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| Name | Class |
|---|---|
| Goethe University | OTHER |
| University of Göttingen | OTHER |
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The study aims at examining the effects of additional training in manualized cognitive-behavioral therapy (CBT) on outcome in routine psychotherapy for social phobia. The investigators will investigate how CBT, specifically the treatment procedures and manuals proposed by Clark and Wells (1995), can be transferred from controlled trials into the less structured setting of routine clinical care, and whether the health care system benefits from such developments. Private practitioners (N=36) will be randomized to one of two treatment conditions (i.e., training in manualized CBT vs. treatment as usual without specific training). The investigators plan to enroll 160 patients (80 per condition) to be able to detect differences of d=.50 between conditions at 1-beta=.80, given the drop-out rate of 25% (N=116 completers; N=58 per condition). The study is genuinely designed to promote faster and more widespread dissemination of effective interventions. The following research questions can be examined: (1) Can manualized CBT be successfully implemented into routine outpatient care? (2) Will the new methods lead to an improvement of treatment courses aned outcomes? (3) Will treatment effects in routine psychotherapeutic treatments be comparable to those of the controlled, strictly manualized treatment of the main study?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manualized CBT Group | Active Comparator | The present group is comprised of clinical practitioners performing cognitive-behavioral therapy (CBT) on social phobic patients after receiving structured clinical training on the treatment of social phobia based on the Clark and Wells (1995) model. |
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| CBT Group -Treatment as Usual | Active Comparator | The present group is comprised of clinical practitioners performing cognitive-behavioral therapy (CBT) on social phobic patients, while receiving no structured training in the treatment of social phobia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-Manualized Intervention | Behavioral | Cognitive-behavioral therapy (CBT) for social phobia following the Clark and Wells (1995) model of social phobia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Social Phobia Symptoms | Symptom severity will be assessed via the Liebowitz Social Anxiety Scale (LSAS). | Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Status of Social Phobia | Diagnostic status will be assessed via SCID-I. | Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment. |
| Assessment of Symptoms of Social Anxiety (Performance Anxiety) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juergen Hoyer, Prof. Dr. | Contact | 35146336986 | +49 | hoyer@psychologie.tu-dresden.de |
| Stephen C Crawcour, Dr. | Contact | 35146336964 | +49 | crawcour@psychologie.tu-dresden.de |
| Name | Affiliation | Role |
|---|---|---|
| Juergen Hoyer, Prof. Dr. | Technische Universität Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient clinical services and day clinic center Technical University Dresden (IAP-TUD) | Recruiting | Dresden | Saxony | 01187 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18852500 | Background | Leichsenring F, Hoyer J, Beutel M, Herpertz S, Hiller W, Irle E, Joraschky P, Konig HH, de Liz TM, Nolting B, Pohlmann K, Salzer S, Schauenburg H, Stangier U, Strauss B, Subic-Wrana C, Vormfelde S, Weniger G, Willutzki U, Wiltink J, Leibing E. The social phobia psychotherapy research network. The first multicenter randomized controlled trial of psychotherapy for social phobia: rationale, methods and patient characteristics. Psychother Psychosom. 2009;78(1):35-41. doi: 10.1159/000162299. Epub 2008 Oct 14. | |
| 22647314 |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| CBT-Treatment as Usual | Behavioral | Cognitive-behavioral therapy for social phobia following no specific model. |
|
To further assess symptoms of social anxiety, the Social Phobia Anxiety Inventory (SPAI) will be used. |
| Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment. |
| Assessment of Symptoms of Social Anxiety (Social Phobic Cognitions) | To further assess cognitive symptoms of social anxiety, the Social Phobic Cognitions Questionnaire will be used. | Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment. |
| Assessment of a Change in Safety Behaviors in Social Anxiety | To further assess safety behaviors in social anxiety the Safety Behaviors Questionnaire will be used. | Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment. |
| Assessment of Other Social Anxiety Symptoms | To further assess symptoms of social anxiety, the Brief Social Phobia Scale(BSPS) will be used. | Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment. |
| Assessment of Symptoms of Depression | To further assess symptoms of depression, the Beck Depression Inventory (BDI), will be employed. | Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment. |
| Assessment of Emotion Regulation | To assess the level of emotion regulation, the Affective Style Questionnaire (ASQ) will be employed. | Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment. |
| Assessment of the Quality of Life | To assess the quality of life in patients, the Quality of Life (QoL) questionnaire will be used. | Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment. |
| Assessment of the Times Missing from Work | The times missing from work will be assessed via a separate questionnaire. | Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment. |
| Assessment of the General Level of Severity of Social Anxiety Symptoms | To get a global impression from the diagnosticitian on the general level of severity of social anxiety symptoms, the Clinical Global Impression scale (CGI) will be used. | Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment. |
| Derived |
| Crawcour S, Leibing E, Ginzburg D, Stangier U, Wiltink J, Hoyer J. Transfer of manualized CBT for social phobia into clinical practice (SOPHO-PRAX): a study protocol for a cluster-randomized controlled trial. Trials. 2012 May 30;13:70. doi: 10.1186/1745-6215-13-70. |