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OpenTrials
Completed

NCT Number: NCT02482805

Hormones and Social Anxiety Disorder Treatment

The purpose of this study is to determine whether power posing (i.e., holding poses associated with dominance and power), compared to submissive posing or rest, prior to exposure therapy for social anxiety disorder: 1) leads to a temporary increase in testosterone levels and/or 2) facilitates exposure therapy outcomes.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at Austin

Austin, Texas, 78712, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients between the ages of 18 to 70 years of age with a primary psychiatric diagnosis (designated by the patient as the most important source of current distress) of social anxiety disorder as defined by DSM-5 criteria, with fear of public speaking endorsed as a primary concern.
  • Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol.

Exclusion criteria

  • Current use of testosterone enhancing products (i.e., gels, creams, or injections)
  • A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders; organic brain syndrome, mental retardation or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance or alcohol abuse or dependence (other than nicotine) in the last 6 months.
  • 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.
  • Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
  • Patients using psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) must be on a stable dose for three weeks prior to initiation of randomized treatment.
  • Significant personality dysfunction likely to interfere with study participation.
  • Patients with a current or past history of seizures.
  • Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the SAD is excluded. Prohibited psychotherapy includes CBT or psychodynamic therapy focusing on exploring specific, dynamic causes of the phobic symptomatology and providing management skills. General supportive therapy initiated > 3 months prior is acceptable.
  • Prior non-response to adequately delivered exposure (i.e., as defined by the patient's report of receiving specific and regular exposure assignments as part of a previous treatment).
  • Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
  • Subjects with back pain issues or medical conditions that would make it difficult to hold posture manipulations.
  • Insufficient command of the English language.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

Exposure therapy for social anxiety disorder

Primary outcomes

  1. LSAS-performance Subscale

    Time frame: Scores at 1 week post-treatment

    Liebowitz Social Anxiety Scale (LSAS)-Performance Subscale at pre- and 1-week post-treatment.

    The Liebowitz Social Anxiety Scale (LSAS) - Performance Subscale is a subscale of a common measure of social anxiety symptom severity. This subscale consists of only 13 (of the total 24) items related to performance situations. Participants rate both their fear (0 to 3) and avoidance (0 to 3) of these 13 situations, where higher scores indicate worse social anxiety severity. The minimum possible score on this subscale is 0 and the maximum possible score is 78.

  2. Subjective Units of Distress Scale (SUDs)

    Time frame: Scores at 1 week post-treatment

    Peak (max) SUDS ratings (0 to 100 scale) during treatment exposure and 1 week post-treatment exposure.

    Peak Subjective Units of Distress Scale (SUDS) is the maximum amount of fear experienced rated on a 0 to 100 point scale, where 0 indicates no anxiety and 100 indicates the maximum level of anxiety.

  3. Salivary Testosterone Levels

    Time frame: Baseline and 20 minutes after posture manipulation

    Saliva sample taken before posture manipulation and 20 minutes after. Outcome is the change from pre- to post-manipulation in testosterone levels.

Sponsors and collaborators

Lead sponsor

Jasper A. Smits

Other

Registry information

Official study title

Effect of Hormones on Response to Exposure Therapy for Social Anxiety Disorder

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 26, 2015
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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