders and unspecific factors of psychotherapy, we additionally included a quasi-experimental control condition [21], i.e. a control condition for which comparability to the treatment conditions is not achieved by randomization, but by demonstrating comparability with regard to relevant and measured variables that potentially affect outcome [21].
Objectives
In nonmanual-guided psychodynamic therapy, even if carried out by experts in personality disorders (E-PDT), the treatment is tailored to the patients in the usual clinical way. In manual-guided PIT, this is done more systematically using specific therapeutic techniques [19]. Previous clinical experiences showed that PIT is superior to E-PDT. Thus, we hypothesized that (1) both PIT and EPDT would be superior to the control condition, and (2) PIT would be superior to E-PDT. Methods Study Design and Implementation The study was carried out at the Asklepios Clinic Tiefenbrunn in Germany. Patients were admitted for inpatient treatment if they were too severely disturbed for an outpatient treatment including 1 or 2 sessions a week. Patients were recruited from October 2008 to July 2012. The study protocol was approved by the responsible ethics committee and was conducted in accordance with the guidelines for good clinical practice. Patients who applied for treatment and who had been given the presumptive diagnosis of a cluster B personality disorder by the referring clinician were asked to participate in the study. Seventy-six patients were immediately admitted to the hospital and randomly assigned to PIT or E-PDT (fig. 1). As it was not possible to admit all possibly eligible patients to the clinic immediately, we were able to establish a (quasi-experimental) control condition – no randomization procedures were applied here. In the control condition, some patients continued their usual treatment (TAU), while others waited for treatment without receiving any therapy. Thus, the control condition was in fact a mixed condition. Assignment to the control condition depended on the clinic’s capacity to admit a new patient. In order to gain baseline scores of these patients, the battery of self-
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Conclusions: In an inpatient setting, both PIT and E-PDT proved to be superior to a control condition in cluster B personality disorders. In a head-to-head comparison, both treatments appeared to be equally effective. Further research on the treatment of cluster B personality disorders is required.
n = 518 Patients with suspected cluster B personality n = 35 Refusal of participation n = 146 Cancellation/no show at admission n = 208 No confirmation of cluster B personality disorder n=7 No assessment at admission n = 122 Intent to treat
n = 76 Immediate treatment group
n = 46 Quasi-experimental control group
n = 44 Randomized without waiting to PIT
n = 20
Randomized from waiting list to PIT
+
n = 32 Randomized without waiting to E-PDT
n = 26
Randomized from waiting list to E-PDT
+
n = 64 PIT
n = 58 E-PDT
- 7 incomplete data records - 7 therapy called off - 3 disciplinary discharges - 2 transfers
- 9 incomplete data records - 8 therapy called off - 1 disciplinary discharge - 1 transfer
report questionnaires used in this study was sent by mail to all patients on the control condition. In the 108 controls, the Structured Clinical Interview for DSM-IV (SCID II) was performed after the waiting/TAU period at admission to the hospital [22]. Forty-six patients fulfilling the inclusion criteria for a cluster B personality disorder were then randomly assigned to either PIT or E-PDT (fig. 1). Of the 46 controls, 20 subjects were later randomized to PIT and 26 to E-PDT (see below). In order to avoid dependent measurement, these 20 and 26 patients were not included in the statistical comparison of PIT/E-PDT with the controls (see below, also fig. 1).
Subjects The following inclusion criteria were applied: age between 18 and 65 years and a diagnosis of a cluster B personality disorder according to SCID II [22]. The following conditions were excluded: psychotic and acute substance-related disorders, acute (uncontrollable) risk of suicide, organic mental disorders, and severe medical conditions (according to ICD-10) [23]. Providing informed consent was required for inclusion. 518 patients with the presumptive diagnosis of a cluster B personality disorder applying for inpatient treatment were screened (fig. 1). 122 patients with the diagnosis of a cluster B personality disorder were included in the study. Sixty-
PIT vs. E-PDT
Psychother Psychosom 2016;85:71–80 DOI: 10.1159/000441731
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Fig. 1. Flow chart.
Assessment For the control condition, assessments were conducted at the beginning of the waiting/TAU period, at the end of the waiting/ TAU period (identical to the assessment at admission), and at discharge (after treatment). For patients immediately admitted and randomized to treatment, assessments took place at admission and at discharge. Axis II diagnoses were made by use of SCID II [22]. Seven specifically trained and independent assessors conducted the interviews. In addition, ICD-10 (axis I) diagnoses were given by trained raters using the research diagnostic criteria of ICD-10 to ensure reliability [23]. As primary outcome measures, two selfreport instruments were used, the Borderline Personality Inventory (BPI) and the Symptom Check List SCL-90-R [24–26]. The 52-item BPI taps the level of personality organization according to Kernberg [26, 27]. Besides a total score, the BPI also provides subscales for identity diffusion, primitive defense mechanisms/object relations, and reality testing [26]. General symptom distress was assessed by use of the Global Severity Index (GSI) of the SCL-90-R [24, 25]. Secondary outcome measures included the Beck Anxiety Inventory (BAI), the Beck Depression Inventory (BDI), and the Inventory of Interpersonal Problems (IIP) [28–30]. Randomization Patients fulfilling the inclusion criteria were randomized to either PIT or E-PDT by use of a computer-generated randomization list generated by two of the authors (U.J., O.M.). Randomization was stratified for sex. Statistical Analyses With regard to the primary outcome measures (BPI, GSI), we aimed to detect a medium effect size (d = 0.50) between PIT and E-PDT in favor of PIT with a power of 0.80. For this purpose, 2 × 51 patients are required at a level of significance of α = 0.05 using 1-sided tests [31]. For the primary outcome measures, type I error probability was not adjusted since it refers to different psychological concepts (level of personality organization vs. symptom distress) [32]. For the three secondary outcome measures (BDI, BAI, and IIP) α was adjusted (0.02 = 0.05/3). Comparisons between groups with regard to outcome were performed for posttherapy data by general linear effect models including the baseline scores of the respective outcome measure as a covariate. For intentionto-treat analysis, we applied multiple imputation by chained equations to account for the uncertainty resulting from missing outcomes [33, 34]. To generate conservative estimates, 50 imputations were created and all available variables were included in the imputation process. Multiple imputation of missing data was conducted by use of IBM SPSS Statistics 20.0 (IBM Corp. 2011). Data analysis was carried out by use of SAS 9.3 (SAS Institute). Treatments Psychoanalytic-Interactional Therapy The interventions used in PIT are described in treatment manuals [19, 20, 35]. The main principle of intervention used in PIT is called the ‘responsive mode’. The responsive mode characterizes the therapist’s technical attitude: he presents himself as ‘another (feeling) person’ in a dyadic interaction. Instead of interpreting the
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patient’s behavior, he selectively verbalizes the effects that the patient's behavior has on him. After psychotherapeutic reflection the therapist selectively allows the patient to participate in the experiences and feelings that he perceives in himself as a reaction to the behavior presented by the patient either to him or to another person (e.g. ‘I am feeling misunderstood when you attack me in this way’ or ‘I am wondering whether this woman felt embarrassed by the way you behaved towards her’). In PIT, selective self-disclosure is neither employed spontaneously nor does it aim at making the therapeutic dialogue more egalitarian. The therapist in PIT needs to decide if any and which aspects of his countertransference may be beneficial for making the patient’s interpersonal world more transparent. The responsive mode fosters the development of several psychosocial functions, such as differentiating between self and object, or realizing the effects of one’s own behavior on others. They also show that the therapist is able to protect his own boundaries, thus many severely disordered patients are relieved from their overpowering fear of the strength of their impulses [36]. In contrast to transference-focused therapy [37], PIT does not make use of interpretations, but uses the responsive mode as described above. Compared to mentalization-based therapy [38], behavior and feelings are not attributed to motives or other characteristics of the individual person, but to the interactional context in which these behaviors and feelings occur. The principle type of intervention that discriminates PIT from mentalization-based therapy is the use of the responsive mode. Psychodynamic Therapy by Experts in Personality Disorders In the comparison condition, the treatment followed the principles of psychodynamic therapy as described by Gabbard [39], with the interventions situated on an interpretive-supportive continuum [39, 40]. In contrast to PIT, however, no specific treatment manual was used. The treatment was specifically tailored to the individual patient’s needs by the treating clinicians. As the psychopathology of cluster B personality disorders is based on impairments in ego functions rather than on unconscious conflicts, EPDT primarily made use of interventions aiming to maintain or build ego functions [40], e.g. impulse control in BPD, affect regulation in HPD, or regulation of self-esteem in NPD. Thus, a major focus was on the regulation of the self (e.g. self-esteem or integrating split self-representations), object relationships (e.g. differentiating between self and others, integrating split object representations), and affects (e.g. impulse control) [41, 42]. We initially considered calling this condition psychodynamic treatment as usual, but this term does not do justice to the actual treatment for several reasons. First, this treatment is ‘usual’ to the treatment of severe personality disorders at the Tiefenbrunn Clinic, which has been highly specialized in the treatment of severe personality disorders for many years [43], but it is not necessarily usual for a treatment in another clinic or even in another country. Second, the treatment was specifically tailored to the foci relevant to cluster B personality disorders described above by the treating clinicians. Finally, the therapists were familiar with the treatment of severe personality disorders and received continuous supervision by a highly experienced therapist (M.D.). For this reason, the treatment can best be described as nonmanual-guided PDT delivered by experts in personality disorders (E-PDT). As part of the inpatient treatment, PIT and E-PDT were applied in both an individual and a group setting, with 1 or 2 sessions per week in individual therapy and 3 sessions per week in group ther-
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four patients were randomly assigned to PIT and 58 patients to E-PDT. The control condition included 46 patients: 20 of these patients were later randomized to PIT and 26 to E-PDT (fig. 1).
Age, years Females APD1 BPD1 HPD1 NPD1
PIT (n = 64)
E-PDT (n = 58)
WL/TAU (n = 46)
28.63 ± 8.71 44 (69) 6 (9) 50 (78) 0 (0) 17 (27)
30.43 ± 9.05 40 (69) 8 (14) 51 (88) 2 (3) 11 (19)
30.72 ± 9.42 32 (70) 7 (15) 39 (85) 1 (2) 10 (22)
Values are presented as means ± SD or n (%). None of the differences between the groups was statistically significant. 1 Multiple diagnoses possible.
apy. All patients additionally received art therapy or body therapy (1 or 2 sessions per week), and consultations with a social worker if needed. In cases of severe symptoms of depression or anxiety, additional pharmacotherapy was given temporarily.
Results
Patient characteristics are detailed in table 1. Patients were predominantly female (84/122 = 69%). The mean age was 28.63 (SD = 8.71) for PIT, 30.43 (SD = 9.05) for E-PDT, and 30.72 (SD = 9.42) for the controls. BPD was diagnosed in 101 patients (83%), APD in 14 patients (11%), HPD in 2 patients (2%), and NPD in 28 patients (23%) by use of SCID II. Multiple diagnoses for cluster B personality disorders were possible. The mean number of cluster B personality diagnoses was 1.19 (SD = 0.49). The mean number of axis I diagnoses according to ICD-10 [23] was 2.86 (SD = 1.02). Controls During the waiting/TAU period, 37 of the 46 patients (80%) continued their usual treatment (psychotherapy with or without medication). Mean TAU/waiting time was 90 days (mean = 89.69, SD = 105.31). Thus, it was comparable to treatment duration (see below). In the control condition, the distribution of cluster B personality disorders was very similar to that in PIT and PDT-E (table 1). With regard to their baseline data, the 46 controls did not differ significantly from the 76 patients (44 + 32) treated immediately with PIT or E-PDT in any outcome measure (MANOVA: Wilks’ Lambda = 0.91, F = 1.07, d.f. 9, 100, p = 0.39). Thus, for baseline data, the control patients were comparable to the patients immediately treated with PIT or E-PDT. PIT vs. E-PDT
Therapists PIT was carried out by 13 therapists specifically supervised and trained in PIT. E-PDT was carried out by 13 experienced therapists who received the same amount of training and general clinical supervision. No therapist carried out both PIT and E-PDT. The therapists in the PIT group had an average clinical experience of 5.14 years (SD = 4.45), while the therapists in the E-PDT group had an average of 2.77 years (SD = 4.04). The difference was not significant (p = 0.16). Treatment Integrity Therapists applying PIT were specifically trained in this approach by one of its developers (U.S.). Using videotaped treatment sessions, therapists were continuously supervised by highly experienced therapists who contributed to the development of PIT. In order to examine treatment integrity, videotapes of 30 randomly selected individual treatment sessions were studied: 15 of PIT and 15 of E-PDT. A checklist including the key interventions of PIT was used for this purpose. Two independent masked raters were trained in both PIT and the use of the checklist by one of the developers of PIT (U.S.). They independently rated the 30 videotapes. Having seen the videos, they rated (1) whether PIT or E-PDT was applied and (2) the overall therapist’s competence in applying principles of PIT. For the latter, a 4-point Likert rating scale was used comparable to the overall competence rating scale of the Penn Adherence and Competence Scale [44]. To a great extent, the two raters identified the treatments correctly. Rater 1 identified 28 of the 30 treatments correctly (93%, phi = 0.86, p < 0.0001), and rater 2 identified all treatments correctly (100%, phi = 1.0, p < 0.0001). The interrater agreement between the raters was phi = 0.87 (p < 0.0001). Therapists applying PIT were rated as significantly more competent in applying PIT than therapists applying E-PDT. The mean rating of the two raters for the competent application of PIT was 2.06 for PIT (SD = 0.31) and 0.92 (SD = 0.46) for E-PDT (t = 7.86, p < 0.0001). According to these results, the two methods of psychotherapy applied here could be sufficiently discriminated by the two masked raters, both on the level of identifying treatments and on the level of competence for applying principles of PIT. Length of Treatment Mean treatment duration was 106.70 days (SD = 41.71) for PIT and 76.78 days (SD = 21.07) for E-PDT. As this difference was statistically significant (p < 0.0001), treatment duration was included as a covariate in the statistical analysis. Psychother Psychosom 2016;85:71–80 DOI: 10.1159/000441731
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Table 1. Description of the sample
Table 2. Outcomes for controls with cluster B personality disorders (intention-to-treat data)
Measure and time of evaluation
Controls (n = 46)
Controls vs. PIT (n = 46 vs. 44), p/d
Controls vs. E-PDT (n = 46 vs. 32), p/d
BPI – Total Score Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
26.70 ± 8.13 26.39 ± 8.32 0.04
0.0043/0.61
0.0004/0.82
BPI – Identity Diffusion Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
6.74 ± 2.61 6.46 ± 2.55 0.11
0.01/0.52
0.0005/0.80
BPI – Primitive Defense Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
5.65 ± 1.87 5.46 ± 1.94 0.10
0.0005/0.73
0.0001/1.91
BPI – Reality Testing Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
0.63 ± 1.05 0.67 ± 1.37 –0.03
0.65/0.10
0.65/0.10
1.77 ± 0.62 1.65 ± 0.69 0.18
0.0001/0.98
0.0001/1.10
BAI Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
25.21 ± 12.10 24.87 ± 13.13 0.03
0.051/0.41
0.056/0.44
BDI Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
30.04 ± 9.98 27.80 ± 10.67 0.22
0.0001/0.86
0.0001/1.02
Symptom Check List SCL90-R GSI Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
Values are presented as means ± SD or d, unless indicated otherwise. p = Error probability; d = Cohen’s d.
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Adverse Events Two patients were transferred to a psychiatric clinic (closed ward) due to an acute risk of suicide, one patient to another clinic due to a critically low BMI. Treatment Effects Comparison of PIT and E-PDT with the Control Patients In the 46 control patients, no significant changes were found in any outcome measure during the waiting or TAU period (p > 0.05, table 2). In these patients, all within-group effect sizes were small (Cohen’s d = –0.03 Leichsenring et al.
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Concomitant Pharmacotherapy In the PIT group, 37.5% received an antidepressive medication (selective serotonin reuptake inhibitors, noradrenalin reuptake inhibitors, or tricyclic antidepressants) as compared with 46.1% in the E-PDT group. The difference was not significant (p = 0.311). This was also true for neuroleptics (50 vs. 60.3%, p = 0.251) and anxiolytics (4.7 vs. 5.2%, p = 0.902). In total, 76% of the PIT patients and 79.3% of the E-PDT patients received temporarily some form of pharmacotherapy (p = 0.715). Thus, the two treatments did not differ with regard to the applied pharmacotherapy.
Table 3. Outcomes for inpatient PIT and E-PDT in patients with cluster B personality disorders (intention-to-
treat data) Measure and time of evaluation
PIT (n = 64)
E-PDT (n = 58)
BPI – Total Score Admission Discharge Within-group effects size, d
22.83 ± 8.13 18.76 ± 8.60 0.49
25.55 ± 8.42 19.41 ± 9.38 0.74
0.07
BPI – Identity Diffusion Admission Discharge Within-group effects size, d
5.73 ± 2.63 4.45 ± 2.90 0.48
6.48 ± 2.70 4.28 ± 2.91 0.83
0.21
BPI – Primitive Defense Admission Discharge Within-group effects size, d
4.98 ± 2.17 3.54 ± 2.64 0.71
4.98 ± 1.88 3.32 ± 2.28 0.81
0.02
BPI – Reality Testing Admission Discharge Within-group effects size, d
0.34 ± 0.85 0.47 ± 0.97 –0.12
0.72 ± 1.23 0.66 ± 0.99 0.06
0.10
1.56 ± 0.61 0.99 ± 0.66 0.86
1.56 ± 0.71 0.96 ± 0.76 0.91
0.11
BAI Admission Discharge Within-group effects size, d
21.31 ± 12.17 17.09 ± 13.13 0.33
22.65 ± 13.68 18.04 ± 12.60 0.36
0.03
BDI Admission Discharge Within-group effects size, d
27.95 ± 10.75 17.44 ± 11.88 0.96
24.39 ± 11.21 15.20 ± 11.07 0.84
0.09
IIP Admission Discharge Within-group effects size, d
15.49 ± 3.68 13.21 ± 4.49 0.61
14.96 ± 3.83 11.57 ± 5.37 0.90
0.13
Symptom Check List SCL90-R GSI Admission Discharge Within-group effects size, d
PIT vs. E-PDT (between-group effect size d)1
to 0.22). By including both patients with and without treatment, the improvements occurring during the waiting time can be expected to be higher than in a pure waiting list control condition, but smaller than those in a pure treatment-as-usual condition. Of the 46 controls, 20 subjects were later randomized to PIT and 26 to EPDT. In order to avoid dependent measurement, these
patients were not included in the statistical comparison of PIT/E-PDT with the controls. Thus, 44 patients receiving PIT (64–20) and 32 patients receiving E-PDT (58–26) were compared with the 46 patients in the control condition (fig. 1). By general linear effect models including the baseline scores of the respective outcome measure as a covariate, the 46 controls were compared
PIT vs. E-PDT
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Values are presented as means ± SD or d, unless indicated otherwise. 1 Between-group effect sizes based on GLM-adjusted means.
PIT vs. E-PDT Comparing PIT (n = 64) and E-PDT (n = 58) with regard to the posttherapy data by general linear effect models including the baseline scores of the respective outcome measure and duration of treatment as covariates did not find significant differences between PIT and EPDT in any outcome measure (p > 0.23). In terms of Cohen’s d, all differences corresponded to small betweengroup effect sizes (0.02–0.21, based on GLM-adjusted means, table 3). Including the type of cluster B personality disorder as a covariate in the analyses did not change the results, suggesting no differential effects of PIT and E-PDT for type of cluster B personality disorder. The patients treated with PIT (n = 64) showed significant improvements in all primary (p < 0.001) and secondary measures (p < 0.001, BAI: p = 0.003), except for BPI reality testing (p = 0.06, table 2). This was also true for the 58 patients treated with E-PDT (p < 0.001, BAI: p = 0.01, BPI reality testing: p = 0.59). For the primary outcomes, within-group effect sizes for PIT and E-PDT were between medium to large (d: 0.48–0.91, table 2).
