Hormones and Social Anxiety Disorder Treatment

NCT02482805 | Completed Results DMC

• 1 other identifier: SAD - Hormones
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Power Posing

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy

Submissive Posing

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy

Rest

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Exposure therapy for social anxiety disorder

Power Posing; Rest; Submissive Posing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Michelle Davis
• Organization: University of Texas at Austin

michelledavis@utexas.edu

214-470-1371

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 26, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: November 24, 2017
• Results First Posted: October 16, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)