Transfer of manualized CBT for social phobia into clinical practice (SOPHO-PRAX) : a study protocol for a cluster-randomized controlled trial

Background: Cognitive-behavioral therapy (CBT) is generally known to be efficacious in the treatment of social phobia when applied in RCT's, namely when the treatment manual is based on the Clark-Wells approach. However, little is known about the efficacy of manualized treatments in routine clinical practice (Phase IV of psychotherapy research). The present study (SOPHO-PRAX) is a continuation of a large multi-centre randomized clinical trial (SOPHO-NET) and analyses the extent to which additional training practitioners in manualized procedures enhances treatment effect. Methods: N = 36 private practitioners will be included in three treatment centres and randomly designated to either training in manualized CBT or no specific training. The treatment effects of the therapies conducted by both groups of therapists will be compared. A total of 162 patients (N = 116 completers; N = 58 per condition) will be enrolled. Liebowitz Social Anxiety Scale (LSAS) will serve as primary outcome measure. Remission from social phobia is defined as LSAS total [less than or equal to] 30 points. Data will be collected at treatment begin, after 8, 15, and 25 sessions (50 mins. each), at treatment completion, as well at 6 and 12 months post-treatment. Discussion: The present CBT trial combines elements of randomized-controlled trials and naturalistic studies in an innovative way. It will directly inform about the incremental effects of procedures established in a controlled trial into clinical practice. Study results are relevant to health care decisions and policy. They may serve to improve quality of treatment, and shorten the timeframe between the development and widespread dissemination of effective methods, thereby reducing health cost expenditures. The results of this study will not only inform about the degree to which the new methods lead to an improvement of treatment course and outcome, but also about whether the effects of routine psychotherapeutic treatment are comparable to those of the controlled, strictly manualized treatments of the SOPHO-NET study. Trial Registration: ClinicalTrials.gov identifier: NCT01388231. This study was funded by the German Federal Ministry of Education and Research (SOPHO-NET: BMBF 01GV0607; SOPHO-PRAX: BMBF 01GV1001)

Ungenauigkeit der Interozeption und Abwendung der Aufmerksamkeit bei Atemwegserkrankungen: Asthma bronchiale versus chronisch obstruktive Bronchitis

In der vorliegenden Studie wurde die Hypothese geprüft, daß Asthmatiker die Aufmerksamkeit von eigenen Körperprozessen ablenken und eine Ungenauigkeit bei der Interozeption relevanter Atemwegsobstruktionen aufweisen. Weiterhin prüften wir die Frage, inwieweit die postulierte Aufmerksamkeitsabwendung generalisiert ist und sich auch auf die nicht atemwegsbezogene Symptomwahrnehmung und die private Selbstaufmerksamkeit bezieht. Die Interozeptionsgenauigkeit wurde als Diskrepanz zwischen subjektivem Urteil und objektiver Atemfunktion bei spirometrischen Messungen berechnet, die anderen Variablen mittels Fragebögen operationalisiert. Es wurden insgesamt 91 Patienten einer Rehabilitationseinrichtung untersucht: 30 Asthmatiker, 30 Patienten mit chronisch obstruktiver Bronchitis (COB) und 31 Kontrollpatienten ohne Atemwegserkrankung. Die Ergebnisse deuten auf eine spezifisch atemwegsbezogene Aufmerksamkeitsablenkung sowie eine Überschätzung von Obstruktionen bei Asthmatikern hin. Überraschend zeigen auch die COB-Patienten auffällige Ergebnismuster in Richtung einer Unterschätzung von Obstruktionen sowie verminderter Selbstaufmerksamkeit. Die Ergebnisse lassen sich im Rahmen verhaltensmedizinischer Überlegungen interpretieren.The hypothesis that asthmatic patients draw their attention away from bodily processes and show inaccurate interoception with regard to relevant airway obstructions was tested in this study. Additionally, we examined whether this postulated withdrawal of attention can also be generalized for the perception of non-airway related symptoms as well as for private self-consciousness. Accuracy of interoception was measured as the discrepancy between subjective judgement of obstruction and objective obstruction as shown in spirometric tests. Other variables were operationalized by self-reports. Ninetyone patients in a rehabilitation hospital were tested: 30 asthmatic patients, 30 patients with chronic obstructive bronchitis (COB), and 31 control subjects without any airway disease. Asthmatic patients showed attention withdrawal only with regard to bronchial airways. However, they also indicated an overestimation of airway obstruction. Surprisingly, deviant results were also found for the COB patients including underestimation of obstructions and lower self awareness. All results were interpreted from the perspective of behavioral medicine.Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich

