Hormones and Social Anxiety Disorder Treatment

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482805
• Other study ID #: SAD - Hormones
• Status: Completed
• Phase: N/A
• First received: June 17, 2015
• Last updated: October 19, 2017
• Start date: July 2015
• Est. completion date: April 2017

Study information

• Verified date: October 2017
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Exposure therapy for social anxiety disorder

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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