Back to resultsHormones and Social Anxiety Disorder Treatment
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder
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.
Sites / Locations
- University of Texas at Austin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Power Posing
Submissive Posing
Rest
Arm Description
Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.
Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.
Individuals rest (no postures) for 2 minutes prior to exposure therapy.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02482805
First Posted
June 17, 2015
Last Updated
October 19, 2017
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT02482805
Brief Title
Hormones and Social Anxiety Disorder Treatment
Official Title
Effect of Hormones on Response to Exposure Therapy for Social Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Power Posing
Arm Type
Experimental
Arm Description
Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.
Arm Title
Submissive Posing
Arm Type
Experimental
Arm Description
Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.
Arm Title
Rest
Arm Type
Experimental
Arm Description
Individuals rest (no postures) for 2 minutes prior to exposure therapy.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Exposure therapy for social anxiety disorder
Primary Outcome Measure Information:
Title
LSAS-performance Subscale
Description
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.
Time Frame
Scores at 1 week post-treatment
Title
Subjective Units of Distress Scale (SUDs)
Description
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.
Time Frame
Scores at 1 week post-treatment
Title
Salivary Testosterone Levels
Description
Saliva sample taken before posture manipulation and 20 minutes after. Outcome is the change from pre- to post-manipulation in testosterone levels.
Time Frame
Baseline and 20 minutes after posture manipulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Hormones and Social Anxiety Disorder Treatment
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