The social phobia psychotherapy research network
| ISRCTN | ISRCTN53517394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53517394 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/06/2006
- Registration date
- 26/07/2006
- Last edited
- 15/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Falk Leichsenring
Scientific
Scientific
von Sieboldstrasse 5
Goettingen
37075
Germany
| Phone | +49 (0)55 15005278 |
|---|---|
| Fleichs@gwdg.de |
Study information
| Study design | Randomized controlled multicenter trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The social phobia psychotherapy research network |
| Study acronym | SOPHO-NET |
| 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. |
| Ethics approval(s) | Ethics Committee of the Medical Faculty of the University of Goettingen, 06/12/2006 |
| Condition | Social phobia (social anxiety disorder) |
| Intervention | Manualized short-term psychodynamic psychotherapy (STPP) versus manualized cognitive-behavioral therapy (CBT) |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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) |
| Overall study start date | 01/10/2006 |
| Overall study end date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 512 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/10/2006 |
| Recruitment end date | 01/10/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
von Sieboldstrasse 5
Goettingen
37075
Germany
37075
Germany
Sponsor information
Ministry for Development and Research (Bundesministerium für Bildung und Forschung [BMBF]) (Germany)
Government
Government
Hannoversche Strasse 28-30
Berlin
10115 Berlin
Germany
| Phone | +49 (0)18 88570 |
|---|---|
| Detlef.Boecking@dlr.de | |
| Website | http://www.bmbf.de |
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
Bundesministerium für Bildung und Forschung
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/12/2013 | Yes | No | |
| Results article | results | 19/01/2016 | Yes | No |
Editorial Notes
15/08/2016: Publication reference added.
