Social Phobia Mental and Behavioural Disorders Phobias
Conditions
Interventions
Patients suffering from social phobia who are referred to the Centre for Anxiety Disorders and Trauma at the Maudsley Hospital will be invited to participate in the trial. Patients who agree to be inc
Sponsors
King's College London and the South London and Maudsley NHS Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: To be included in the trial, patients must meet the following criteria: 1. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (American Psychiatric Association, 1994) criteria for social phobia 2. Duration of at least six months 3. Social phobia considered to be the patient's main problem 4. Age 18 to 65 years 5. No psychotropic medication or on a stable dose for at least two months without symptomatic improvement and willing to keep dosage constant during the trial 6. Agree not to start any additional non-protocol treatment during the trial 7. Willing to accept random allocation
Exclusion criteria
Exclusion criteria: Patients who meet the inclusion criteria will be excluded if they also met the following criteria: 1. Current alcohol or substance dependency (abuse but not dependency is acceptable) 2. Current or past psychosis 3. Borderline personality disorder (other personality disorders are not a reason for exclusion) 4. Unable to read English 5. Social phobia previously treated with an adequate course of an appropriate course of cognitive behaviour therapy or exposure therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure for the trial is a social phobia composite measure that is created by combining scores from seven independent assessor and patient scales that are well validated measures of social phobia related symptomatology. Scores on each scale are standardised (M = 0, SD = 1) across pre-treatment and post-treatment assessments by converting to Z scores. The composite at each assessment occasion is the mean of the Z scores on that occasion. This procedure has been used in our last two social phobia trials as well as in other trials in the field. The seven scales that make up the social phobia composite are: 1. The mean assessor rating of social phobia related fear and avoidance from the anxiety disorders interview schedule for DSM-IV 2. Patient completed Social Phobia Scale 3. The Social Interaction Anxiety Scale 4. The Liebowitz Social Anxiety Scale 5. The Social Phobia and Anxiety Inventory 6. The Fear of Negative Evaluation Scale 7. The Social Phobia Weekly Summary Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. General mood (assessed by the Beck Anxiety Inventory and the Beck Depression Inventory) and Disability (assessed by the Sheehan Disability Scales) 2. The proportion of patients who continue to meet diagnostic criteria for social phobia at post-treatment and follow-up and the proportion of patients who continue to meet diagnostic criteria for avoidant personality disorder at 12 month follow-up | — |
Countries
United Kingdom
Outcome results
None listed