Social PhobiaPhase 2/3NCT01388231
Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice
A Phase 2/3 study testing CBT-Manualized Intervention and CBT-Treatment as Usual in people with Social Phobia, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The study aims at examining the effects of additional training in manualized cognitive-behavioral therapy (CBT) on outcome in routine psychotherapy for social phobia. The investigators will investigate how CBT, specifically the treatment procedures and manuals proposed by Clark and Wells (1995), can be transferred… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Social Phobia
- What is being tested?
- CBT-Manualized Intervention and CBT-Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Jun 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary diagnosis of Social Phobia (SCID-I)
- Liebowitz Social Anxiety Inventory Scale (LSAS) equal to or greater than 30
- age between 18 and 70 years
Who cannot join
- psychotic disorder, risk of self-harm, acute substance related disorders, personality disorders except for Cluster C (SCID-II)
- organic mental disorder
- severe medical conditions
- ongoing psychotherapy or initiation
- psychopharmacological treatment
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Outpatient clinical services and day clinic center Technical University Dresden (IAP-TUD)
Dresden, Saxony, 01187
Juergen Hoyer, Prof. Dr., 35146336986 ext. +49, hoyer@psychologie.tu-dresden.de
Stephen C Crawcour, Dr., 35146336964 ext. +49, crawcour@psychologie.tu-dresden.de
About this study
Official title: Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice (SophoPrax)
The study aims at examining the effects of additional training in manualized cognitive-behavioral therapy (CBT) on outcome in routine psychotherapy for social phobia. The investigators will investigate how CBT, specifically the treatment procedures and manuals proposed by Clark and Wells (1995), can be transferred from controlled trials into the less structured setting of routine clinical care, and whether the health care system benefits from such developments. Private practitioners (N=36) will be randomized to one of two treatment conditions (i.e., training in manualized CBT vs. treatment as usual without specific training). The investigators plan to enroll 160 patients (80 per condition) to be able to detect differences of d=.50 between conditions at 1-beta=.80, given the drop-out rate of 25% (N=116 completers; N=58 per condition). The study is genuinely designed to promote faster and more widespread dissemination of effective interventions. The following research questions can be examined: (1) Can manualized CBT be successfully implemented into routine outpatient care? (2) Will the new methods lead to an improvement of treatment courses aned outcomes? (3) Will treatment effects in routine psychotherapeutic treatments be comparable to those of the controlled, strictly manualized treatment of the main study?
- Conditions
- Social Phobia
- Being tested
- CBT-Manualized Intervention, CBT-Treatment as Usual
- Keywords
- social phobia, cognitive-behavioral therapy, treatment
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-Manualized InterventionBehavioural
Cognitive-behavioral therapy (CBT) for social phobia following the Clark and Wells (1995) model of social phobia.
CBT-Treatment as UsualBehavioural
Cognitive-behavioral therapy for social phobia following no specific model.
| Study group | Role | What they receive |
|---|---|---|
| Manualized CBT Group | Active comparator | The present group is comprised of clinical practitioners performing cognitive-behavioral therapy (CBT) on social phobic patients after receiving structured clinical training on the treatment of social phobia based on the Clark and Wells (1995) model. Receives: Behavioral: CBT-Manualized Intervention |
| CBT Group -Treatment as Usual | Active comparator | The present group is comprised of clinical practitioners performing cognitive-behavioral therapy (CBT) on social phobic patients, while receiving no structured training in the treatment of social phobia. Receives: Behavioral: CBT-Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Social Phobia Symptoms
Symptom severity will be assessed via the Liebowitz Social Anxiety Scale (LSAS).
Measured: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Secondary outcomes (10)
Diagnostic Status of Social Phobia
Diagnostic status will be assessed via SCID-I.
Measured: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of Symptoms of Social Anxiety (Performance Anxiety)
To further assess symptoms of social anxiety, the Social Phobia Anxiety Inventory (SPAI) will be used.
Measured: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of Symptoms of Social Anxiety (Social Phobic Cognitions)
To further assess cognitive symptoms of social anxiety, the Social Phobic Cognitions Questionnaire will be used.
Measured: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of a Change in Safety Behaviors in Social Anxiety
To further assess safety behaviors in social anxiety the Safety Behaviors Questionnaire will be used.
Measured: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of Other Social Anxiety Symptoms
To further assess symptoms of social anxiety, the Brief Social Phobia Scale(BSPS) will be used.
Measured: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of Symptoms of Depression
To further assess symptoms of depression, the Beck Depression Inventory (BDI), will be employed.
Measured: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of Emotion Regulation
To assess the level of emotion regulation, the Affective Style Questionnaire (ASQ) will be employed.
Measured: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of the Quality of Life
To assess the quality of life in patients, the Quality of Life (QoL) questionnaire will be used.
Measured: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of the Times Missing from Work
The times missing from work will be assessed via a separate questionnaire.
Measured: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of the General Level of Severity of Social Anxiety Symptoms
To get a global impression from the diagnosticitian on the general level of severity of social anxiety symptoms, the Clinical Global Impression scale (CGI) will be used.
Measured: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startSep 2010
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Goethe University, University of Göttingen
- Investigators
- Juergen Hoyer, Prof. Dr., Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388231
- Sponsor's protocol ID
- 01GV1001
- Status last verified
- Jul 2011
- First submitted
- 8 Jun 2011
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leichsenring F, Hoyer J, Beutel M, Herpertz S, Hiller W, Irle E, Joraschky P, Konig HH, de Liz TM, Nolting B, Pohlmann K, Salzer S, Schauenburg H, Stangier U, Strauss B, Subic-Wrana C, Vormfelde S, Weniger G, Willutzki U, Wiltink J, Leibing E. The social phobia psychotherapy research network. The first multicenter randomized controlled trial of psychotherapy for social phobia: rationale, methods and patient characteristics. Psychother Psychosom. 2009;78(1):35-41. doi: 10.1159/000162299. Epub 2008 Oct 14.
