Trial Outcomes & Findings for Brief Intervention to Reduce Fear of Public Speaking (NCT NCT02790736)

NCT ID: NCT02790736

Last Updated: 2023-06-07

Results Overview

total score on this self report measure of fear of public speaking. Scored from 0-30, with higher scores indicating better outcome

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 6 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2023-06-07

Participant Flow

Participant milestones

Measure	Propranolol Propranolol 40 mg capsule, given once after fear activation procedure propranolol: active treatment	Placebo Capsule Placebo capsule, given once after fear activation procedure Placebo: inactive pill
Overall Study STARTED	5	1
Overall Study COMPLETED	5	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brief Intervention to Reduce Fear of Public Speaking

Baseline characteristics by cohort

Measure	Propranolol n=5 Participants Propranolol 40 mg capsule, given once after fear activation procedure propranolol: active treatment	Placebo Capsule n=1 Participants Placebo capsule, given once after fear activation procedure Placebo: inactive pill	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	1 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: persons with fear of public speaking

total score on this self report measure of fear of public speaking. Scored from 0-30, with higher scores indicating better outcome

Outcome measures

Measure	Propranolol n=5 Participants Propranolol 40 mg capsule, given once after fear activation procedure propranolol: active treatment	Placebo Capsule n=1 Participants Placebo capsule, given once after fear activation procedure Placebo: inactive pill
Personal Report of Confidence as a Speaker	6.6 change score on a scale Interval 1.0 to 13.0	6 change score on a scale Interval 6.0 to 6.0

SECONDARY outcome

Timeframe: 2 weeks

Up to 5 sequential public speaking challenges, specifically designed for each step to be of increasing difficulty for the individual. Each step is considered completed if subject agrees to try speaking, and speaks for 1 minute. Score is total number of completed steps (0-5) on this 5-step task, with 5 being best

Outcome measures

Measure	Propranolol n=5 Participants Propranolol 40 mg capsule, given once after fear activation procedure propranolol: active treatment	Placebo Capsule n=1 Participants Placebo capsule, given once after fear activation procedure Placebo: inactive pill
Behavioral Avoidance Task	4.2 steps Interval 4.0 to 5.0	4 steps Interval 4.0 to 4.0

Adverse Events

Propranolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Capsule

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

Franklin Schneier MD

NY State Psychiatric Institute

Phone: 6467748041

Email: fschneier@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place