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The Social Phobia Psychotherapy
The First Multicenter Randomized Controlled Trial of Psychotherapy for Social Phobia:
Rationale, Methods and Patient Characteristics
F. Leichsenring a J. Hoyer b M. Beutel c S. Herpertz d W. Hiller c E. Irle e P. Joraschky b H.H. König f T.M. de Liz g B. Nolting d K. Pöhlmann b S. Salzer e H. Schauenburg h U. Stangier g B. Strauss g C. Subic-Wrana c S. Vormfelde e G. Weniger e U. Willutzki i a University of Giessen, Giessen , b University of Dresden, Dresden, c University of Mainz, Mainz, d University of Dortmund, Dortmund, e University of Göttingen, Göttingen, f University of Leipzig, Leipzig, g University of Jena, Jena, h University of Heidelberg, Heidelberg, i University of Bochum, Bochum, Germany Key Words
(project Q). Study A is complemented by 4 interrelated Social phobia ؒ Cognitive-behavioral therapy ؒ add-on projects focusing on attachment style (study B1), on Psychodynamic psychotherapy ؒ Attachment ؒ Genetics ؒ cost-effectiveness (study B2), on variation in the serotonin transporter gene in SP (study C1) and on structural and func-tional deviations of the hippocampus and amygdala (study C2). Thus, the Social Phobia Psychotherapy Research Net- Abstract
work program enables a highly interdisciplinary research This paper presents the Social Phobia Psychotherapy Re- into SP. The unique sample size achieved by the multicenter search Network. The research program encompasses a coor- approach allows for studies of subgroups (e.g. comorbid dis- dinated group of studies adopting a standard protocol and orders, isolated vs. generalized SP), of responders and non- an agreed-on set of standardized measures for the assess- responders of each treatment approach, for generalization ment and treatment of social phobia (SP). In the central proj- of results and for a sufficient power to detect differences be- ect (study A), a multicenter randomized controlled trial, re- tween treatments. Psychological and biological parameters fined models of manualized cognitive-behavioral therapy will be related to treatment outcome, and variables for dif- and manualized short-term psychodynamic psychotherapy ferential treatment indication will be gained. Thus, the re- are compared in the treatment of SP. A sample of 512 outpa- sults provided by the network may have an important im- tients will be randomized to either cognitive-behavioral pact on the treatment of SP and on the development of therapy, short-term psychodynamic psychotherapy or wait- ing list. Assessments will be made at baseline, at the end of treatment and 6 and 12 months after the end of treatment. For quality assurance and treatment integrity, a specific proj-ect using highly elaborated measures has been established Department of Psychosomatic Medicine and Psychotherapy, University of Giessen Ludwigstrasse 76, DE–35392 Giessen (Germany) Tel. +49 641 994 5660, Fax +49 641 994 5661 E-Mail [email protected] Introduction
Thus, the results provided by the network may have an important impact on the treatment of SP and on the de- In order to fill specific lacks in international psycho- therapy research, the Ministry of Education and Research of Germany has set up a research program 1 . A committee of international experts in psychotherapy research rec- Methods and Description of the Network Projects
ommended the Social Phobia Psychotherapy Research Network (SOPHO-NET) for funding 2 . This article intro- In the following, the research projects presently carried out by the SOPHO-NET will be described. The focus will be on the ran- duces the SOPHO-NET research program 3 .
domized controlled treatment study (study A).
