NL-OMON49420尚未招募2 期
Transcutaneous vagus nerve stimulation to enhance exposure efficacy in public speaking anxiety - tvNS and exposure for public speaking anxiety
niversiteit Leiden0 个研究点目标入组 52 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •A. Between 18-70 years old
- •B. Social Anxiety Disorder (SAD) as established with a structured interview
- •(MINI), and with speech anxiety as primary fear
- •C. Self reported SAD symptoms above clinical cut-off (score > 30 on the LSAS).
排除标准
- •A. Prior non response to exposure therapy (i.c. speech exposure) for SAD
- •symptoms, as defined by the patient*s report of receiving specific and regular
- •exposure assignments as part of previous therapy.
- •B. Prior participation in tVNS research
- •C. Entry of patients with other mood or anxiety disorders will be permitted in
- •order to increase accrual of a clinically relevant sample; however in cases
- •where SAD is not judged to be the predominant disorder, participants will not
- •be eligible.
- •D. Psychosis or delusion disorders (current or in the past)
- •E. Patients with significant suicidal ideations or who have enacted suicidal
- •behaviors within 6 months prior to intake will be excluded from participation
- •and referred for appropriate clinical intervention.
- •F. Mental retardation
- •G. (History of) Substance or alcohol dependence
- •H. Somatic illness
- •I. Pregnancy or lactation
- •J. Antipsychotic medication
- •K. Participants that use antidepressants or benzodiazepines will not be
- •excluded, but have to be on a stable dose for at least 6 weeks prior to
- •enrollment.
- •L. Insufficient ability to speak and write Dutch
研究者
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