Discussion
In clinical settings, cluster B personality disorders are quite common and associated with high societal costs, low quality of life, and increased disability [2, 45– 47]. In this study, two transdiagnostic psychodynamic treatments for severe personality disorders, PIT and EPDT, were studied. The distribution of the various cluster B personality disorders in the present study with most patients showing BPD and least patients showing 78
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HPD corresponded well to that reported by Bartak et al. [16], except for a smaller percentage of patients with HPD. This distribution also reflects the differences in prevalence found between the different types of cluster B personality disorders [48]. Taken together, we did not find evidence for a differential efficacy of PIT or E-PDT for any type of cluster B personality disorder. PIT and E-PDT seem to be equally efficacious in patients with BPD, NPD, and APD. The number of patients with HPD (n = 2) was too small to allow for reliable conclusions. Svartberg et al. [49] showed PDT to be transdiagnostically efficacious in cluster C personality disorders. According to this study, PIT and E-PDT seem to be transdiagnostically beneficial in cluster B personality disorders. This study does have some limitations. Patients were not randomly assigned to the control condition. Thus, it represents a quasi-experimental control group. Patients in this group, however, were shown not to differ significantly from the patients who received immediate treatment. By a nonrandomized quasi-experimental control condition, however, only known and measured variables can be controlled for. In contrast to PIT and EPDT, no improvements occurred in the controls. Furthermore, a high but well-balanced proportion of patients in PIT and E-PDT received an additional pharmacological treatment. This proportion is comparable to RCTs of psychotherapy in BPD using dialectical behavior therapy, schema-focused therapy or mentalization-based therapy [50–53]. PIT and E-PDT did not differ significantly with regard to concomitant pharmacotherapy. Furthermore, the inpatient setting included a variety of nonspecific ingredients (e.g. art therapy and body therapy). As another limitation, neither observerrated outcomes nor follow-up assessments were included. In this study, established self-report instruments were used as outcome measures. Furthermore, the study was not sufficiently powered to detect small differences between the two active treatments [54]. In terms of Cohen’s d, however, all differences corresponded to small between-group effect sizes (0.02–0.21) whose clinical significance is questionable. On the other hand, our study combines the advantages of an efficacy study with those of an effectiveness study, thus balancing internal and external validity. The lack of differences in outcome between PIT and E-PDT seems to show that manualizing PDT for more severe personality disorders does not significantly affect the outcome. These results are comparable to that reported by Vinnars et al. [55] who did not find differences in Leichsenring et al.
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with the patients treated with either PIT or E-PDT regarding their outcome at the end of the waiting or TAU period versus end of treatment, respectively. According to the results, PIT (n = 44) was significantly superior to the controls (n = 46) in all outcome measures (BPI – Total Score: p = 0.0043; BPI – Primitive Defense: p = 0.0005; BPI – Identity Diffusion: p = 0.01; GSI: p < 0.0001; BDI: p < 0.001) except for anxiety (BAI: p = 0.051) and the reality testing subscale of the BPI (p = 0.37). For the latter, a difference is not to be expected as the scale refers to impairments of reality testing on a psychotic level (hearing voices, etc.). E-PDT (n = 32) achieved the same pattern of results (p < 0.0004, BAI: p = 0.056). When the type of cluster B personality disorder was additionally taken into account as a covariate in the analysis model, results did not change.
outcome between manual-guided supportive expressive therapy and nonmanual-guided community-delivered PDT in outpatients with personality disorders [55]. Further studies examining the effects of PIT and E-PDT in patients with cluster B personality disorders in outpatient
settings are required. Furthermore, it would be interesting to extend the evidence-based methods of psychodynamic psychotherapy for BPD such as mentalizationbased therapy or transference-focused therapy [4, 53] to other cluster B personality disorders.
References
PIT vs. E-PDT
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Psychother Psychosom 2016;85:71–80 DOI: 10.1159/000441731
Psychoanalytic-Interactional Therapy versus Psychodynamic Therapy by Experts for Personality Disorders: A Randomized Controlled Efficacy-Effectiveness Study in Cluster B Personality Disorders Falk Leichsenring a Oliver Masuhr b Ulrich Jaeger b Sven Rabung c, d Andreas Dally b Michael Dümpelmann b Christian Fricke-Neef b Christiane Steinert a Ulrich Streeck b
a
Department of Psychsomatics and Psychotherapy, University of Giessen, Giessen, b Asklepios Clinic Tiefenbrunn, Rosdorf, and c Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; d Department of Psychology, Alpen-Adria-Universität Klagenfurt, Klagenfurt, Austria
Abstract Background: With regard to cluster B personality disorders, most psychotherapeutic treatments focus on borderline personality disorder. Evidence-based treatments for patients with other cluster B personality disorders are not yet available. Psychoanalytic-interactional therapy (PIT) represents a transdiagnostic treatment for severe personality disorders. PIT has been applied in clinical practice for many years and has proven effective in open studies. In a randomized controlled trial, we compared manual-guided PIT to nonmanualized pychodynamic therapy by experts in personality disorders (E-PDT) in patients with cluster B personality disorders. Methods: In an inpatient setting, patients with
© 2016 S. Karger AG, Basel 0033–3190/16/0852–0071$39.50/0 E-Mail [email protected] www.karger.com/pps
cluster B personality disorders were randomly assigned to manual-guided PIT (n = 64) or nonmanualized E-PDT (n = 58). In addition, a quasi-experimental control condition was used (n = 46) including both patients receiving treatment as usual and patients waiting for treatment. Primary outcomes were level of personality organization and overall psychological distress. As secondary outcomes, depression, anxiety and interpersonal problems were examined. Results: No significant improvements were found in the control patients. Both PIT and E-PDT achieved significant improvements in all outcome measures and were superior to the control condition. No differences were found between PIT and E-PDT in any outcome measure at the end of treatment. The type of cluster B personality disorder had no impact on the results.
The study was in part supported by a grant from the Heigl-Stiftung. The study is registered at the German Clinical Trials Register (No. DRKS00000068).
Prof. Dr. Falk Leichsenring Department of Psychosomatics and Psychotherapy, University of Giessen Ludwigstrasse 76 DE–35392 Giessen (Germany) E-Mail Falk.Leichsenring @ psycho.med.uni-giessen.de
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Key Words Cluster B personality disorders · Psychoanalytic-interactional therapy · Psychodynamic therapy
© 2016 S. Karger AG, Basel
Introduction
Cluster B personality disorders encompass a group of severe personality disorders, including borderline personality disorder (BPD), narcissistic personality disorder (NPD), histrionic personality disorder (HPD), and antisocial personality disorder (APD) [1]. Whereas research on BPD has considerably increased during recent years [2], research on other cluster B personality disorders is relatively scarce [3]. No manual-guided methods of psychotherapy have been developed for NPD or HPD, neither on a psychodynamic nor on a cognitive behavioral basis. For APD, a few approaches exist. Mentalizationbased therapy, which was shown to be efficacious in BPD, has been adapted to the treatment of APD [4]. Studies, however, are not yet available. In two randomized controlled trials (RCTs), cognitive behavioral approaches were applied in violent men with APD or in opioid-dependent patients with APD [5–7]. Moreover, some RCTs included APD as comorbid disorders in patients with substance abuse and evaluated the impact of APD on outcome [8, 9]. A recent Cochrane review on pharmacological interventions for APD reported that no RCT could be identified that set out to recruit participants solely on the basis of having APD [10]. Cochrane reviews for both psychotherapy and pharmacotherapy in HPD were recently withdrawn since the authors could not identify potentially suitable studies [11, 12]. Treatment studies on NPD are also nonexistent [3, 13]. With regard to cluster B personality disorders as a group, a more recent RCT found no significant differences in direct comparisons between dialectical behavior therapy and treatment as usual (TAU) [14]. In three quasi-experimental studies, the effectiveness of different levels of care in the treatment of patients with clusters A, B, and C were studied [15–17]. Selfharming patients with cluster B personality disorders were shown to benefit more from a step-down program than from long-term inpatient treatment [18]. Overall, further RCTs of psychotherapy or pharmacotherapy for cluster B personality disorders are required. Psychoanalytic-interactional therapy (PIT) has been specifically developed for the treatment of more severe 72
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mental disorders, including severe personality disorders (e.g. BPD, NPD, and HPD), as well as substance abuse disorders [19, 20]. Manuals describing the approach in detail are available [19]. In Germany, PIT is frequently used in clinical practice [19]. To test the efficacy of PIT, we carried out an RCT in inpatients with cluster B personality disorders comparing PIT to psychodynamic therapy carried out by experts (E-PDT). In order to control for both the natural course of the disorders and unspecific factors of psychotherapy, we additionally included a quasi-experimental control condition [21], i.e. a control condition for which comparability to the treatment conditions is not achieved by randomization, but by demonstrating comparability with regard to relevant and measured variables that potentially affect outcome [21].
Objectives
In nonmanual-guided psychodynamic therapy, even if carried out by experts in personality disorders (E-PDT), the treatment is tailored to the patients in the usual clinical way. In manual-guided PIT, this is done more systematically using specific therapeutic techniques [19]. Previous clinical experiences showed that PIT is superior to E-PDT. Thus, we hypothesized that (1) both PIT and EPDT would be superior to the control condition, and (2) PIT would be superior to E-PDT. Methods Study Design and Implementation The study was carried out at the Asklepios Clinic Tiefenbrunn in Germany. Patients were admitted for inpatient treatment if they were too severely disturbed for an outpatient treatment including 1 or 2 sessions a week. Patients were recruited from October 2008 to July 2012. The study protocol was approved by the responsible ethics committee and was conducted in accordance with the guidelines for good clinical practice. Patients who applied for treatment and who had been given the presumptive diagnosis of a cluster B personality disorder by the referring clinician were asked to participate in the study. Seventy-six patients were immediately admitted to the hospital and randomly assigned to PIT or E-PDT (fig. 1). As it was not possible to admit all possibly eligible patients to the clinic immediately, we were able to establish a (quasi-experimental) control condition – no randomization procedures were applied here. In the control condition, some patients continued their usual treatment (TAU), while others waited for treatment without receiving any therapy. Thus, the control condition was in fact a mixed condition. Assignment to the control condition depended on the clinic’s capacity to admit a new patient. In order to gain baseline scores of these patients, the battery of self-
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Conclusions: In an inpatient setting, both PIT and E-PDT proved to be superior to a control condition in cluster B personality disorders. In a head-to-head comparison, both treatments appeared to be equally effective. Further research on the treatment of cluster B personality disorders is required.
n = 518 Patients with suspected cluster B personality n = 35 Refusal of participation n = 146 Cancellation/no show at admission n = 208 No confirmation of cluster B personality disorder n=7 No assessment at admission n = 122 Intent to treat
n = 76 Immediate treatment group
n = 46 Quasi-experimental control group
n = 44 Randomized without waiting to PIT
n = 20
Randomized from waiting list to PIT
+
n = 32 Randomized without waiting to E-PDT
n = 26
Randomized from waiting list to E-PDT
+
n = 64 PIT
n = 58 E-PDT
- 7 incomplete data records - 7 therapy called off - 3 disciplinary discharges - 2 transfers
- 9 incomplete data records - 8 therapy called off - 1 disciplinary discharge - 1 transfer
report questionnaires used in this study was sent by mail to all patients on the control condition. In the 108 controls, the Structured Clinical Interview for DSM-IV (SCID II) was performed after the waiting/TAU period at admission to the hospital [22]. Forty-six patients fulfilling the inclusion criteria for a cluster B personality disorder were then randomly assigned to either PIT or E-PDT (fig. 1). Of the 46 controls, 20 subjects were later randomized to PIT and 26 to E-PDT (see below). In order to avoid dependent measurement, these 20 and 26 patients were not included in the statistical comparison of PIT/E-PDT with the controls (see below, also fig. 1).
Subjects The following inclusion criteria were applied: age between 18 and 65 years and a diagnosis of a cluster B personality disorder according to SCID II [22]. The following conditions were excluded: psychotic and acute substance-related disorders, acute (uncontrollable) risk of suicide, organic mental disorders, and severe medical conditions (according to ICD-10) [23]. Providing informed consent was required for inclusion. 518 patients with the presumptive diagnosis of a cluster B personality disorder applying for inpatient treatment were screened (fig. 1). 122 patients with the diagnosis of a cluster B personality disorder were included in the study. Sixty-
PIT vs. E-PDT
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Fig. 1. Flow chart.
Assessment For the control condition, assessments were conducted at the beginning of the waiting/TAU period, at the end of the waiting/ TAU period (identical to the assessment at admission), and at discharge (after treatment). For patients immediately admitted and randomized to treatment, assessments took place at admission and at discharge. Axis II diagnoses were made by use of SCID II [22]. Seven specifically trained and independent assessors conducted the interviews. In addition, ICD-10 (axis I) diagnoses were given by trained raters using the research diagnostic criteria of ICD-10 to ensure reliability [23]. As primary outcome measures, two selfreport instruments were used, the Borderline Personality Inventory (BPI) and the Symptom Check List SCL-90-R [24–26]. The 52-item BPI taps the level of personality organization according to Kernberg [26, 27]. Besides a total score, the BPI also provides subscales for identity diffusion, primitive defense mechanisms/object relations, and reality testing [26]. General symptom distress was assessed by use of the Global Severity Index (GSI) of the SCL-90-R [24, 25]. Secondary outcome measures included the Beck Anxiety Inventory (BAI), the Beck Depression Inventory (BDI), and the Inventory of Interpersonal Problems (IIP) [28–30]. Randomization Patients fulfilling the inclusion criteria were randomized to either PIT or E-PDT by use of a computer-generated randomization list generated by two of the authors (U.J., O.M.). Randomization was stratified for sex. Statistical Analyses With regard to the primary outcome measures (BPI, GSI), we aimed to detect a medium effect size (d = 0.50) between PIT and E-PDT in favor of PIT with a power of 0.80. For this purpose, 2 × 51 patients are required at a level of significance of α = 0.05 using 1-sided tests [31]. For the primary outcome measures, type I error probability was not adjusted since it refers to different psychological concepts (level of personality organization vs. symptom distress) [32]. For the three secondary outcome measures (BDI, BAI, and IIP) α was adjusted (0.02 = 0.05/3). Comparisons between groups with regard to outcome were performed for posttherapy data by general linear effect models including the baseline scores of the respective outcome measure as a covariate. For intentionto-treat analysis, we applied multiple imputation by chained equations to account for the uncertainty resulting from missing outcomes [33, 34]. To generate conservative estimates, 50 imputations were created and all available variables were included in the imputation process. Multiple imputation of missing data was conducted by use of IBM SPSS Statistics 20.0 (IBM Corp. 2011). Data analysis was carried out by use of SAS 9.3 (SAS Institute). Treatments Psychoanalytic-Interactional Therapy The interventions used in PIT are described in treatment manuals [19, 20, 35]. The main principle of intervention used in PIT is called the ‘responsive mode’. The responsive mode characterizes the therapist’s technical attitude: he presents himself as ‘another (feeling) person’ in a dyadic interaction. Instead of interpreting the
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patient’s behavior, he selectively verbalizes the effects that the patient's behavior has on him. After psychotherapeutic reflection the therapist selectively allows the patient to participate in the experiences and feelings that he perceives in himself as a reaction to the behavior presented by the patient either to him or to another person (e.g. ‘I am feeling misunderstood when you attack me in this way’ or ‘I am wondering whether this woman felt embarrassed by the way you behaved towards her’). In PIT, selective self-disclosure is neither employed spontaneously nor does it aim at making the therapeutic dialogue more egalitarian. The therapist in PIT needs to decide if any and which aspects of his countertransference may be beneficial for making the patient’s interpersonal world more transparent. The responsive mode fosters the development of several psychosocial functions, such as differentiating between self and object, or realizing the effects of one’s own behavior on others. They also show that the therapist is able to protect his own boundaries, thus many severely disordered patients are relieved from their overpowering fear of the strength of their impulses [36]. In contrast to transference-focused therapy [37], PIT does not make use of interpretations, but uses the responsive mode as described above. Compared to mentalization-based therapy [38], behavior and feelings are not attributed to motives or other characteristics of the individual person, but to the interactional context in which these behaviors and feelings occur. The principle type of intervention that discriminates PIT from mentalization-based therapy is the use of the responsive mode. Psychodynamic Therapy by Experts in Personality Disorders In the comparison condition, the treatment followed the principles of psychodynamic therapy as described by Gabbard [39], with the interventions situated on an interpretive-supportive continuum [39, 40]. In contrast to PIT, however, no specific treatment manual was used. The treatment was specifically tailored to the individual patient’s needs by the treating clinicians. As the psychopathology of cluster B personality disorders is based on impairments in ego functions rather than on unconscious conflicts, EPDT primarily made use of interventions aiming to maintain or build ego functions [40], e.g. impulse control in BPD, affect regulation in HPD, or regulation of self-esteem in NPD. Thus, a major focus was on the regulation of the self (e.g. self-esteem or integrating split self-representations), object relationships (e.g. differentiating between self and others, integrating split object representations), and affects (e.g. impulse control) [41, 42]. We initially considered calling this condition psychodynamic treatment as usual, but this term does not do justice to the actual treatment for several reasons. First, this treatment is ‘usual’ to the treatment of severe personality disorders at the Tiefenbrunn Clinic, which has been highly specialized in the treatment of severe personality disorders for many years [43], but it is not necessarily usual for a treatment in another clinic or even in another country. Second, the treatment was specifically tailored to the foci relevant to cluster B personality disorders described above by the treating clinicians. Finally, the therapists were familiar with the treatment of severe personality disorders and received continuous supervision by a highly experienced therapist (M.D.). For this reason, the treatment can best be described as nonmanual-guided PDT delivered by experts in personality disorders (E-PDT). As part of the inpatient treatment, PIT and E-PDT were applied in both an individual and a group setting, with 1 or 2 sessions per week in individual therapy and 3 sessions per week in group ther-
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four patients were randomly assigned to PIT and 58 patients to E-PDT. The control condition included 46 patients: 20 of these patients were later randomized to PIT and 26 to E-PDT (fig. 1).
Age, years Females APD1 BPD1 HPD1 NPD1
PIT (n = 64)
E-PDT (n = 58)
WL/TAU (n = 46)
28.63 ± 8.71 44 (69) 6 (9) 50 (78) 0 (0) 17 (27)
30.43 ± 9.05 40 (69) 8 (14) 51 (88) 2 (3) 11 (19)
30.72 ± 9.42 32 (70) 7 (15) 39 (85) 1 (2) 10 (22)
Values are presented as means ± SD or n (%). None of the differences between the groups was statistically significant. 1 Multiple diagnoses possible.
apy. All patients additionally received art therapy or body therapy (1 or 2 sessions per week), and consultations with a social worker if needed. In cases of severe symptoms of depression or anxiety, additional pharmacotherapy was given temporarily.
