The social phobia psychotherapy research network

Not Applicable

Completed

Conditions: Social phobia (social anxiety disorder)
Mental and Behavioural Disorders
Social anxiety disorder

Registration Number: ISRCTN53517394

Lead Sponsor: Ministry for Development and Research (Bundesministerium für Bildung und Forschung [BMBF]) (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 512

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For A1, primary outcome is no diagnosis of SP according to the SCID-I DSM-IV and the Liebowitz Social Anxiety Scale<br><br>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])<br><br>For C2, primary outcomes will include normalisation of neural structural and functional abnormalities after successful treatment<br><br>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 Measures

Name	Time	Method
For A1, secondary outcomes will include:<br>1. Social anxiety (Social Phobia and Anxiety Inventory [SPAI])<br>2. Depression (Beck Depression Inventory [BDI])<br>3. Interpersonal problems (IIP)<br>4. Self-image<br>5. Quality of life or social functioning (short-form-12 questionnaire [SF-12])<br>6. Costs and utilities of the treatments<br><br>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)<br><br>For C2 secondary outcome will include specificity of neural structural and functional abnormalities in social phobia<br><br> 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)