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

Phase 2

• Conditions: Social Phobia
• Interventions: Behavioral: CBT-Manualized Intervention; Behavioral: CBT-Treatment as Usual

• Registration Number: NCT01388231
• Lead Sponsor: Technische Universität Dresden

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-06-08
• Status Verified: 2011-07
• Study First Submitted QC: 2011-07-04
• Study First Posted: 2011-07-06
• Last Update Submitted: 2011-07-07
• Last Update Posted: 2011-07-08
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manualized CBT Group	CBT-Manualized Intervention	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.
CBT Group -Treatment as Usual	CBT-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.

Primary Outcome Measures

Name	Time	Method
Severity of Social Phobia Symptoms	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

Name	Time	Method
Diagnostic Status of Social Phobia	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)	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)	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	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	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	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	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	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	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	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.

Trial Locations

Locations (1)

Outpatient clinical services and day clinic center Technical University Dresden (IAP-TUD); 🇩🇪 Dresden, Saxony, Germany