93 Social Avoidance and Testosterone Enhanced Exposure Efficacy in Women with Social Anxiety Disorder Materials and Methods Participants A complete description of the sample and procedures has been provided elsewhere (Hutschemaekers et al., 2021) and in Chapter 5 – Appendix 1. In short, the sample included 55 females suffering from SAD (Mage = 23.31, SD = 5.63, range = 18–43). Participants were recruited at an outpatient clinic specialized in anxiety disorders, at the Radboud University Nijmegen, and from the community. We focused exclusively on females because the pharmacodynamics of the currently used testosterone administration methods have as yet been established in females only (Tuiten et al., 2000). Exclusion criteria were: A) Prior non-response to speech exposure therapy for SAD, B) other predominant emotional disorder(s) C) Psychosis or delusion disorders (current or lifetime), D) Significant suicidal ideations or behaviors within 6 months prior to screening, E) Intellectual developmental disorder , F) Substance or alcohol dependence, G) Somatic illness, H) Females unwilling to use an active form of birth control during the trial, I) pregnancy or lactation, J) Infertility, K) Antipsychotic medication, L) Unstable dose of Antidepressants or Benzodiazepines within 6 weeks prior to enrollment, M) Insufficient proficiency of Dutch language, N) Use of contraceptive containing cyproterone acetate. Ethical approval for this study was granted by the local Review Board (Arnhem-Nijmegen). Medication and randomization Participants were randomly assigned to testosterone (T) or placebo (P) treatment. T was suspended in a clear solution (0.5 ml) with 0.5 mg hydroxypropyl-beta-cyclodextrin, 0.005 ml ethanol 96%, and distilled water. P contained the same ingredients, except the T. Participants held the liquid under their tongue for 60 seconds (4 hours prior to the first exposure). Participants and researchers were blind to treatment condition until completion of the primary outcome analyses of the parent trial. Exposure intervention Participants received 2 public speaking exposure sessions of 90 minutes, at two separate days, based on the protocol developed by Rodebaugh, Levinson, and Lenze (2013). The second session, one week later, followed the same protocol as the first session without drug administration. Therapists were advanced Bachelor- or Master-level psychology students trained and supervised by authors M.H. and M.K. Adherence to the protocol was checked during supervisions and deviations from the protocol were reported by the therapists. Adherence was good as 96.3% of the sessions was performed according to the protocol. 5
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