Brief Intervention to Reduce Fear of Public Speaking

Study Overview
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Brief Summary
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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
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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.

Official Title
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Brief Intervention to Reduce Fear of Public Speaking

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Drug: propranolol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propranolol, public speaking anxiety