Testosterone enhancement of exposure therapy in social anxiety disorder

In this randomized placebo controlled trial we will investigate the effects of testosterone on exposure for social anxiety disorder in women. Fifty-two women (age 18-45 years) will be recruited. Eligible participants will i) have a social anxiety disorder as established by a structured interview; ii) have SAD symptoms of at least moderate severity (LSAS >30); iii) be naive to exposure therapy. Participants will be randomly allocated to receive brief standardized exposure plus testosterone (sublingual, 0.50 mg) or exposure plus identical looking placebo. Testosterone/Placebo will be administered 4 hours prior to the first exposure session. Our main outcome is subjective anxiety as assessed with subjective units of distress (SUDs) ratings. In addition, we will assess self-reported social anxiety symptoms (SPS), automatic socio-anxiolytic behavior tendencies by means of implicit measures, fear learning and avoidance behavior by brief computer tasks.

We expect to detect testosterone effects on response to exposure in terms of subjective anxiety and self reported social anxiety symptoms. Additionally we expect testosterone effects on implicit avoidance tendencies. Lastly, Personality traits, feelings of submissiveness/dominance, avoidance behavior on fear learning task, extinction capacity and a proxy of fetal testosterone will be examined exploratory. As such, no hypotheses were formed regarding these possible predictors.

- Baseline assessment

- Exposure session 1 (one week after baseline assessment)

- Exposure session 2 + post exposure assessment (one week after exposure 1)

- Follow-up assessment (four weeks after exposure session 2, online assessment)

Participants will be randomly allocated to receive exposure therapy plus testosterone (sublingual, 0.50 mg) or exposure therapy plus identical looking placebo. Participants will receive two 60 minutes exposure sessions, targeting speech anxiety.

During the first exposure session participants will receive testosterone/Placebo. Testosterone/Placebo will be administered four hours prior to the first exposure session. During the second session participants will receive exposure therapy without testosterone/placebo.