Cognitive therapy (CT-A) versus short-term psychodynamic psychotherapy (STPP-A) for social phobia (SP) in adolescents
| ISRCTN | ISRCTN22752528 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22752528 |
| Secondary identifying numbers | 01GV0903 |
- Submission date
- 07/06/2010
- Registration date
- 17/02/2011
- Last edited
- 17/02/2011
- 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
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Klaus-Thomas Kronmüller
Scientific
Scientific
Voßstraße 4
Heidelberg
69115
Germany
| Phone | +49 (0)62 21565938 |
|---|---|
| klaus.kronmueller@med.uni-heidelberg.de |
Study information
| Study design | Multicentre randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | More information is available at vhttp://www.sopho-net.de/ |
| Scientific title | Cognitive therapy (CT-A) versus short-term psychodynamic psychotherapy (STPP-A) for social phobia (SP) in adolescents: a randomised controlled multicentre study |
| Study acronym | SOPHOYOU |
| Study hypothesis | Manualised CT-A and manualised STPP-A are more effective in reducing symptoms of SP than waitlist control condition (WL). In addition, to identify responder and non-responder profiles of CT-A and STPP-A, moderators of treatment outcome will be examined. |
| Ethics approval(s) | Approved by the Ethics Committee of the Medical Faculty of the University of Heidelberg on the 10th of May 2010 |
| Condition | Social Phobia (Social Anxiety Disorder) |
| Intervention | The trial compares 25 sessions (within 16 weeks) of manualised cognitive therapy for adolescents (CT-A) and manualised short-term psychodynamic psychotherapy (STPP-A) with a waitlist (WL) control condition of 16 weeks. In the first 8 weeks bi-weekly individual sessions provide an intensive start. For the remaining 8 weeks CT-A and STPP-A are conducted with 1 weekly session. |
| Intervention type | Other |
| Primary outcome measure | Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) at post-assessment (and 1 year follow-up) |
| Secondary outcome measures | 1. Diagnosis of SP, evaluated by Kiddie-Schedule for Affective Disorders and Schizophrenia (Kiddie-SADS) 2. Remission in Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) 3. Social Phobia and Anxiety Inventory (SPAI) 4. Clinical Global Impression and Improvement Scale (CGI) 5. EuroQuol for Children (EQ-5D) Secondary outcomes will be measured at pre and post-assessment and at 1 year follow-up. |
| Overall study start date | 01/01/2010 |
| Overall study end date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 126 |
| Participant inclusion criteria | 1. Primary diagnosis of Social Phobia according to Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) 2. Aged 14 to 20 years |
| Participant exclusion criteria | 1. Psychotic disorders 2. Substance related disorders 3. Organic mental disorders 4. Attention Deficit Hyperactivity Disorder (ADHD) 5. Post Traumatic Stress DIsorder (PTSD) 6. Suicidal ideation 7. Servere medical contitions 8. Concurrent psychotherapeutic or psychopharmacological treatment 9. IQ <80 |
| Recruitment start date | 01/01/2010 |
| Recruitment end date | 31/12/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
Voßstraße 4
Heidelberg
69115
Germany
69115
Germany
Sponsor information
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Government
Government
Hannoversche Straße 28-30
Berlin
10115
Germany
| Phone | +49 (0)18 88570 |
|---|---|
| Detlef.Boecking@dir.de | |
| Website | http://www.bmbf.de |
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
No information available
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 |
