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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:
Sponsor: Technische Universität Dresden

Current Primary Outcome: Severity of Social Phobia Symptoms [ 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. ]

Symptom severity will be assessed via the Liebowitz Social Anxiety Scale (LSAS).


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Technische Universität Dresden

Dates:
Date Received: June 8, 2011
Date Started: September 2010
Date Completion: June 2013
Last Updated: July 7, 2011
Last Verified: July 2011