Results
Patient characteristics are detailed in table 1. Patients were predominantly female (84/122 = 69%). The mean age was 28.63 (SD = 8.71) for PIT, 30.43 (SD = 9.05) for E-PDT, and 30.72 (SD = 9.42) for the controls. BPD was diagnosed in 101 patients (83%), APD in 14 patients (11%), HPD in 2 patients (2%), and NPD in 28 patients (23%) by use of SCID II. Multiple diagnoses for cluster B personality disorders were possible. The mean number of cluster B personality diagnoses was 1.19 (SD = 0.49). The mean number of axis I diagnoses according to ICD-10 [23] was 2.86 (SD = 1.02). Controls During the waiting/TAU period, 37 of the 46 patients (80%) continued their usual treatment (psychotherapy with or without medication). Mean TAU/waiting time was 90 days (mean = 89.69, SD = 105.31). Thus, it was comparable to treatment duration (see below). In the control condition, the distribution of cluster B personality disorders was very similar to that in PIT and PDT-E (table 1). With regard to their baseline data, the 46 controls did not differ significantly from the 76 patients (44 + 32) treated immediately with PIT or E-PDT in any outcome measure (MANOVA: Wilks’ Lambda = 0.91, F = 1.07, d.f. 9, 100, p = 0.39). Thus, for baseline data, the control patients were comparable to the patients immediately treated with PIT or E-PDT. PIT vs. E-PDT
Therapists PIT was carried out by 13 therapists specifically supervised and trained in PIT. E-PDT was carried out by 13 experienced therapists who received the same amount of training and general clinical supervision. No therapist carried out both PIT and E-PDT. The therapists in the PIT group had an average clinical experience of 5.14 years (SD = 4.45), while the therapists in the E-PDT group had an average of 2.77 years (SD = 4.04). The difference was not significant (p = 0.16). Treatment Integrity Therapists applying PIT were specifically trained in this approach by one of its developers (U.S.). Using videotaped treatment sessions, therapists were continuously supervised by highly experienced therapists who contributed to the development of PIT. In order to examine treatment integrity, videotapes of 30 randomly selected individual treatment sessions were studied: 15 of PIT and 15 of E-PDT. A checklist including the key interventions of PIT was used for this purpose. Two independent masked raters were trained in both PIT and the use of the checklist by one of the developers of PIT (U.S.). They independently rated the 30 videotapes. Having seen the videos, they rated (1) whether PIT or E-PDT was applied and (2) the overall therapist’s competence in applying principles of PIT. For the latter, a 4-point Likert rating scale was used comparable to the overall competence rating scale of the Penn Adherence and Competence Scale [44]. To a great extent, the two raters identified the treatments correctly. Rater 1 identified 28 of the 30 treatments correctly (93%, phi = 0.86, p < 0.0001), and rater 2 identified all treatments correctly (100%, phi = 1.0, p < 0.0001). The interrater agreement between the raters was phi = 0.87 (p < 0.0001). Therapists applying PIT were rated as significantly more competent in applying PIT than therapists applying E-PDT. The mean rating of the two raters for the competent application of PIT was 2.06 for PIT (SD = 0.31) and 0.92 (SD = 0.46) for E-PDT (t = 7.86, p < 0.0001). According to these results, the two methods of psychotherapy applied here could be sufficiently discriminated by the two masked raters, both on the level of identifying treatments and on the level of competence for applying principles of PIT. Length of Treatment Mean treatment duration was 106.70 days (SD = 41.71) for PIT and 76.78 days (SD = 21.07) for E-PDT. As this difference was statistically significant (p < 0.0001), treatment duration was included as a covariate in the statistical analysis. Psychother Psychosom 2016;85:71–80 DOI: 10.1159/000441731
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Table 1. Description of the sample
Table 2. Outcomes for controls with cluster B personality disorders (intention-to-treat data)
Measure and time of evaluation
Controls (n = 46)
Controls vs. PIT (n = 46 vs. 44), p/d
Controls vs. E-PDT (n = 46 vs. 32), p/d
BPI – Total Score Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
26.70 ± 8.13 26.39 ± 8.32 0.04
0.0043/0.61
0.0004/0.82
BPI – Identity Diffusion Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
6.74 ± 2.61 6.46 ± 2.55 0.11
0.01/0.52
0.0005/0.80
BPI – Primitive Defense Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
5.65 ± 1.87 5.46 ± 1.94 0.10
0.0005/0.73
0.0001/1.91
BPI – Reality Testing Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
0.63 ± 1.05 0.67 ± 1.37 –0.03
0.65/0.10
0.65/0.10
1.77 ± 0.62 1.65 ± 0.69 0.18
0.0001/0.98
0.0001/1.10
BAI Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
25.21 ± 12.10 24.87 ± 13.13 0.03
0.051/0.41
0.056/0.44
BDI Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
30.04 ± 9.98 27.80 ± 10.67 0.22
0.0001/0.86
0.0001/1.02
Symptom Check List SCL90-R GSI Start of waiting/TAU period End of waiting/TAU period Within-group effects size, d
Values are presented as means ± SD or d, unless indicated otherwise. p = Error probability; d = Cohen’s d.
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Adverse Events Two patients were transferred to a psychiatric clinic (closed ward) due to an acute risk of suicide, one patient to another clinic due to a critically low BMI. Treatment Effects Comparison of PIT and E-PDT with the Control Patients In the 46 control patients, no significant changes were found in any outcome measure during the waiting or TAU period (p > 0.05, table 2). In these patients, all within-group effect sizes were small (Cohen’s d = –0.03 Leichsenring et al.
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Concomitant Pharmacotherapy In the PIT group, 37.5% received an antidepressive medication (selective serotonin reuptake inhibitors, noradrenalin reuptake inhibitors, or tricyclic antidepressants) as compared with 46.1% in the E-PDT group. The difference was not significant (p = 0.311). This was also true for neuroleptics (50 vs. 60.3%, p = 0.251) and anxiolytics (4.7 vs. 5.2%, p = 0.902). In total, 76% of the PIT patients and 79.3% of the E-PDT patients received temporarily some form of pharmacotherapy (p = 0.715). Thus, the two treatments did not differ with regard to the applied pharmacotherapy.
