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

Primary Purpose

Social Phobia

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
CBT-Manualized Intervention
CBT-Treatment as Usual
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Phobia focused on measuring social phobia, cognitive-behavioral therapy, treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Outpatient clinical services and day clinic center Technical University Dresden (IAP-TUD)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Manualized CBT Group

CBT Group -Treatment as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Severity of Social Phobia Symptoms
Symptom severity will be assessed via the Liebowitz Social Anxiety Scale (LSAS).

Secondary Outcome Measures

Diagnostic Status of Social Phobia
Diagnostic status will be assessed via SCID-I.
Assessment of Symptoms of Social Anxiety (Performance Anxiety)
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)
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
To further assess safety behaviors in social anxiety the Safety Behaviors Questionnaire will be used.
Assessment of Other Social Anxiety Symptoms
To further assess symptoms of social anxiety, the Brief Social Phobia Scale(BSPS) will be used.
Assessment of Symptoms of Depression
To further assess symptoms of depression, the Beck Depression Inventory (BDI), will be employed.
Assessment of Emotion Regulation
To assess the level of emotion regulation, the Affective Style Questionnaire (ASQ) will be employed.
Assessment of the Quality of Life
To assess the quality of life in patients, the Quality of Life (QoL) questionnaire will be used.
Assessment of the Times Missing from Work
The times missing from work will be assessed via a separate questionnaire.
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.

Full Information

First Posted
June 8, 2011
Last Updated
July 7, 2011
Sponsor
Technische Universität Dresden
Collaborators
Goethe University, University of Göttingen
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1. Study Identification

Unique Protocol Identification Number
NCT01388231
Brief Title
Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice
Official Title
Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice (SophoPrax)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden
Collaborators
Goethe University, University of Göttingen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
social phobia, cognitive-behavioral therapy, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juergen Hoyer, Prof. Dr.
Phone
35146336986
Ext
+49
Email
hoyer@psychologie.tu-dresden.de
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen C Crawcour, Dr.
Phone
35146336964
Ext
+49
Email
crawcour@psychologie.tu-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juergen Hoyer, Prof. Dr.
Organizational Affiliation
Technische Universität Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinical services and day clinic center Technical University Dresden (IAP-TUD)
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01187
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juergen Hoyer, Prof. Dr.
Phone
35146336986
Ext
+49
Email
hoyer@psychologie.tu-dresden.de
First Name & Middle Initial & Last Name & Degree
Stephen C Crawcour, Dr.
Phone
35146336964
Ext
+49
Email
crawcour@psychologie.tu-dresden.de
First Name & Middle Initial & Last Name & Degree
Juergen Hoyer, Prof. Dr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
18852500
Citation
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.
Results Reference
background
PubMed Identifier
22647314
Citation
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.
Results Reference
derived

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

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