Back to resultsBrief Intervention to Reduce Fear of Public Speaking
Primary Purpose
Social Anxiety Disorder
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
propranolol
Placebo
Sponsored by
About this trial
This is an interventional other trial for Social Anxiety Disorder focused on measuring propranolol, public speaking anxiety
Eligibility Criteria
Inclusion Criteria:
- 18-60 years of age at the time of consent
- Principal Diagnosis of Social Anxiety Disorder, Performance only type
- Has clinically significant fear of public speaking
- Physically healthy
- If female, non-pregnant and not nursing
- Off all psychotropic drug for at least 4 weeks
- A level of understanding sufficient to provide written informed consent to all required study tests and procedures.
Exclusion Criteria:
- History of other serious psychiatric disorder
- Current Major Depressive Disorder
- Presence of developmental disorder or intellectual disability
- SAD patients with SAD not of the performance only type
- Women who are pregnant or nursing
- Current use of psychiatric medication
- Current substance use disorder
- Persons planning to start another treatment during the study period.
- Any significant medical condition that might increase the risk or participation (e.g., seizure disorder, respiratory disorders [e.g., bronchial asthma], cardiovascular disease [e.g., congestive heart failure, heart arrhythmias, sinus bradycardia and greater than first degree block ], low blood pressure [ < 90/60], diabetes, liver or kidney disorders)
- Use of medications that might negatively interact with propranolol (e.g., ACE inhibitors; catecholamine depleting drugs, such as reserpine; calcium channel blockers; digitalis glycosides; haloperidol; chlorpromazine; aluminum hydroxide gel; phenytoin; phenobarbitone; rifampin; antipyrine; lidocaine; cimetidine; theophylline)
Sites / Locations
- New York State Psychiatric Institute, 1051 Riverside Drive
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Propranolol
placebo capsule
Arm Description
Propranolol 40 mg capsule, given once after fear activation procedure
Placebo capsule, given once after fear activation procedure
Outcomes
Primary Outcome Measures
Personal Report of Confidence as a Speaker
total score on this self report measure of fear of public speaking. Scored from 0-30, with higher scores indicating better outcome
Secondary Outcome Measures
Behavioral Avoidance Task
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
Full Information
NCT ID
NCT02790736
First Posted
May 26, 2016
Last Updated
May 11, 2023
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT02790736
Brief Title
Brief Intervention to Reduce Fear of Public Speaking
Official Title
Brief Intervention to Reduce Fear of Public Speaking
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 restrictions
Study Start Date
June 2016 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will test the efficacy of propranolol or placebo, administered after retrieval of a previously acquired public speaking fear, in reducing fear and avoidance of public speaking.
Detailed Description
Twenty subjects with Performance-Only type of Social Anxiety Disorder will be enrolled in the study. Participants will complete baseline assessments of fear and avoidance of public speaking. Participants will be randomly assigned to a single dose of propranolol 40mg or placebo, administered immediately after a fear activation procedure. Primary outcome assessment will be self-reported fear of public speaking and avoidance behavior in a behavioral avoidance task 2 weeks after the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
propranolol, public speaking anxiety
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propranolol
Arm Type
Experimental
Arm Description
Propranolol 40 mg capsule, given once after fear activation procedure
Arm Title
placebo capsule
Arm Type
Placebo Comparator
Arm Description
Placebo capsule, given once after fear activation procedure
Intervention Type
Drug
Intervention Name(s)
propranolol
Other Intervention Name(s)
Innopran XL
Intervention Description
active treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Oral Tablet
Intervention Description
inactive pill
Primary Outcome Measure Information:
Title
Personal Report of Confidence as a Speaker
Description
total score on this self report measure of fear of public speaking. Scored from 0-30, with higher scores indicating better outcome
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Behavioral Avoidance Task
Description
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
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-60 years of age at the time of consent
Principal Diagnosis of Social Anxiety Disorder, Performance only type
Has clinically significant fear of public speaking
Physically healthy
If female, non-pregnant and not nursing
Off all psychotropic drug for at least 4 weeks
A level of understanding sufficient to provide written informed consent to all required study tests and procedures.
Exclusion Criteria:
History of other serious psychiatric disorder
Current Major Depressive Disorder
Presence of developmental disorder or intellectual disability
SAD patients with SAD not of the performance only type
Women who are pregnant or nursing
Current use of psychiatric medication
Current substance use disorder
Persons planning to start another treatment during the study period.
Any significant medical condition that might increase the risk or participation (e.g., seizure disorder, respiratory disorders [e.g., bronchial asthma], cardiovascular disease [e.g., congestive heart failure, heart arrhythmias, sinus bradycardia and greater than first degree block ], low blood pressure [ < 90/60], diabetes, liver or kidney disorders)
Use of medications that might negatively interact with propranolol (e.g., ACE inhibitors; catecholamine depleting drugs, such as reserpine; calcium channel blockers; digitalis glycosides; haloperidol; chlorpromazine; aluminum hydroxide gel; phenytoin; phenobarbitone; rifampin; antipyrine; lidocaine; cimetidine; theophylline)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franklin Schneier, MD
Organizational Affiliation
NYSPI
Official's Role
Study Director
Facility Information:
Facility Name
New York State Psychiatric Institute, 1051 Riverside Drive
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brief Intervention to Reduce Fear of Public Speaking
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