Table 3. Outcomes for inpatient PIT and E-PDT in patients with cluster B personality disorders (intention-to-
treat data) Measure and time of evaluation
PIT (n = 64)
E-PDT (n = 58)
BPI – Total Score Admission Discharge Within-group effects size, d
22.83 ± 8.13 18.76 ± 8.60 0.49
25.55 ± 8.42 19.41 ± 9.38 0.74
0.07
BPI – Identity Diffusion Admission Discharge Within-group effects size, d
5.73 ± 2.63 4.45 ± 2.90 0.48
6.48 ± 2.70 4.28 ± 2.91 0.83
0.21
BPI – Primitive Defense Admission Discharge Within-group effects size, d
4.98 ± 2.17 3.54 ± 2.64 0.71
4.98 ± 1.88 3.32 ± 2.28 0.81
0.02
BPI – Reality Testing Admission Discharge Within-group effects size, d
0.34 ± 0.85 0.47 ± 0.97 –0.12
0.72 ± 1.23 0.66 ± 0.99 0.06
0.10
1.56 ± 0.61 0.99 ± 0.66 0.86
1.56 ± 0.71 0.96 ± 0.76 0.91
0.11
BAI Admission Discharge Within-group effects size, d
21.31 ± 12.17 17.09 ± 13.13 0.33
22.65 ± 13.68 18.04 ± 12.60 0.36
0.03
BDI Admission Discharge Within-group effects size, d
27.95 ± 10.75 17.44 ± 11.88 0.96
24.39 ± 11.21 15.20 ± 11.07 0.84
0.09
IIP Admission Discharge Within-group effects size, d
15.49 ± 3.68 13.21 ± 4.49 0.61
14.96 ± 3.83 11.57 ± 5.37 0.90
0.13
Symptom Check List SCL90-R GSI Admission Discharge Within-group effects size, d
PIT vs. E-PDT (between-group effect size d)1
to 0.22). By including both patients with and without treatment, the improvements occurring during the waiting time can be expected to be higher than in a pure waiting list control condition, but smaller than those in a pure treatment-as-usual condition. Of the 46 controls, 20 subjects were later randomized to PIT and 26 to EPDT. In order to avoid dependent measurement, these
patients were not included in the statistical comparison of PIT/E-PDT with the controls. Thus, 44 patients receiving PIT (64–20) and 32 patients receiving E-PDT (58–26) were compared with the 46 patients in the control condition (fig. 1). By general linear effect models including the baseline scores of the respective outcome measure as a covariate, the 46 controls were compared
PIT vs. E-PDT
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Values are presented as means ± SD or d, unless indicated otherwise. 1 Between-group effect sizes based on GLM-adjusted means.
PIT vs. E-PDT Comparing PIT (n = 64) and E-PDT (n = 58) with regard to the posttherapy data by general linear effect models including the baseline scores of the respective outcome measure and duration of treatment as covariates did not find significant differences between PIT and EPDT in any outcome measure (p > 0.23). In terms of Cohen’s d, all differences corresponded to small betweengroup effect sizes (0.02–0.21, based on GLM-adjusted means, table 3). Including the type of cluster B personality disorder as a covariate in the analyses did not change the results, suggesting no differential effects of PIT and E-PDT for type of cluster B personality disorder. The patients treated with PIT (n = 64) showed significant improvements in all primary (p < 0.001) and secondary measures (p < 0.001, BAI: p = 0.003), except for BPI reality testing (p = 0.06, table 2). This was also true for the 58 patients treated with E-PDT (p < 0.001, BAI: p = 0.01, BPI reality testing: p = 0.59). For the primary outcomes, within-group effect sizes for PIT and E-PDT were between medium to large (d: 0.48–0.91, table 2).
Discussion
In clinical settings, cluster B personality disorders are quite common and associated with high societal costs, low quality of life, and increased disability [2, 45– 47]. In this study, two transdiagnostic psychodynamic treatments for severe personality disorders, PIT and EPDT, were studied. The distribution of the various cluster B personality disorders in the present study with most patients showing BPD and least patients showing 78
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HPD corresponded well to that reported by Bartak et al. [16], except for a smaller percentage of patients with HPD. This distribution also reflects the differences in prevalence found between the different types of cluster B personality disorders [48]. Taken together, we did not find evidence for a differential efficacy of PIT or E-PDT for any type of cluster B personality disorder. PIT and E-PDT seem to be equally efficacious in patients with BPD, NPD, and APD. The number of patients with HPD (n = 2) was too small to allow for reliable conclusions. Svartberg et al. [49] showed PDT to be transdiagnostically efficacious in cluster C personality disorders. According to this study, PIT and E-PDT seem to be transdiagnostically beneficial in cluster B personality disorders. This study does have some limitations. Patients were not randomly assigned to the control condition. Thus, it represents a quasi-experimental control group. Patients in this group, however, were shown not to differ significantly from the patients who received immediate treatment. By a nonrandomized quasi-experimental control condition, however, only known and measured variables can be controlled for. In contrast to PIT and EPDT, no improvements occurred in the controls. Furthermore, a high but well-balanced proportion of patients in PIT and E-PDT received an additional pharmacological treatment. This proportion is comparable to RCTs of psychotherapy in BPD using dialectical behavior therapy, schema-focused therapy or mentalization-based therapy [50–53]. PIT and E-PDT did not differ significantly with regard to concomitant pharmacotherapy. Furthermore, the inpatient setting included a variety of nonspecific ingredients (e.g. art therapy and body therapy). As another limitation, neither observerrated outcomes nor follow-up assessments were included. In this study, established self-report instruments were used as outcome measures. Furthermore, the study was not sufficiently powered to detect small differences between the two active treatments [54]. In terms of Cohen’s d, however, all differences corresponded to small between-group effect sizes (0.02–0.21) whose clinical significance is questionable. On the other hand, our study combines the advantages of an efficacy study with those of an effectiveness study, thus balancing internal and external validity. The lack of differences in outcome between PIT and E-PDT seems to show that manualizing PDT for more severe personality disorders does not significantly affect the outcome. These results are comparable to that reported by Vinnars et al. [55] who did not find differences in Leichsenring et al.
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with the patients treated with either PIT or E-PDT regarding their outcome at the end of the waiting or TAU period versus end of treatment, respectively. According to the results, PIT (n = 44) was significantly superior to the controls (n = 46) in all outcome measures (BPI – Total Score: p = 0.0043; BPI – Primitive Defense: p = 0.0005; BPI – Identity Diffusion: p = 0.01; GSI: p < 0.0001; BDI: p < 0.001) except for anxiety (BAI: p = 0.051) and the reality testing subscale of the BPI (p = 0.37). For the latter, a difference is not to be expected as the scale refers to impairments of reality testing on a psychotic level (hearing voices, etc.). E-PDT (n = 32) achieved the same pattern of results (p < 0.0004, BAI: p = 0.056). When the type of cluster B personality disorder was additionally taken into account as a covariate in the analysis model, results did not change.
outcome between manual-guided supportive expressive therapy and nonmanual-guided community-delivered PDT in outpatients with personality disorders [55]. Further studies examining the effects of PIT and E-PDT in patients with cluster B personality disorders in outpatient
settings are required. Furthermore, it would be interesting to extend the evidence-based methods of psychodynamic psychotherapy for BPD such as mentalizationbased therapy or transference-focused therapy [4, 53] to other cluster B personality disorders.
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