The social phobia psychotherapy research network
| ISRCTN | ISRCTN53517394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53517394 |
| Protocol serial number | N/A |
| Sponsor | Ministry for Development and Research (Bundesministerium für Bildung und Forschung [BMBF]) (Germany) |
| Funder | Bundesministerium für Bildung und Forschung |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled multicenter trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The social phobia psychotherapy research network |
| Study acronym | SOPHO-NET |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Social phobia (social anxiety disorder) |
| Intervention | Manualized short-term psychodynamic psychotherapy (STPP) versus manualized cognitive-behavioral therapy (CBT) |
| Intervention type | Other |
| 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 |
| Key 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) |
| Completion date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 512 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 01/10/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
von Sieboldstrasse 5
Goettingen
37075
Germany
37075
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/08/2016: Publication reference added.