PubMed 18852500Crawcour S, Leibing E, Ginzburg D, Stangier U, Wiltink J, Hoyer J. Transfer of manualized CBT for social phobia into clinical practice (SOPHO-PRAX): a study protocol for a cluster-randomized controlled trial. Trials. 2012 May 30;13:70. doi: 10.1186/1745-6215-13-70.
PubMed 22647314
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice (SophoPrax)
- ClinicalTrials.gov ID
- NCT01388231
- Acronym / sponsor ID
- 01GV1001
- Conditions
- Social Phobia
- Keywords
- social phobia, cognitive-behavioral therapy, treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Goethe University, University of Göttingen
- Study start
- Sep 2010
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims at examining the effects of additional training in manualized cognitive-behavioral therapy (CBT) on outcome in routine psychotherapy for social phobia. The investigators will investigate how CBT, specifically the treatment procedures and manuals proposed by Clark and Wells (1995), can be transferred from controlled trials into the less structured setting of routine clinical care, and whether the health care system benefits from such developments. Private practitioners (N=36) will be randomized to one of two treatment conditions (i.e., training in manualized CBT vs. treatment as usual without specific training). The investigators plan to enroll 160 patients (80 per condition) to be able to detect differences of d=.50 between conditions at 1-beta=.80, given the drop-out rate of 25% (N=116 completers; N=58 per condition). The study is genuinely designed to promote faster and more widespread dissemination of effective interventions. The following research questions can be examined: (1) Can manualized CBT be successfully implemented into routine outpatient care? (2) Will the new methods lead to an improvement of treatment courses aned outcomes? (3) Will treatment effects in routine psychotherapeutic treatments be comparable to those of the controlled, strictly manualized treatment of the main study?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manualized CBT Group | Active comparator | Behavioral: CBT-Manualized InterventionThe present group is comprised of clinical practitioners performing cognitive-behavioral therapy (CBT) on social phobic patients after receiving structured clinical training on the treatment of social phobia based on the Clark and Wells (1995) model. |
| CBT Group -Treatment as Usual | Active comparator | Behavioral: CBT-Treatment as UsualThe present group is comprised of clinical practitioners performing cognitive-behavioral therapy (CBT) on social phobic patients, while receiving no structured training in the treatment of social phobia. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary diagnosis of Social Phobia (SCID-I)
- Liebowitz Social Anxiety Inventory Scale (LSAS) equal to or greater than 30
- age between 18 and 70 years
Key exclusion criteria (5 listed)
- psychotic disorder, risk of self-harm, acute substance related disorders, personality disorders except for Cluster C (SCID-II)
- organic mental disorder
- severe medical conditions
- ongoing psychotherapy or initiation
- psychopharmacological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-Manualized InterventionCognitive-behavioral therapy (CBT) for social phobia following the Clark and Wells (1995) model of social phobia. | Behavioural | Manualized CBT Group |
| CBT-Treatment as UsualCognitive-behavioral therapy for social phobia following no specific model. | Behavioural | CBT Group -Treatment as Usual |
Primary outcome
Severity of Social Phobia Symptoms
Time frame: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Symptom severity will be assessed via the Liebowitz Social Anxiety Scale (LSAS).
10 secondary outcomes
Diagnostic Status of Social Phobia
Time frame: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of Symptoms of Social Anxiety (Performance Anxiety)
Time frame: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of Symptoms of Social Anxiety (Social Phobic Cognitions)
Time frame: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of a Change in Safety Behaviors in Social Anxiety
Time frame: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of Other Social Anxiety Symptoms
Time frame: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of Symptoms of Depression
Time frame: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of Emotion Regulation
Time frame: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of the Quality of Life
Time frame: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of the Times Missing from Work
Time frame: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Assessment of the General Level of Severity of Social Anxiety Symptoms
Time frame: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
- Background: PubMed 18852500Leichsenring F, Hoyer J, Beutel M, Herpertz S, Hiller W, Irle E, Joraschky P, Konig HH, de Liz TM, Nolting B, Pohlmann K, Salzer S, Schauenburg H, Stangier U, Strauss B, Subic-Wrana C, Vormfelde S, Weniger G, Willutzki U, Wiltink J, Leibing E. The social phobia psychotherapy research network. The first multicenter randomized controlled trial of psychotherapy for social phobia: rationale, methods and patient characteristics. Psychother Psychosom. 2009;78(1):35-41. doi: 10.1159/000162299. Epub 2008 Oct 14.
- Derived from this study: PubMed 22647314Crawcour S, Leibing E, Ginzburg D, Stangier U, Wiltink J, Hoyer J. Transfer of manualized CBT for social phobia into clinical practice (SOPHO-PRAX): a study protocol for a cluster-randomized controlled trial. Trials. 2012 May 30;13:70. doi: 10.1186/1745-6215-13-70.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juergen Hoyer, Prof. Dr. principal investigator
Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CBT-Manualized Intervention and CBT-Treatment as Usual in people with Social Phobia, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juergen Hoyer, Prof. Dr. (35146336986 ext. +49, hoyer@psychologie.tu-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Social Phobia Symptoms (time frame: Data will be collected for an expected treatment period of 30 weeks in average (corresponding to an expected average of n=25 sessions), at treatment completion, at 6 and 12 months post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01388231, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2011.