Clinical trial NCT01388231: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Social Phobia
Keywords: social phobia, cognitive-behavioral therapy, treatment
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Goethe University
name: University of Göttingen
First posted: 2011-07-06
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


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

Primary outcomes:
measure: Severity of Social Phobia Symptoms
timeFrame: 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 outcomes:
measure: Diagnostic Status of Social Phobia
timeFrame: 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.
measure: Assessment of Symptoms of Social Anxiety (Performance Anxiety)
timeFrame: 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.
measure: Assessment of Symptoms of Social Anxiety (Social Phobic Cognitions)
timeFrame: 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.
measure: Assessment of a Change in Safety Behaviors in Social Anxiety
timeFrame: 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.
measure: Assessment of Other Social Anxiety Symptoms
timeFrame: 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.
measure: Assessment of Symptoms of Depression
timeFrame: 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.
measure: Assessment of Emotion Regulation
timeFrame: 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.
measure: Assessment of the Quality of Life
timeFrame: 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.
measure: Assessment of the Times Missing from Work
timeFrame: 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.
measure: Assessment of the General Level of Severity of Social Anxiety Symptoms
timeFrame: 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.
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Outpatient clinical services and day clinic center Technical University Dresden (IAP-TUD)
state: Saxony
Study officials:
affiliation: Technische Universität Dresden
name: Juergen Hoyer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.