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Hormones and Social Anxiety Disorder Treatment

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ClinicalTrials.gov Identifier: NCT02482805
Recruitment Status : Completed
First Posted : June 26, 2015
Results First Posted : October 16, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin

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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Behavioral: Cognitive Behavioral Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Hormones on Response to Exposure Therapy for Social Anxiety Disorder
Study Start Date : July 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Hormones

Arm Intervention/treatment
Experimental: Power Posing
Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.
Behavioral: Cognitive Behavioral Therapy
Exposure therapy for social anxiety disorder

Experimental: Submissive Posing
Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.
Behavioral: Cognitive Behavioral Therapy
Exposure therapy for social anxiety disorder

Experimental: Rest
Individuals rest (no postures) for 2 minutes prior to exposure therapy.
Behavioral: Cognitive Behavioral Therapy
Exposure therapy for social anxiety disorder




Primary Outcome Measures :
  1. LSAS-performance Subscale [ Time Frame: Scores at 1 week post-treatment ]

    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.


  2. Subjective Units of Distress Scale (SUDs) [ Time Frame: Scores at 1 week post-treatment ]

    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.


  3. Salivary Testosterone Levels [ Time Frame: Baseline and 20 minutes after posture manipulation ]
    Saliva sample taken before posture manipulation and 20 minutes after. Outcome is the change from pre- to post-manipulation in testosterone levels.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482805


Locations
United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02482805     History of Changes
Other Study ID Numbers: SAD - Hormones
First Posted: June 26, 2015    Key Record Dates
Results First Posted: October 16, 2017
Last Update Posted: November 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs