Brief Intervention to Reduce Fear of Public Speaking

Phase 4

Terminated

• Conditions: Social Anxiety Disorder
• Interventions: Drug: propranolol; Drug: Placebo

• Registration Number: NCT02790736
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-05-26
• Study Start: 2016-06
• Study First Submitted QC: 2016-06-03
• Study First Posted: 2016-06-06
• Results First Submitted: 2018-07-12
• Results First Submitted QC: 2018-08-06
• Results First Posted: 2018-09-05
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propranolol	propranolol	Propranolol 40 mg capsule, given once after fear activation procedure
placebo capsule	Placebo	Placebo capsule, given once after fear activation procedure

Primary Outcome Measures

Name	Time	Method
Personal Report of Confidence as a Speaker	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

Name	Time	Method
Behavioral Avoidance Task	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

Trial Locations

Locations (1)

New York State Psychiatric Institute, 1051 Riverside Drive; 🇺🇸 New York, New York, United States