performance anxiety social anxiety disorder social phobia speech anxiety
Conditions
Interventions
Participants will be randomly allocated to receive exposure therapy plus
testosterone (sublingual, 0.50 mg) or exposure therapy plus identical looking
placebo. Testosterone/Placebo will be administe
Sponsors
ProPersona (Nijmegen)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Woman, 18-45 years old - Social Anxiety Disorder (SAD) as established with a structured interview (MINI), and with speech anxiety as primary fear - Self reported SAD symptoms above clinical cut-off (score > 30 on the Liebowitz Social Anxiety Scale)
Exclusion criteria
Exclusion criteria: - Prior non response to exposure therapy (i.c. speech exposure) for SAD symptoms, as defined by the patient*s report of receiving specific and regular exposure assignments as part of previous therapy. - Entry of patients with other mood or anxiety disorders will be permitted in order to increase accrual of a clinically relevant sample; however in cases where SAD is not judged to be the predominant disorder, participants will not be eligible. - Psychosis or delusion disorders (current or in the past) - Patients with significant suicidal ideations or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from participation and referred for appropriate clinical intervention. - Mental retardation - Substance abuse or alcohol dependence - Somatic illness - Women of childbearing potential that are not willing to use an active form of birth-control during the trial - Pregnancy or lactation - Infertility - Antipsychotic medication - Participants that use antidepressants or benzodiazepines will not be excluded, but have to be on a stable dose for at least 6 weeks prior to enrollment. - Insufficient ability to speak and write Dutch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our main outcome is reduction of social anxiety disorder symptoms, as assessed by Subjective Units of Distress (SUDs). participants will provide fear ratings (ranging from 0; no fear to 100 most anxiety imaginable) prior and during both exposure sessions. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Subsequently, outcome will be assessed by other self-report questionnaires (Liebowitz Social Anxiety Scale (LSAS), Social Phobia Scale (SPS), Social Phobia Anxiety Inventory (SPAI), Beck Depression Inventory (BDI), Visual Analogue Scales (SUDs) and Harm Expectancy (HE) ratings. - Video-tapes of participants* performance during each exposure session will be rated with the Social Performance Rating Scale (SPRS), which is an evaluation of behavioral indicators of anxiety. - Both exposure sessions will be audio-recorded and transcribed, speech will be rated and analyzed by the Linguistic Inquiry and Word count (LIWC). -In addition, we will assess automatic socio-anxiolytic behavior tendencies by means of implicit measures, e.g. approach/aviodance and risktaking behaviour. | — |
Countries
Netherlands
Outcome results
None listed