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

Study Overview
=================
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?

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

Conditions
-----------------
Social Phobia

Intervention / Treatment
-----------------
* Behavioral: CBT-Manualized Intervention
* Behavioral: CBT-Treatment as Usual


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manualized CBT Group<br>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<br>* Cognitive-behavioral therapy (CBT) for social phobia following the Clark and Wells (1995) model of social phobia.<br>|
| Active Comparator: CBT Group -Treatment as Usual<br>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<br>* Cognitive-behavioral therapy for social phobia following no specific model.<br>|

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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
social phobia, cognitive-behavioral therapy, treatment