Clinical trial NCT02790736: Brief Intervention to Reduce Fear of Public Speaking
Official title: Brief Intervention to Reduce Fear of Public Speaking
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Social Anxiety Disorder
Keywords: propranolol
public speaking anxiety
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2016-06-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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)

Primary outcomes:
measure: Personal Report of Confidence as a Speaker
timeFrame: 2 weeks
Secondary outcomes:
measure: Behavioral Avoidance Task
timeFrame: 2 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute, 1051 Riverside Drive
state: New York
Study officials:
affiliation: NYSPI
name: Franklin Schneier, MD
role: STUDY_DIRECTOR
References: