Hormones and Social Anxiety Disorder Treatment

NCT ID: NCT02482805

Last Updated: 2017-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-04-30

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.

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Power Posing

Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Exposure therapy for social anxiety disorder

Submissive Posing

Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Exposure therapy for social anxiety disorder

Rest

Individuals rest (no postures) for 2 minutes prior to exposure therapy.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Exposure therapy for social anxiety disorder

Interventions

Cognitive Behavioral Therapy

Exposure therapy for social anxiety disorder

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Texas at Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

SAD - Hormones

Identifier Type: -

Identifier Source: org_study_id