Trial Outcomes & Findings for Hormones and Social Anxiety Disorder Treatment (NCT NCT02482805)

Last Updated: 2017-11-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

73 participants

Primary outcome timeframe

Scores at 1 week post-treatment

Results posted on

2017-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	Rest Individuals rest (no postures) for 2 minutes prior to exposure therapy. Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder
Overall Study STARTED	26	27	20
Overall Study COMPLETED	22	23	20
Overall Study NOT COMPLETED	4	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	Rest Individuals rest (no postures) for 2 minutes prior to exposure therapy. Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder
Overall Study Lost to Follow-up	4	4	0

Baseline Characteristics

Hormones and Social Anxiety Disorder Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Power Posing n=26 Participants 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	Submissive Posing n=27 Participants 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	Rest n=20 Participants Individuals rest (no postures) for 2 minutes prior to exposure therapy. Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder	Total n=73 Participants Total of all reporting groups
Age, Continuous	26.88 years STANDARD_DEVIATION 6.99 • n=5 Participants	25.26 years STANDARD_DEVIATION 8.99 • n=7 Participants	24.60 years STANDARD_DEVIATION 5.83 • n=5 Participants	25.66 years STANDARD_DEVIATION 7.48 • n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	16 Participants n=5 Participants	52 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	21 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	9 Participants n=7 Participants	3 Participants n=5 Participants	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	17 Participants n=7 Participants	16 Participants n=5 Participants	53 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	39 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment United States	26 Participants n=5 Participants	27 Participants n=7 Participants	20 Participants n=5 Participants	73 Participants n=4 Participants
LSAS-performance	37.96 units on a scale STANDARD_DEVIATION 14.39 • n=5 Participants	36.19 units on a scale STANDARD_DEVIATION 10.92 • n=7 Participants	37.85 units on a scale STANDARD_DEVIATION 10.16 • n=5 Participants	37.27 units on a scale STANDARD_DEVIATION 11.96 • n=4 Participants
Peak SUDS during exposure	76.31 units on a scale STANDARD_DEVIATION 14.86 • n=5 Participants	77.74 units on a scale STANDARD_DEVIATION 15.03 • n=7 Participants	77.50 units on a scale STANDARD_DEVIATION 11.20 • n=5 Participants	77.16 units on a scale STANDARD_DEVIATION 13.85 • n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Power Posing n=23 Participants 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	Submissive Posing n=26 Participants 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	Rest n=20 Participants Individuals rest (no postures) for 2 minutes prior to exposure therapy. Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder
LSAS-performance Subscale	34.04 units on a scale Standard Deviation 14.76	32.54 units on a scale Standard Deviation 8.74	32.05 units on a scale Standard Deviation 13.70

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Power Posing n=23 Participants 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	Submissive Posing n=23 Participants 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	Rest n=20 Participants Individuals rest (no postures) for 2 minutes prior to exposure therapy. Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder
Subjective Units of Distress Scale (SUDs)	59.26 units on a scale Standard Deviation 14.43	59.17 units on a scale Standard Deviation 23.85	48.75 units on a scale Standard Deviation 19.79

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Power Posing n=26 Participants 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	Submissive Posing n=27 Participants 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	Rest n=20 Participants Individuals rest (no postures) for 2 minutes prior to exposure therapy. Cognitive Behavioral Therapy: Exposure therapy for social anxiety disorder
Salivary Testosterone Levels	-2.31 pg/mL Standard Deviation 10.82	-0.88 pg/mL Standard Deviation 33.31	-1.47 pg/mL Standard Deviation 54.56

Adverse Events

Power Posing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Submissive Posing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rest

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michelle Davis

University of Texas at Austin

Phone: 214-470-1371

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place