Social phobia (SP) is a frequent, chronic and severely impairing mental disorder [1–4] . Although the available Design of the Multicenter Treatment Study A 5 treatments proved to be beneficial for SP [5–11] , the rates For future studies of SP, experts in the field recommended a of treatment responders are not yet satisfactory [5, 10, 11] . multicenter approach  . Study A is a randomized controlled multicenter study comparing STPP and CBT under equal condi- Furthermore, the neurobiological basis of SP has received tions in the treatment of SP (principal investigator of study A: Dr. only limited investigation [12–14] . Thus, further studies Leichsenring, Giessen). As an additional control condition, a addressing both the efficacy of psychotherapy in SP and waiting list group is included. Five research sites participate in the its neurobiology are required.
trial (Universities of Bochum/Dortmund, Dresden, Göttingen, The research program of the SOPHO-NET 4 encom- Jena and Mainz). In order to ensure a sufficient power, a total of 512 patients will be randomized to 1 of the 3 conditions ( fig. 1 ).
passes a coordinated group of studies adopting a stan-dard protocol and an agreed-on set of standardized mea- Patient Inclusion and Exclusion Criteria sures for the assessment and treatment of SP. In addition The following inclusion criteria are applied: diagnosis of SP to the scientific projects, a specific unit (Q) has been es- (SCID I) and Liebowitz Social Anxiety Scale score 1 30  , as well tablished for project management and quality assurance as age: 18–59 and 60–70 years (allowing to test for effects of age). SP must be the primary diagnosis, i.e. the severest disorder ac- (principal investigator: Dr. Leibing, Göttingen). Q coop- cording to ADIS-IV rating [18, 19] . By including comorbid disor- erates closely with institutions specialized for data man- ders – provided that SP is the severest disorder – a clinically rep- agement and project management. The network includes resentative sample will be gained, allowing to analyze the impact highly interdisciplinary and interrelated research proj- of comorbid disorders on the outcome. A rate of 60% of women ects. For the first time  , manualized cognitive-behav- will be included, reflecting the high prevalence of SP in women  . The following conditions are excluded from the trial: psy- ioral therapy (CBT) and manualized short-term psycho- chotic disorders, prominent risk of self-harm, acute substance- dynamic psychotherapy (STPP) are compared in a large- related disorders, personality disorders except for avoidant, ob- scale multicenter study of SP (study A). By highly sessive-compulsive or dependent personality disorder (as assessed elaborated measures, investigator allegiance effects are by SCID-II); organic mental disorder; severe medical conditions; controlled for (see below). The unique sample size (n = concurrent psychotherapeutic or psychopharmacological treat- 512) achieved by the multicenter approach will allow for subgroup analyses (e.g. comorbid disorders), for the iden- tification of responders and nonresponders of each treat- Assessments are carried out at baseline, and in weeks 8, 15 and ment approach, for a sufficient power to detect differenc- 25 (after treatment). This procedure is analogous to Davidson et es between treatments and for generalization of results. al.  . The primary endpoints are in week 25 (after treatment) and 6 and 12 months after the end of treatment. Assessments in Psychological, genetic, neural and health economic pa- weeks 8 and 15 ensure intent-to-treat analyses. As studies of long- rameters will be related to treatment outcome, and vari- term effects in SP are scant  , follow-up studies will be carried ables for differential treatment indication will be gained. out not only 6 months but also 12 months after termination of treatment (consistent with EMEA guidelines 6 ). The assessment instruments and their purposes are described in table 1 . For qual-ity assurance, all diagnostic sessions will be videotaped. The in- terrater reliability for all observer-rated instruments will be care- fully controlled. For the self-report instruments used in the study, sufficient psychometric properties have been demonstrated (see The SOPHO-NET is supported by the following international experts: Dr. Barber and Dr. Crits-Christoph (University of Pennsylvania), Dr. Bö-gels and Dr. Wijts (University of Maastricht), Dr. Clark (King’s College London), Dr. Gabbard (Baylor College of Medicine Houston), Dr. Kendall (University of Philadelphia), Dr. Pilkonis (University of Pittsburgh, Penn- www.controlled-trials.com/ISRCTN53517394. www.emea.eu.int/pdfs/human /ewp/363503en.pdf. Fig. 1. Consort flowchart of the SOPHO-
NET treatment study A.
Sample Sizes and Power Calculations for Study A Clark’s Cognitive Therapy  , which was shown to be effica- In order to detect even a small difference between CBT and cious in several trials [8, 10, 25] . This approach differs in some STPP, which corresponds to a difference in response rates of 15% essential components from the program designed by Heimberg et (h = 0.30)  , 217 patients are required in each treatment group al.  , which is currently one of the best supported psychothera- to achieve a statistical power of 0.90 at ␣ = 0.05 using a 2-tailed peutic treatments for SP. Clark and Wells’  approach has a test. The dropout rates of psychotherapy studies of SP range from wider range of therapeutic procedures, all of which explicitly fo- 9.2%  to 28%  , with a mean dropout rate of 15%. At a drop- cus on reversing the maintaining processes specified in their out rate of 15%, a total sample of 512 patients is required to ensure model  . This approach includes the following steps: (1) an in- dividual version of the Clark and Wells model is derived along with the patient. It serves as a point of reference during the treat- ment; (2) key safety behaviors are identified and their dysfunc- All of the participating centers run well-established outpatient tional effects are demonstrated with an experiential exercise in clinics. Patients will be recruited by these institutions. Informa- which patients role-play difficult social situations while focusing tion about SP and the SOPHO-NET research projects will be pub- attention on themselves and using their safety behaviors and then lished by the mass media in order to recruit a sufficient number focusing attention externally and attempt to drop their safety be- haviors; (3) patients are trained to focus their attention externally, to reduce their dysfunctional self-monitoring and to obtain more accurate information on how they are responded to by others; (4) CBT and STPP are the methods most frequently applied in videofeedback is applied to demonstrate the discrepancy between clinical practice to treat anxiety disorders  . As the response their distorted self-images and their actual social performance; rates of the available treatments are not yet sufficient, further re- (5) extensive use of behavioral experiments is made in which pa- search is required. Experts in the field suggest that the response tients specify their feared outcomes for various social situations rates may be improved by longer and more intensive treatment  . and then test out whether they occurred during planned expo- Thus, in the present study up to 30 sessions of CBT or STPP are sure, and (6) problematic anticipatory or postevent processing is carried out. The CBT applied in the present study is based on identified and modified, and dysfunctional assumptions are Table 1. Assessment instruments and time of assessment of study A and study B2
ADIS-IV = Anxiety Disorders Interview Schedule Adult Version (rating scale for severity of symptoms) [18, 19]; BDI = Beck Depression Inventory ; CCRT = Core Conflictual Relationship Theme Method [28, 30]; CSSRI = Client Sociodemographic and Service Receipt Inventory [42, 43]; CTACS = Cognitive Therapy Adherence and Competence Scale ; EQ-5D = EuroQol Question-naire [44–46]; FSKN = Frankfurter Selbstkonzept-Skalen (Frankfurt Self-Concept Scales) ; HAQ = Helping Alliance Question-naire ; IIP = Inventory of Interpersonal Problems ; LSAS = Liebowitz Social Anxiety Scale ; PACS-SE = Penn Adherence and Competence Scale for SET [28, 36]; SCID I = Structured Clinical Interview for DSM-IV Axis I Disorders ; SCID II = Structured Clinical Interview for DSM-IV Axis II Disorders ; SF-12/SF-6 D = Fragebogen zum Gesundheitszustand (Quality of Life Question-naire) [52, 53]; SPAI = Social Phobia and Anxiety Inventory [54, 55]; TOSCA = Test of Self-Conscious Affects [56, 57].
modified by behavioral experiments and cognitive restructuring. symptoms and of the underlying CCRT  . In order to tailor SET With regard to psychodynamic therapy, 2 studies demonstrated specifically to the treatment of SP, the psychodynamic research the efficacy of STPP in the treatment of SP [6, 9] . However, in group of the SOPHO-NET integrated specific principles for inter- these studies the sample size was small or no treatment manual ventions derived from the psychodynamic models of SP [31, 32] was used for STPP. In the present study, a treatment manual for into SET  . This SP-specific manual will be used in the present STPP that is based on Luborsky’s Supportive-Expressive Therapy study. The SP-specific intervention principles include the follow- (SET)  will be used. SET is among the empirically best sup- ing: (a) informing the patient about the disorder at the beginning ported manualized models of STPP  . SET focuses on the ‘Core of treatment; (b) establishing a secure positive therapeutic alli- Conflictual Relationship Theme’ (CCRT) [28, 30] . A CCRT con- ance to modify insecure attachments; (c) focusing on the affect of sists of 3 components: a wish (W), a response from the others (RO) shame and point out its central role in SP; (d) encouraging the and a response from the self (RS). In this scheme, RS represents patient to actively confront rather than avoid the anxiety-produc- the patient’s symptoms, e.g. SP. For a patient with SP, the CCRT ing situation; (e) supporting the patient in establishing a self-af- could be, for example: ‘I wish to be approved of by others (W). firming inner dialogue; (f) exploring and discussing the use of However, the others will humiliate me (RO). I feel ashamed and psychotropic substances and medication used by many patients get afraid of meeting other people, so I have decided to avoid ex- with SP to reduce anxiety, and (g) helping the patient improve posing myself ’ (RS, symptoms of SP). SET uses both supportive social skills. Further interventions specific to the treatment of SP and expressive interventions. In SET the establishment of a help- including, for example, the handling of counter-transference ing alliance is a central aspect of supportive interventions  . problems are described in the treatment manual  . Whereas the Expressive (i.e. interpretive) interventions enhance the patient’s Clark and Wells approach has already been used in controlled cognitive and emotional understanding of his or her present studies and the CBT therapists of our study are already familiar with it, the STPP approach is based on a new manual. Thus, CBT than patients with insecure features and/or disorganized states of is expected to be superior in the first 50% of the treated patients. mind. Furthermore, self-reported attachment is likely to change In the second half of the treated patients, these differences are after successful therapy, indicating increased security. In project B2, an economic evaluation of STPP and CBT will be conducted alongside the multicenter treatment study A. The direct and in- Treatment Implementation and Treatment Integrity (Q) direct costs, utilities, quality-adjusted life years and incremental As mentioned above, a specific unit (Q) for project manage- cost-effectiveness ratios of the treatment strategies (STPP, CBT, ment and quality assurance has been developed. Within Q, a spe- waiting list) will be measured and compared (principal investiga- cial subunit has been established to ensure adequate and compa- tor: Dr. König, Leipzig). Project C1 explores the impact of genetic rable treatment implementation in all trial sites as well as reliabil- variation in the serotonin transporter gene on the severity of SP ity of diagnostic assessments. Representatives of both CBT (Dr. and on the outcome of psychotherapy (principal investigator: Dr. Stangier) and STPP (Dr. Beutel) are responsible for adequate im- Vormfelde, Göttingen). The short allele and the S 10 allele are ex- plementation of each approach. By this procedure, investigator pected to predispose to severer symptoms of SP. The long allele allegiance effects are balanced between the 2 rival approaches and and specifically the L 12 haplotype are predicted to be associated controlled for. A total of at least 20 therapists per treatment con- with a more favorable treatment outcome. In project C2, struc- dition are included. In order to be accepted into the trial, thera- tural and functional abnormalities of amygdala and hippocam- pists must have an advanced or completed clinical training of pus in patients with SP are examined by neuroimaging including CBT or STPP, respectively. In both treatment conditions thera- their possible therapy-induced changes after CBT or STPP, re- pists receive equivalent manualized training and supervision spectively (principal investigator: Dr. Irle, Göttingen). In study  . Before treating study patients, therapist’s competence is en- C2, both healthy control subjects and panic disorder patients hanced in a 20-hour training program. During the trial, thera- pists receive group supervision by highly experienced and spe-cifically trained local supervisors. Supervision is carried out ev-ery 2 weeks during the first 6 months of the treatment phase and monthly during the remaining 12 months. Adherence and com- Discussion
