Condition category
Mental and Behavioural Disorders
Date applied
07/06/2010
Date assigned
17/02/2011
Last edited
17/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.sopho-net.de

Contact information

Type

Scientific

Primary contact

Dr Klaus-Thomas Kronmüller

ORCID ID

Contact details

Voßstraße 4
Heidelberg
69115
Germany
+49 (0)62 21565938
klaus.kronmueller@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01GV0903

Study information

Scientific title

Cognitive therapy (CT-A) versus short-term psychodynamic psychotherapy (STPP-A) for social phobia (SP) in adolescents: a randomised controlled multicentre 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

Approved by the Ethics Committee of the Medical Faculty of the University of Heidelberg on the 10th of May 2010

Study design

Multicentre randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

More information is available at vhttp://www.sopho-net.de/

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Other

Gender

Both

Target number of participants

126

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

Trial participating centre

Voßstraße 4
Heidelberg
69115
Germany

Sponsor information

Organisation

German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)

Sponsor details

Hannoversche Straße 28-30
Berlin
10115
Germany
+49 (0)18 88570
Detlef.Boecking@dir.de

Sponsor type

Government

Website

http://www.bmbf.de

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes