Brief Intervention to Reduce Fear of Public Speaking

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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

Locations

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

• Study Director: Franklin Schneier, MD; NYSPI

  Study Documents (Full-Text)

Documents provided by Franklin Schneier, New York State Psychiatric Institute:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] July 9, 2018

More Information

• 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
• 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:

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