Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2011 by Technische Universität Dresden.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01388231

First Posted: July 6, 2011

Last Update Posted: July 8, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Goethe University

University of Göttingen

Information provided by:

Technische Universität Dresden

Purpose

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?

Condition	Intervention	Phase
Social Phobia	Behavioral: CBT-Manualized Intervention Behavioral: CBT-Treatment as Usual	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	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)

Resource links provided by NLM:

MedlinePlus related topics: Phobias

U.S. FDA Resources

Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:

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).

Secondary Outcome Measures:

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.


Estimated Enrollment:	116
Study Start Date:	September 2010
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Behavioral: CBT-Manualized Intervention Cognitive-behavioral therapy (CBT) for social phobia following the Clark and Wells (1995) model of social phobia.
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.	Behavioral: CBT-Treatment as Usual Cognitive-behavioral therapy for social phobia following no specific model.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Contacts


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

Locations


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.

Sponsors and Collaborators

Technische Universität Dresden

Goethe University

University of Göttingen

Investigators


Principal Investigator:	Juergen Hoyer, Prof. Dr.	Technische Universität Dresden

More Information

Publications:

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. Erratum in: Psychother Psychosom. 2009;78(1):41.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Prof. Dr. Juergen Hoyer, Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT01388231 History of Changes
Other Study ID Numbers:	01GV1001
First Submitted:	June 8, 2011
First Posted:	July 6, 2011
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 Anxiety Disorders Mental Disorders

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