Hormones and Social Anxiety Disorder Treatment

Study Overview
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Brief Summary
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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.

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

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Power Posing<br>Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy. | Behavioral: Cognitive Behavioral Therapy<br>* Exposure therapy for social anxiety disorder<br>|
| Experimental: Submissive Posing<br>Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy. | Behavioral: Cognitive Behavioral Therapy<br>* Exposure therapy for social anxiety disorder<br>|
| Experimental: Rest<br>Individuals rest (no postures) for 2 minutes prior to exposure therapy. | Behavioral: Cognitive Behavioral Therapy<br>* Exposure therapy for social anxiety disorder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LSAS-performance Subscale | 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. | Scores at 1 week post-treatment | 
| Subjective Units of Distress Scale (SUDs) | 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. | Scores at 1 week post-treatment | 
| Salivary Testosterone Levels | Saliva sample taken before posture manipulation and 20 minutes after. Outcome is the change from pre- to post-manipulation in testosterone levels. | Baseline and 20 minutes after posture manipulation |