Brief Intervention to Reduce Fear of Public Speaking

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.

Study Overview

• Status: Terminated
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Drug: propranolol; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute, 1051 Riverside Drive

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propranolol; Propranolol 40 mg capsule, given once after fear activation procedure	Drug: propranolol; active treatment; Other Names: Innopran XL
Placebo Comparator: placebo capsule; Placebo capsule, given once after fear activation procedure	Drug: Placebo; inactive pill; Other Names: Placebo Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 weeks

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Investigators: Study Director: Franklin Schneier, MD, NYSPI

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: June 3, 2016
• First Posted (Estimated): June 6, 2016

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: propranolol; public speaking anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: 7293 (SAD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO