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The social phobia psychotherapy research network
ISRCTN ISRCTN53517394
DOI 10.1186/ISRCTN53517394
ClinicalTrials.gov identifier
EudraCT number
Public title The social phobia psychotherapy research network
Scientific title
Acronym SOPHO-NET
Serial number at source N/A
Study hypothesis Differential efficacy of short-term psychodynamic psychotherapy (STPP) and cognitive-behavioral therapy (CBT) in social phobia therapy - named hypothesis A1

The first add-on study (named C1) of this multicentre trial will be studying genetic polymorphisms in patients with social phobia who are treated with STPP and CBT.

The second add-on study (named C2) of this multicentre trial will be studying the neural functional and structural changes in patients with social phobia who are treated with STPP and CBT.

The third add-on study (named C3) of this multicentre trial will be studying the attachment characteristics as differential predictors of treatment outcome in 128 patients with social phobia who are treated with STPP and CBT.
Lay summary Not provided at time of registration
Ethics approval Approved by the Ethics Committee of the Medical Faculty of the University of Goettingen on 06/12/2006
Study design Randomized controlled multicenter trial
Countries of recruitment Germany
Disease/condition/study domain Social phobia (social anxiety disorder)
Participants - inclusion criteria 1. Diagnosis of social phobia (SP) according to the Structured Interview for Diagnostic and Statistical Manual of Mental Disorders - fourth edition [SCID-I DSM-IV]) and primary diagnosis of social phobia according to the Liebowitz Social Anxiety Scale >302
2. Aged 18 to 59 versus 60 to 70 years
4. Participants must be made up of 60% women; 40% men
Participants - exclusion criteria 1. Psychotic disorder
2. Risk of self-harm
3. Acute substance related disorder
4. Personality disorders except for cluster C
5. Organic mental disorder
6. Severe medical conditions
7. Concurrent psychotherapeutic or psychopharmacological treatment
Anticipated start date 01/10/2006
Anticipated end date 01/10/2009
Status of trial Completed
Patient information material
Target number of participants 512
Interventions Manualized short-term psychodynamic psychotherapy (STPP) versus manualized cognitive-behavioral therapy (CBT)
Primary outcome measure(s) For A1, primary outcome is no diagnosis of SP according to the SCID-I DSM-IV and the Liebowitz Social Anxiety Scale

For C1, the primary outcome will be, that the psychotherapy outcome is associated with genetic variation in the serotonin transporter (SERT) gene (directed: L12 higher pre-post difference in the Liebowitz Social Anxiety Scale [LSAS])

For C2, primary outcomes will include normalisation of neural structural and functional abnormalities after successful treatment

For C3, primary outcomes will be whether patients reveal a secure organized attachment; representation will reach a better outcome than those with insecure features and\or disorganized states of mind
Secondary outcome measure(s) For A1, secondary outcomes will include:
1. Social anxiety (Social Phobia and Anxiety Inventory [SPAI])
2. Depression (Beck Depression Inventory [BDI])
3. Interpersonal problems (IIP)
4. Self-image
5. Quality of life or social functioning (short-form-12 questionnaire [SF-12])
6. Costs and utilities of the treatments

For C1, the secondary outcome will be, that the severity of social phobia is linked with genetic variation in SERT gene (directed: S10 higher LSAS at baseline)

For C2 secondary outcome will include specificity of neural structural and functional abnormalities in social phobia

For C3, secondary outcome will include whether a self-reported attachment will significantly change after successful therapy indicating increased security. This will be tested by using the Experiences in Close Relationships-Revised (ECR-R) instrument within the entire sample (n = 512)
Sources of funding Ministry for Development and Research (Ministerium für Bildung und Forschung)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24365384
Contact name Prof  Falk  Leichsenring
  Address von Sieboldstrasse 5
  City/town Goettingen
  Zip/Postcode 37075
  Country Germany
  Tel +49 (0)55 15005278
  Fax +49 (0)55 1500 5300
  Email Fleichs@gwdg.de
Sponsor Ministry for Development and Research (Bundesministerium für Bildung und Forschung [BMBF]) (Germany)
  Address Hannoversche Strasse 28-30
  City/town Berlin
  Zip/Postcode 10115 Berlin
  Country Germany
  Tel +49 (0)18 88570
  Fax +49 (0)18 8857 83601
  Email Detlef.Boecking@dlr.de
  Sponsor website: http://www.bmbf.de
Date applied 22/06/2006
Last edited 25/07/2014
Date ISRCTN assigned 26/07/2006
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