petence for CBT is assessed by use of the Cognitive Therapy Ad-herence and Competence Scale (CTACS)  , for STPP by use of The SOPHO-NET research plan presented here imple- the Penn Adherence and Competence Scale for Supportive-Ex-pressive Therapy (PACS-SE) [28, 36] . CTACS and PACS-SE are ments a number of methodological refinements that have applied to videotaped therapy sessions. For that purpose, inde- previously been suggested. Among these methodological pendent raters receive 60 h of training  following the training and substantial perspectives are the following: (a) estab- procedures by Barber and Crits-Christoph  for STPP and by lishing a specific unit for quality assurance, and for pro- Hill et al.  for CBT. Randomly selected videotapes will be used for interrater reliability assessment. To be included in the study, gram and data management; (b) comparison of the psy- therapists have to demonstrate a sufficient level of competence in chotherapeutic treatments that are most common and the treatment of at least 2 pilot cases before conducting actual relevant for clinical practice; (c) use of refined treatment trial therapies. Recommended by Dr. Barber, this therapist pre- models to improve responder rates; (d) highly elaborated requisite relies on a cutoff value of 6 4 in CTACS and PACS-SE, measures to ensure treatment integrity; (e) methods respectively, as a criterion for acceptable competence. During the trial, therapists are supported by continuous feedback given by against bias, in particular control for investigator alle- the local trial site supervisors to prevent ‘drifting’. Additionally, giance effects (e.g. by co-investigatorship of experts in as a backup, the subunit responsible for treatment implementa- CBT and STPP, assurance of adherence and competence); tion will evaluate randomly selected videotapes of therapy ses- (f) multicenter approach allowing for tests of generaliz- sions. Should the therapeutical quality fall below the ‘red line’, ability and subgroup analyses (e.g. patients benefiting therapists will be given feedback. Those who fail to meet manual-ized standards will receive additional supervision. Should the most and least from STPP or CBT; study of nonre-therapists continue to provide less than adequate therapeutical sponders); (g) inclusion of comorbid disorders to ensure performance, they will be withdrawn from the study. For the sta- clinically representative samples and to study the impact tistical evaluation of treatment integrity, PACS-SE and CTACS of comorbid disorders on outcome; (h) study of gender will be applied by blind raters to randomly drawn videotaped ses- and developmental aspects (focus on women and elderly); sions. The 2 treatments are expected to differ significantly with regard to manualized treatment-specific interventions  .
(i) study of attachment styles as predictors of outcome; (j) inclusion of neurobiological research, and (k) inclusion of cost-effectiveness analysis. In detail, the following hy- Study A is complemented by 4 add-on projects highly relevant potheses will be tested in the SOPHO-NET projects: with to SP. For reasons of space limitations, the add-on projects will be regard to the treatment study A, the insufficient response described in more detail elsewhere. Project B1 examines the as-sociation between attachment style and treatment outcome (prin- rates reported in the presently available studies of SP are cipal investigator: Dr. Strauss, Jena). Patients revealing a secure expected to be improved by a longer and more intensive organized attachment are expected to achieve a better outcome treatment of up to 30 sessions. Differential effects are hy- pothesized: CBT is anticipated to be superior to STPP (study C2). Furthermore, specific genetic polymorphisms with regard to symptoms of SP, whereas STPP is expected are expected to be associated with symptoms of SP (study to be superior with regard to improvements in self-image C1). With regard to cost-effectiveness, the treatments are and interpersonal relationships. With regard to patient anticipated to pay off (B2). Thus, the SOPHO-NET re-characteristics, subjects with secure attachment are like- search program can be expected to avoid shortcomings ly to yield a better outcome than those insecurely attached that contribute to the crisis of psychiatric research  . (study B1). Functional and structural neural abnormali- This research program is likely to yield important infor- ties found in patients with SP are hypothesized to nor- mation for both the understanding and treatment of SP malize after treatment with CBT or STPP, respectively and for psychotherapy research in general. References
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