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

Social Phobia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01388231
• Other study ID #: 01GV1001
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 8, 2011
• Last updated: July 7, 2011
• Start date: September 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2011
• Source: Technische Universität Dresden
• Contact: Juergen Hoyer, Prof. Dr.
• Phone: 35146336986
• Email: hoyer[@]psychologie.tu-dresden.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobic Disorders
• Social Phobia

Intervention

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

Locations

Country	Name	City	State
Germany	Outpatient clinical services and day clinic center Technical University Dresden (IAP-TUD)	Dresden	Saxony

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität Dresden	Goethe University, University of Göttingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	Assessment of Symptoms of Social Anxiety (Performance Anxiety)	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No