Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice
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ClinicalTrials.gov Identifier: NCT01388231 |
Recruitment Status
: Unknown
Verified July 2011 by Technische Universität Dresden.
Recruitment status was: Recruiting
First Posted
: July 6, 2011
Last Update Posted
: July 8, 2011
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Condition or disease | Intervention/treatment | Phase |
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Social Phobia | Behavioral: CBT-Manualized Intervention Behavioral: CBT-Treatment as Usual | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 116 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice (SophoPrax) |
Study Start Date : | September 2010 |
Estimated Primary Completion Date : | June 2013 |
Estimated Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Manualized CBT Group
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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Behavioral: CBT-Manualized Intervention
Cognitive-behavioral therapy (CBT) for social phobia following the Clark and Wells (1995) model of social phobia.
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Active Comparator: CBT Group -Treatment as Usual
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.
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Behavioral: CBT-Treatment as Usual
Cognitive-behavioral therapy for social phobia following no specific model.
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- Severity of Social Phobia Symptoms [ Time Frame: 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. ]Symptom severity will be assessed via the Liebowitz Social Anxiety Scale (LSAS).
- Diagnostic Status of Social Phobia [ Time Frame: 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. ]Diagnostic status will be assessed via SCID-I.
- Assessment of Symptoms of Social Anxiety (Performance Anxiety) [ Time Frame: 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. ]To further assess symptoms of social anxiety, the Social Phobia Anxiety Inventory (SPAI) will be used.
- Assessment of Symptoms of Social Anxiety (Social Phobic Cognitions) [ Time Frame: 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. ]To further assess cognitive symptoms of social anxiety, the Social Phobic Cognitions Questionnaire will be used.
- Assessment of a Change in Safety Behaviors in Social Anxiety [ Time Frame: 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. ]To further assess safety behaviors in social anxiety the Safety Behaviors Questionnaire will be used.
- Assessment of Other Social Anxiety Symptoms [ Time Frame: 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. ]To further assess symptoms of social anxiety, the Brief Social Phobia Scale(BSPS) will be used.
- Assessment of Symptoms of Depression [ Time Frame: 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. ]To further assess symptoms of depression, the Beck Depression Inventory (BDI), will be employed.
- Assessment of Emotion Regulation [ Time Frame: 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. ]To assess the level of emotion regulation, the Affective Style Questionnaire (ASQ) will be employed.
- Assessment of the Quality of Life [ Time Frame: 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. ]To assess the quality of life in patients, the Quality of Life (QoL) questionnaire will be used.
- Assessment of the Times Missing from Work [ Time Frame: 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. ]The times missing from work will be assessed via a separate questionnaire.
- Assessment of the General Level of Severity of Social Anxiety Symptoms [ Time Frame: 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. ]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.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- primary diagnosis of Social Phobia (SCID-I)
- Liebowitz Social Anxiety Inventory Scale (LSAS) equal to or greater than 30
- age between 18 and 70 years
Exclusion Criteria:
- psychotic disorder, risk of self-harm, acute substance related disorders, personality disorders except for Cluster C (SCID-II)
- organic mental disorder
- severe medical conditions
- ongoing psychotherapy or initiation
- psychopharmacological treatment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388231
Contact: Juergen Hoyer, Prof. Dr. | 35146336986 ext +49 | hoyer@psychologie.tu-dresden.de | |
Contact: Stephen C Crawcour, Dr. | 35146336964 ext +49 | crawcour@psychologie.tu-dresden.de |
Germany | |
Outpatient clinical services and day clinic center Technical University Dresden (IAP-TUD) | Recruiting |
Dresden, Saxony, Germany, 01187 | |
Contact: Juergen Hoyer, Prof. Dr. 35146336986 ext +49 hoyer@psychologie.tu-dresden.de | |
Contact: Stephen C Crawcour, Dr. 35146336964 ext +49 crawcour@psychologie.tu-dresden.de | |
Principal Investigator: Juergen Hoyer, Prof. Dr. |
Principal Investigator: | Juergen Hoyer, Prof. Dr. | Technische Universität Dresden |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Prof. Dr. Juergen Hoyer, Dresden University of Technology |
ClinicalTrials.gov Identifier: | NCT01388231 History of Changes |
Other Study ID Numbers: |
01GV1001 |
First Posted: | July 6, 2011 Key Record Dates |
Last Update Posted: | July 8, 2011 |
Last Verified: | July 2011 |
Keywords provided by Technische Universität Dresden:
social phobia, cognitive-behavioral therapy, treatment |
Additional relevant MeSH terms:
Phobic Disorders Phobia, Social Anxiety Disorders Mental Disorders |