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Brief Intervention to Reduce Fear of Public Speaking

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ClinicalTrials.gov Identifier: NCT02790736
Recruitment Status : Terminated (COVID-19 restrictions)
First Posted : June 6, 2016
Results First Posted : September 5, 2018
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Franklin Schneier, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: propranolol Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Brief Intervention to Reduce Fear of Public Speaking
Actual Study Start Date : June 2016
Actual Primary Completion Date : October 30, 2020
Actual Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Propranolol
Propranolol 40 mg capsule, given once after fear activation procedure
Drug: propranolol
active treatment
Other Name: Innopran XL

Placebo Comparator: placebo capsule
Placebo capsule, given once after fear activation procedure
Drug: Placebo
inactive pill
Other Name: Placebo Oral Tablet




Primary Outcome Measures :
  1. Personal Report of Confidence as a Speaker [ Time Frame: 2 weeks ]
    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 :
  1. Behavioral Avoidance Task [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT02790736


Locations
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United States, New York
New York State Psychiatric Institute, 1051 Riverside Drive
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Study Director: Franklin Schneier, MD NYSPI
  Study Documents (Full-Text)

Documents provided by Franklin Schneier, New York State Psychiatric Institute:
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Responsible Party: Franklin Schneier, Research Psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02790736    
Obsolete Identifiers: NCT02924610
Other Study ID Numbers: 7293 (SAD)
First Posted: June 6, 2016    Key Record Dates
Results First Posted: September 5, 2018
Last Update Posted: October 6, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Franklin Schneier, New York State Psychiatric Institute:
propranolol
public speaking anxiety
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents