Social Anxiety Disorder
Conditions
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy
Exposure therapy for social anxiety disorder
Sponsors
Jasper A. Smits
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LSAS-performance Subscale | 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. |
| Subjective Units of Distress Scale (SUDs) | 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. |
| Salivary Testosterone Levels | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Power Posing Individuals hold two, 1-minute postures associated with dominance and high power prior to exposure therapy.
Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder | 26 |
| Submissive Posing Individuals hold two, 1-minute postures associated with submissiveness and low power prior to exposure therapy.
Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder | 27 |
| Rest Individuals rest (no postures) for 2 minutes prior to exposure therapy.
Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder | 20 |
| Total | 73 |
Baseline characteristics
| Characteristic | Power Posing | Submissive Posing | Rest | Total |
|---|---|---|---|---|
| Age, Continuous | 26.88 years STANDARD_DEVIATION 6.99 | 25.26 years STANDARD_DEVIATION 8.99 | 24.60 years STANDARD_DEVIATION 5.83 | 25.66 years STANDARD_DEVIATION 7.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 9 Participants | 3 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 17 Participants | 16 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| LSAS-performance | 37.96 units on a scale STANDARD_DEVIATION 14.39 | 36.19 units on a scale STANDARD_DEVIATION 10.92 | 37.85 units on a scale STANDARD_DEVIATION 10.16 | 37.27 units on a scale STANDARD_DEVIATION 11.96 |
| Peak SUDS during exposure | 76.31 units on a scale STANDARD_DEVIATION 14.86 | 77.74 units on a scale STANDARD_DEVIATION 15.03 | 77.50 units on a scale STANDARD_DEVIATION 11.2 | 77.16 units on a scale STANDARD_DEVIATION 13.85 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 5 Participants | 3 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 3 Participants | 13 Participants |
| Race (NIH/OMB) White | 14 Participants | 14 Participants | 11 Participants | 39 Participants |
| Region of Enrollment United States | 26 Participants | 27 Participants | 20 Participants | 73 Participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 16 Participants | 52 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 4 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| other Total, other adverse events | 0 / 26 | 0 / 27 | 0 / 20 |
| serious Total, serious adverse events | 0 / 26 | 0 / 27 | 0 / 20 |
Outcome results
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.
Time frame: Scores at 1 week post-treatment
Population: 4 individuals did not complete LSAS at post-treatment; accordingly the analyses were conducted with only 69 individuals (versus the total sample size of 73) who had complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Power Posing | LSAS-performance Subscale | 34.04 units on a scale | Standard Deviation 14.76 |
| Submissive Posing | LSAS-performance Subscale | 32.54 units on a scale | Standard Deviation 8.74 |
| Rest | LSAS-performance Subscale | 32.05 units on a scale | Standard Deviation 13.7 |
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.
Time frame: Baseline and 20 minutes after posture manipulation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Power Posing | Salivary Testosterone Levels | -2.31 pg/mL | Standard Deviation 10.82 |
| Submissive Posing | Salivary Testosterone Levels | -0.88 pg/mL | Standard Deviation 33.31 |
| Rest | Salivary Testosterone Levels | -1.47 pg/mL | Standard Deviation 54.56 |
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.
Time frame: Scores at 1 week post-treatment
Population: 8 individuals did not complete the post-treatment exposure; accordingly the analyses were conducted with only 66 individuals (versus the total sample size of 73) who had complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Power Posing | Subjective Units of Distress Scale (SUDs) | 59.26 units on a scale | Standard Deviation 14.43 |
| Submissive Posing | Subjective Units of Distress Scale (SUDs) | 59.17 units on a scale | Standard Deviation 23.85 |
| Rest | Subjective Units of Distress Scale (SUDs) | 48.75 units on a scale | Standard Deviation 19.79 |