Social Phobia
Conditions
Interventions
Experimental group: 20 patients with social anxiety disorder on usual pharmacological treatment will have 16 individual sessions of cognitive therapy conducted over 16 weeks. Control group: 20 patient
Behavioural
Sponsors
Instituto de Psiquiatria da UFRJ - IPUB
Instituto D'Or
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: A current principal diagnosis of social anxiety disorder by DSM-5 criteria; A history of at least one unsuccessful adequate pharmacological treatment trials, operationalized as lack of response Clinical Global Impression-improvement scale (CGI-I) greater than or equal to 3, to at least 10 weeks of (i) SSRIs or venlafaxine at adequate dosage; with or without (ii) benzodiazepines (e.g. clonazepam 2 mg/day); A total score on the Liebowitz Social Anxiety Scale (LSAS) of 50 or greater; Man and woman with age of at least 18 years.
Exclusion criteria
Exclusion criteria: Pregnancy, lactation, and women of childbearing potential without accepted forms of contraception; Psychotic disorders, bipolar disorder, mental retardation, a recent history of alcohol or substance abuse or dependence; Severe organic medical disorder; Concurrent use of other psychotropic medications than detailed in inclusion criteria; Current or recent significant suicidality; Any concurrent psychotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the change in symptoms of SAD assessed by independent clinical raters, using the Liebowitz Social Anxiety Scale (LSAS) at pre-treatment and post-treatment. In addition, as a primary outcome measure, Clinical Global Impression improvement scale (CGI-I) will be used for the measurement of overall symptom change at post-treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures of the interventions effects are self-reported clinical symptoms of SAD, depression and anxiety. As self-report measures the Social Phobia Inventory (SPIN), the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI) will be administered. In addition, changes in life quality on a general level will be assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). | — |
Countries
Brazil
Contacts
Public ContactGabriela Bezerra de Menezes
Instituto de Psiquiatria da UFRJ - IPUB
Outcome results
None listed