Clinical trial NCT02482805: Hormones and Social Anxiety Disorder Treatment
Official title: Effect of Hormones on Response to Exposure Therapy for Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: LSAS-performance Subscale
timeFrame: Scores at 1 week post-treatment
measure: Subjective Units of Distress Scale (SUDs)
timeFrame: Scores at 1 week post-treatment
measure: Salivary Testosterone Levels
timeFrame: Baseline and 20 minutes after posture manipulation
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References: