Social anxiety disorder Mental and Behavioural Disorders
Conditions
Interventions
Participants were assessed prior to treatment (week -2) for diagnostic confirmation, consent form completion, assessment of inclusion and exclusion criteria. Potential participants were selected and r
Sponsors
FAPESP - Fundação de Amparo à Pesquisa do Estado de São Paulo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Recruitment occurred at the Anxiety Disorders Program of the Institute of Psychiatry, Sao Paulo University Medical School 2. Participants aged from 18 to 65 years were interviewed first by a clinical psychologists using a protocol specific interview and then by a psychiatrist using the Structured Clinical Interview for DSM-IV 3. Social anxiety disorder had to be the primary diagnosis, with or without comorbid depression 4. Symptom duration had to exceed 1 year
Exclusion criteria
Exclusion criteria: 1. Clinically significant suicidal risk 2. Beck Depression Inventory score greater than or equal to 30 3. Hamilton Depression Rating Scale score greater than or equal to 21 4. Any other primary psychiatric DSM-IV diagnosis 5. Any medical-systemic disease possibly affecting mental condition including epilepsy 6. Intake of more than two units of alcohol/day 7. Current use of antidepressant medications or benzodiazepines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Treatment global clinical response, measured as a score of 1 (very much improved) or 2 (much improved) on the Clinical Global Impression-Improvement scale at week 20 2. Core social symptoms measured using the Scale of Avoidance and Social Discomfort (SASD) at week 20 3. Social skills acquisition, time-by-treatment interaction of the SASD score (week 0 vs week 20) and Multidimensional Scale of Social Expression – Motor Part (M-MSSE) score (week 0 vs week 20) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Final social skills measured using final score in M-MSSE at week 20 2. Final social anxiety symptoms measured using final score in SASD at week 20 3. Social anxiety symptoms measured using Fear of Negative Evaluation (FNE) final score at week 20 and time-by-treatment interaction 4. Global symptoms measured using Clinical Global Impression - severity (CGI–S) final score at week 20 and time-by-treatment interaction 5. Improvement in global symptoms measured using Clinical Global Impression – Improvement (CGI–I) final score at week 20 6. Anxiety symptoms measured using Hamilton Anxiety Rating Scale (HAM-A) final score at week 20 and time-by-treatment interaction 7. Depressive symptoms measured using Hamilton Depression Rating Scale (HAM-D) final score at week 20 and time-by-treatment interaction 8. Depressive symptoms as measured using Beck Depression Inventory (BDI) final score at week 20 and time-by-treatment interaction 9. Safety assessed using the SAFTEE questionnaire at the basal visit and at every visit thereafter | — |
Countries
Brazil
Outcome results
None listed