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
Protocol serial number	01GV0903
Sponsor	German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Funder	German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)

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 of protocol

Not provided at time of registration

Contact information

Dr Klaus-Thomas Kronmüller
Scientific

Voßstraße 4
Heidelberg
69115
Germany

Phone	+49 (0)62 21565938
Email	klaus.kronmueller@med.uni-heidelberg.de

Study information

Primary study design	Interventional
Study design	Multicentre randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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 objectives	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
Health condition(s) or problem(s) studied	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(s)	Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) at post-assessment (and 1 year follow-up)
Key secondary outcome measure(s)	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.
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	126
Key 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
Key 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
Date of first enrolment	01/01/2010
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Germany

Study participating centre

Voßstraße 4

Heidelberg
69115
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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes