Enhancement of exposure therapy for social anxiety disorder with testosterone: A randomized placebo controlled clinical trial

Phase 3

Completed

• Conditions: performance anxiety; social anxiety disorder; social phobia; speech anxiety; 10002861

• Registration Number: NL-OMON44812
• Lead Sponsor: ProPersona (Nijmegen)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-08-20
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 54

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our main outcome is reduction of social anxiety disorder symptoms, as assessed<br /><br>by Subjective Units of Distress (SUDs). participants will provide fear ratings<br /><br>(ranging from 0; no fear to 100 most anxiety imaginable) prior and during both<br /><br>exposure sessions.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Subsequently, outcome will be assessed by other self-report questionnaires<br /><br>(Liebowitz Social Anxiety Scale (LSAS), Social Phobia Scale (SPS), Social<br /><br>Phobia Anxiety Inventory (SPAI), Beck Depression Inventory (BDI), Visual<br /><br>Analogue Scales (SUDs) and Harm Expectancy (HE) ratings.<br /><br>- Video-tapes of participants* performance during each exposure session will be<br /><br>rated with the Social Performance Rating Scale (SPRS), which is an evaluation<br /><br>of behavioral indicators of anxiety.<br /><br>- Both exposure sessions will be audio-recorded and transcribed, speech will be<br /><br>rated and analyzed by the Linguistic Inquiry and Word count (LIWC).<br /><br>-In addition, we will assess automatic socio-anxiolytic behavior tendencies by<br /><br>means of implicit measures, e.g. approach/aviodance and risktaking behaviour. </p><br>