Social Phobia
Conditions
Keywords
social phobia, cognitive-behavioral therapy, treatment
Brief 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 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?
Interventions
BEHAVIORALCBT-Manualized Intervention
Cognitive-behavioral therapy (CBT) for social phobia following the Clark and Wells (1995) model of social phobia.
BEHAVIORALCBT-Treatment as Usual
Cognitive-behavioral therapy for social phobia following no specific model.
Sponsors
Goethe University
University of Göttingen
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Social Phobia Symptoms | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Symptoms of Social Anxiety (Performance Anxiety) | 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. | To further assess symptoms of social anxiety, the Social Phobia Anxiety Inventory (SPAI) will be used. |
| Assessment of Symptoms of Social Anxiety (Social Phobic Cognitions) | 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. | To further assess cognitive symptoms of social anxiety, the Social Phobic Cognitions Questionnaire will be used. |
| Assessment of a Change in Safety Behaviors in Social Anxiety | 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. | To further assess safety behaviors in social anxiety the Safety Behaviors Questionnaire will be used. |
| Assessment of Other Social Anxiety Symptoms | 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. | To further assess symptoms of social anxiety, the Brief Social Phobia Scale(BSPS) will be used. |
| Diagnostic Status of Social Phobia | 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. | Diagnostic status will be assessed via SCID-I. |
| Assessment of Emotion Regulation | 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. | To assess the level of emotion regulation, the Affective Style Questionnaire (ASQ) will be employed. |
| Assessment of the Quality of Life | 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. | To assess the quality of life in patients, the Quality of Life (QoL) questionnaire will be used. |
| Assessment of the Times Missing from Work | 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. | The times missing from work will be assessed via a separate questionnaire. |
| Assessment of the General Level of Severity of Social Anxiety Symptoms | 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. | 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. |
| Assessment of Symptoms of Depression | 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. | To further assess symptoms of depression, the Beck Depression Inventory (BDI), will be employed. |
Countries
Germany
Contacts
Primary ContactJuergen Hoyer, Prof. Dr.
Backup ContactStephen C Crawcour, Dr.
Outcome results
None listed