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NCT02924610 Clinical Trial

Brief Intervention to Reduce Fear

Social Anxiety Disorder Clinical Trial

Official title:
Brief Intervention to Reduce Fear

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02924610
Other study ID # 7293
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received October 3, 2016
Last updated October 4, 2016
Start date October 2016

Study information
Verified date October 2016
Source Research Foundation for Mental Hygiene, Inc.
Contact Danielle Moskow, BA
Phone 6467748013
Email dmoskow@nyspi.columbia.edu
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Description:

Twenty subjects with Performance-Only type of Social Anxiety Disorder will be enrolled in the study. They will complete baseline assessments of fear and avoidance of public speaking. They 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: Principal Diagnosis of Social Anxiety Disorder, Performance only type; has clinically significant fear of public speaking; physically healthy

Exclusion Criteria: History of other serious psychiatric disorder, current Major Depressive Disorder, women who are pregnant or nursing, current use of psychiatric medication, persons planning to start another treatment during the study period, any significant medical condition that might increase the risk or participation or use of medications that might negatively interact with propranolol.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Drug:
• propranolol
active treatment
• placebo
inactive pill

Locations
Country Name City State
United States New York State Psychiatric Institute, 1051 Riverside Drive New York New York

Sponsors (1)
Lead Sponsor Collaborator
Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Personal Report of Confidence as a Speaker self report measure of fear of public speaking 2 weeks No
Secondary Behavioral Avoidance Task task assessing fear and avoidance of public speaking 2 weeks No
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