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

Overview

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?

Full Title of Study: “Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice (SophoPrax)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: June 2013

Interventions

  • Behavioral: CBT-Manualized Intervention
    • Cognitive-behavioral therapy (CBT) for social phobia following the Clark and Wells (1995) model of social phobia.
  • Behavioral: CBT-Treatment as Usual
    • Cognitive-behavioral therapy for social phobia following no specific model.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Technische Universität Dresden
  • Collaborator
    • Goethe University
  • Provider of Information About this Clinical Study
    • Prof. Dr. Juergen Hoyer, Dresden University of Technology
  • Overall Official(s)
    • Juergen Hoyer, Prof. Dr., Principal Investigator, Technische Universität Dresden
  • Overall Contact(s)
    • Juergen Hoyer, Prof. Dr., 35146336986, hoyer@psychologie.tu-dresden.de

References

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.

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