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

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

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?

Study Overview

• Status: Unknown
• Conditions: Social Phobia
• Intervention / Treatment: Behavioral: CBT-Manualized Intervention; Behavioral: CBT-Treatment as Usual

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Juergen Hoyer, Prof. Dr.; Phone Number: +49 35146336986; Email: hoyer@psychologie.tu-dresden.de
• Study Contact Backup: Name: Stephen C Crawcour, Dr.; Phone Number: +49 35146336964; Email: crawcour@psychologie.tu-dresden.de

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01187
      • Recruiting
      • Outpatient clinical services and day clinic center Technical University Dresden (IAP-TUD)
      • Contact: Juergen Hoyer, Prof. Dr.; Phone Number: +49 35146336986; Email: hoyer@psychologie.tu-dresden.de
      • Contact: Stephen C Crawcour, Dr.; Phone Number: +49 35146336964; Email: crawcour@psychologie.tu-dresden.de
      • Principal Investigator: Juergen Hoyer, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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)	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.

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: Goethe University; University of Göttingen
• Investigators: Principal Investigator: Juergen Hoyer, Prof. Dr., Technische Universitat Dresden

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: July 4, 2011
• First Posted (Estimate): July 6, 2011

Study Record Updates

• Last Update Posted (Estimate): July 8, 2011
• Last Update Submitted That Met QC Criteria: July 7, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: social phobia, cognitive-behavioral therapy, treatment
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobia, Social; Phobic Disorders
• Other Study ID Numbers: 01GV1001