Screening for Generalized Anxiety Disorder in inpatient psychosomatic rehabilitation: pathological worry and the impact of depressive symptoms

Objective: Pathological worry is considered to be a defining feature for Generalized Anxiety Disorder (GAD). The Penn State Worry Questionnaire (PSWQ) is an instrument for assessing pathological worry. Two earlier studies demonstrated the suitability of the PSWQ as screening instrument for GAD in outpatient and non-clinical samples. This study examined the suitability of the PSWQ as a screening instrument for GAD in a German inpatient sample (N=237). Furthermore, a comparison of patients with GAD and patients with depression and other anxiety disorders regarding pathological worry and depression was carried out in a sub-sample of N=118 patients

How Well Do Randomized Trials Inform Decision Making: Systematic Review Using Comparative Effectiveness Research Measures on Acupuncture for Back Pain

Background: For Comparative Effectiveness Research (CER) there is a need to develop scales for appraisal of available clinical research. Aims were to 1) test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2) evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making. Methods: We searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ≥30 patients in the acupuncture group. Papers were evaluated by 5 raters. Principal Findings: From 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients) were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02-0.60), which improved after consensus discussions to 0.20-1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness. Conclusion: Both instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments. © 2012 Witt et al.published_or_final_versio

Transfer of manualized CBT for social phobia into clinical practice (SOPHO-PRAX): a study protocol for a cluster-randomized controlled trial

Abstract Background Cognitive-behavioral therapy (CBT) is generally known to be efficacious in the treatment of social phobia when applied in RCTs, namely when the treatment manual is based on the Clark-Wells approach. However, little is known about the efficacy of manualized treatments in routine clinical practice (Phase IV of psychotherapy research). The present study (SOPHO-PRAX) is a continuation of a large multicenter randomized clinical trial (SOPHO-NET) and analyzes the extent to which additional training practitioners in manualized procedures enhances treatment effect. Methods/design Thirty-six private practitioners will be included in three treatment centers and randomly designated to either training in manualized CBT or no specific training. The treatment effects of the therapies conducted by both groups of therapists will be compared. A total of 162 patients (n = 116 completers; n = 58 per condition) will be enrolled. Liebowitz Social Anxiety Scale (LSAS) will serve as primary outcome measure. Remission from social phobia is defined as LSAS total ≤30 points. Data will be collected at treatment begin, after 8, 15, and 25 sessions (50 min each), at treatment completion, as well at 6 and 12 months post-treatment. Discussion The present CBT trial combines elements of randomized controlled trials and naturalistic studies in an innovative way. It will directly inform about the incremental effects of procedures established in a controlled trial into clinical practice. Study results are relevant to healthcare decisions and policy. They may serve to improve quality of treatment, and shorten the time frame between the development and widespread dissemination of effective methods, thereby reducing health cost expenditure. The results of this study will not only inform about the degree to which the new methods lead to an improvement of treatment course and outcome, but also about whether the effects of routine psychotherapeutic treatment are comparable to those of the controlled, strictly manualized treatments of the SOPHO-NET study. Trial registration ClinicalTrials.gov identifier: NCT01388231. This study was funded by the German Federal Ministry of Education and Research (SOPHO-NET: BMBF 01GV0607; SOPHO-PRAX: BMBF 01GV1001).</p

Interindividual Differences in Treatment Effects Based on Structural Equation Models with Latent Variables: An EffectLiteR Tutorial

Mayer A, Zimmermann J, Hoyer J, et al. Interindividual Differences in Treatment Effects Based on Structural Equation Models with Latent Variables: An EffectLiteR Tutorial. Structural Equation Modeling: A Multidisciplinary Journal. 2020;27(5):798-816.The investigation of interindividual differences in the effects of a treatment is challenging, because many constructs-of-interest in psychological research such as depression or anxiety are latent variables and modeling heterogeneity in treatment effects requires interactions and potentially non-linear relationships. In this paper, we present a tutorial of the EffectLiteR approach that allows for estimating individual treatment effects based on latent variable models. We describe step by step how to apply the approach using the EffectLiteR software package with data from the multicenter randomized controlled trial of the Social Phobia Psychotherapy Network (SOPHO-NET) and provide guidelines and recommendations for researchers. The focus of the paper is on explaining the results of a comprehensive effect analysis in an accessible language and on highlighting the opportunities the EffectLiteR approach offers for analyzing interindividual differences in treatment effects

