Brief Intervention to Reduce Fear of Public Speaking
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Personal Report of Confidence as a Speaker
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Propranolol
Propranolol 40 mg capsule, given once after fear activation procedure
干预措施: propranolol (Drug)
placebo capsule
Placebo capsule, given once after fear activation procedure
干预措施: Placebo (Drug)
结局指标
主要结局
Personal Report of Confidence as a Speaker
时间窗: 2 weeks
total score on this self report measure of fear of public speaking. Scored from 0-30, with higher scores indicating better outcome
次要结局
- Behavioral Avoidance Task(2 weeks)
研究者
Franklin Schneier
Research Psychiatrist
New York State Psychiatric Institute