Condition category
Mental and Behavioural Disorders
Date applied
22/06/2006
Date assigned
26/07/2006
Last edited
15/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Falk Leichsenring

ORCID ID

Contact details

von Sieboldstrasse 5
Goettingen
37075
Germany
+49 (0)55 15005278
Fleichs@gwdg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The social phobia psychotherapy research network

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

Ethics Committee of the Medical Faculty of the University of Goettingen, 06/12/2006

Study design

Randomized controlled multicenter trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Social phobia (social anxiety disorder)

Intervention

Manualized short-term psychodynamic psychotherapy (STPP) versus manualized cognitive-behavioral therapy (CBT)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/10/2006

Overall trial end date

01/10/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

512

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

Trial participating centre

von Sieboldstrasse 5
Goettingen
37075
Germany

Sponsor information

Organisation

Ministry for Development and Research (Bundesministerium für Bildung und Forschung [BMBF]) (Germany)

Sponsor details

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

Sponsor type

Government

Website

http://www.bmbf.de

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24365384
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26785255

Publication citations

  1. Results

    Sonntag M, Konnopka A, Leichsenring F, Salzer S, Beutel ME, Herpertz S, Hiller W, Hoyer J, Joraschky P, Nolting B, Pöhlmann K, Stangier U, Strauss B, Willutzki U, Wiltink J, Leibing E, König HH, Reliability, validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with social phobia., Health Qual Life Outcomes, 2013, 11, 215, doi: 10.1186/1477-7525-11-215.

  2. Results

    Wiltink J, Hoyer J, Beutel ME, Ruckes C, Herpertz S, Joraschky P, Koranyi S, Michal M, Nolting B, Pöhlmann K, Salzer S, Strauss B, Leibing E, Leichsenring F, Do Patient Characteristics Predict Outcome of Psychodynamic Psychotherapy for Social Anxiety Disorder?, PLoS One, 2016, 11, 1, e0147165, doi: 10.1371/journal.pone.0147165.

Additional files

Editorial Notes

15/08/2016: Publication reference added.