Liebowitz Social Anxiety Scale (LSAS) : Optimal cut points for remission and response in a German sample

The Liebowitz Social Anxiety Scale (LSAS) is the most frequently used instrument to assess social anxiety disorder (SAD) in clinical research and practice. Both a self‐reported (LSAS‐SR) and a clinician‐administered (LSAS‐CA) version are available. The aim of the present study was to define optimal cut‐off (OC) scores for remission and response to treatment for the LSAS in a German sample. Data of N = 311 patients with SAD were used who had completed psychotherapeutic treatment within a multicentre randomized controlled trial. Diagnosis of SAD and reduction in symptom severity according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th edition, served as gold standard. OCs yielding the best balance between sensitivity and specificity were determined using receiver operating characteristics. The variability of the resulting OCs was estimated by nonparametric bootstrapping. Using diagnosis of SAD (present vs. absent) as a criterion, results for remission indicated cut‐off values of 35 for the LSAS‐SR and 30 for the LSAS‐CA, with acceptable sensitivity (LSAS‐SR: .83, LSAS‐CA: .88) and specificity (LSAS‐SR: .82, LSAS‐CA: .87). For detection of response to treatment, assessed by a 1‐point reduction in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th edition, rating, a reduction of 28% for the LSAS‐SR and 29% for the LSAS‐CA yielded the best balance between sensitivity (LSAS‐SR: .75, LSAS‐CA: .83) and specificity (LSAS‐SR: .76, LSAS‐CA: .80). To our knowledge, we are the first to define cut points for the LSAS in a German sample. Overall, the cut points for remission and response corroborate previously reported cut points, now building on a broader data basis

Optimal Cut Points for Remission and Response for the German Version of the Social Phobia Anxiety Inventory (SPAI)

Objective: The German version of the Social Phobia and Anxiety Inventory (SPAI-G) is avalidated measure for the detection of social anxiety disorder (SAD). The aim of the presentstudy was to develop optimal cut points (OC) for remission and response to treatment for theSPAI-G. Methods: We used Receiver Operating Characteristic methods and bootstrapping to analysethe data of 359 patients after psychotherapeutic treatment. OCs where defined as the cut pointswith the highest sensitivity and specificity after bootstrapping. Results: For remission, an OC of 2.79 was found, and for response, a change in score frompre- to posttreatment by 11% yielded best results. Conclusions: The OC we identified for remission may be used to improve the diagnostic utilityof the SPAI-G. However, the cut point for response achieved only borderline-acceptable levelsof sensitivity and specificity, calling into doubt their utility in clinical and research setting.Fragestellung: Die deutsche Version des Social Phobia and Anxiety Inventory (SPAI-G) ist einvalidiertes Maß bei der Erkennung von Sozialer Phobie. Das Ziel der vorliegenden Studie wardie Entwicklung optimaler Cut-Points (OC) für Remission und Response to treatment für dasSPAI-G. Methode: Wir verwendeten Receiver Operating Characterstic Methoden und Bootstrapping,um die Daten von 359 Patienten nach Beendigung einer psychotherapeutischen Behandlungzu untersuchen. Ergebnisse: Als optimaler Cut-Point wurde der Cut-Point mit der höchsten Sensitivität undSpezifität definiert. Für Remission erreichte ein optimaler Cut-Point von 2.79 und für Re-sponse eine Prä-Post-Veränderung von 11 % die besten Ergebnisse. Diskussion: Der von uns identifizierte optimale Cut-Point für Remission kann zur Verbesse-rung des diagnostischen Nutzens der SPAI-G genutzt werden. Der Cut-Point für Responseerreichte allerdings nur grenzwertige Sensitivität und Spezifität, weshalb sein Nutzen für kli-nische und wissenschaftliche Zwecke zweifelhaft ist