Performance Anxiety Social Phobia
Conditions
Interventions
After signing the informed consent form and completing the baseline assessment, forty four eligible participants will be randomly assigned to two groups in a one to one ratio using a computer generate
masking will be applied to the evaluators responsible for administering and analyzing the outcome measures, who will remain unaware of the group to which each participant was allocated, while particip
both groups will complete eight individual sessions, delivered weekly and lasting approximately sixty minutes each
in the intervention group receiving exposure therapy using three hundred and sixty degree filmed virtual reality, the first session will include study orientation, psychoeducation about public speakin
from the second to the sixth session, participants will be gradually and repeatedly exposed to three hundred and sixty degree filmed virtual environments related to public speaking situations, includi
Sponsors
Universidade Federal de São Paulo - unifesp - departamento de psicobiologia
Universidade Federal de São Paulo - unifesp - departamento de psicobiologia
Eligibility
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Signing of the Informed Consent Form and the Informed Consent Record for Research Conducted in Virtual Environments; a score greater than or equal to 20 for women and greater than or equal to 18 for men in the public speaking and interaction with authority figures domain of the Social Anxiety Questionnaire for Adults; a total score greater than or equal to 98 for women and greater than or equal to 89 for men on the Social Anxiety Questionnaire for Adults, indicating the presence of social anxiety; age between 18 and 45 years; availability to attend the in person sessions and the follow up assessment; and either no use of psychotropic medication or stable use for at least 3 months with no changes in dosage
Exclusion criteria
Exclusion criteria: Failure to sign the Informed Consent Form and the Informed Consent Record for Research Conducted in Virtual Environments; a score lower than 20 for women and lower than 18 for men in the public speaking and interaction with authority figures domain of the Social Anxiety Questionnaire for Adults; a total score lower than 98 for women and lower than 89 for men on the Social Anxiety Questionnaire for Adults, indicating that the criteria for social anxiety are not met; changes within the previous three months in psychotropic medications used to treat anxiety or mood disorders; current participation in psychotherapy for public speaking anxiety; a current diagnosis of a severe psychiatric disorder, such as a psychotic disorder, bipolar disorder, or a personality disorder associated with severe impairment in social functioning, as assessed using the Structured Clinical Interview for DSM 5; medical conditions that may interfere with cortisol collection or physiological recording; or conditions that preclude the use of a virtual reality headset
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the severity of social anxiety symptoms, as assessed using the Social Anxiety Questionnaire for Adults (CASO). The primary outcome will be determined by the change in the total CASO score from baseline, assessed before the intervention, to post-intervention, assessed after completion of all sessions. Changes in scores will be compared between the virtual reality exposure therapy group and the active control group. Lower post-intervention scores will indicate a reduction in social anxiety symptoms. The primary assessment time point will be post-intervention, and the maintenance of treatment effects will be examined at the three-month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline diagnostic classification of social anxiety disorder, including identification of the performance-only specifier, using the Structured Clinical Interview for DSM-5 Disorders—Clinician Version (SCID-5-CV). The interview will be administered during the first session, before the intervention, by a trained assessor to confirm the presence of social anxiety disorder associated with performance situations, particularly public speaking, and to characterize participants’ baseline diagnostic profile. The findings will be used to determine eligibility and describe the study sample and will not be considered an intervention outcome measure ;Reduction in the severity of social anxiety symptoms, as assessed using the Liebowitz Social Anxiety Scale (LSAS). This secondary outcome will be determined by changes in the total Liebowitz Social Anxiety Scale (LSAS) score across baseline, assessed before the intervention; post-intervention, assessed after completion of all sessions; and the follow-up assessment, conducted three months after completion of the intervention. The scale assesses the severity of fear or anxiety and the frequency of avoidance behaviors across social interaction and performance situations. It is hypothesized that Liebowitz Social Anxiety Scale (LSAS) scores will decrease following the virtual reality exposure therapy sessions, indicating a reduction in the severity of social anxiety symptoms. A greater reduction is expected in the virtual reality exposure therapy group than in the active control group. Post-intervention will be the primary assessment time point for this outcome, whereas the three-month follow-up assessment will be used to examine the maintenance of intervention effects ;Reduction in subjective distress associated with public speaking situations, as assessed using the Subjective Units of Distress Scale (SUDS). This secondary outcome will be determined by changes in Subjective Units of Distress Scale (SUDS) scores across all study sessi | — |
Countries
BR
Contacts
Public ContactCarolina Ortega
Universidade Federal de São Paulo
Outcome results
None listed