Noradrenergic Manipulation and Virtual Reality Exposure Therapy in Phobic Participants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- FAS (Flight Anxiety Situations Questionnaire)
研究概览
简要总结
Recent advances in animal research have identified pharmacological agents that appear to both accelerate and consolidate extinction learning. One cognitive enhancers is Yohimbine hydrochloride (YOH). A finding in animal literature is that the administration of YOH during extinction trials accelerates fear reduction and may convert ineffective exposures in to successful ones. It is thought that the mechanism of enhanced emotional memory is through elevated norepinephrine. However, recent findings demonstrate mixed results. In a randomized controlled trial claustrophobic participants underwent exposure in combination with YOH or placebo. The YOH group showed significantly better results on anxiety improvement than the placebo group. In a more recent study with participants with fear of flying no additional benefits of YOH were demonstrated. Therefore, we intend to replicate and extend these studies by enhancing the dose of YOH in combination with VRET and by extending our experimental design with another group which receives propranolol in combination with VRET. Propranolol is β-adrenergic receptor antagonist, which has proven to disrupt reconsolidation in healthy humans. In this randomized controlled trial a between groups design is chosen to further characterize the differential within and between trial extinction and to enhance possible between groups effects. Sixty participants with fear of flying or fear of heights will be randomly assigned to one of the following three conditions 1) VRET plus YOH, 2) VRET plus Propranolol, or 3) VRET plus placebo. Participants in all conditions will be offered three sessions of VRET over a period of two weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Marked fear of flying or acrophobia, indicated by a subjective fear rating of moderate or higher on anxiety specific measures.
- •Being older than 18 years and younger than 75 years.
排除标准
- 未提供
研究组 & 干预措施
VRET plus placebo
Virtual Reality Exposure Therapy combined with the administration of a non-active placebo pill
干预措施: Virtual Reality Exposure Therapy (VRET) (Behavioral)
VRET plus propranolol
Virtual Reality Exposure Therapy combined with the administration of propranolol
干预措施: Virtual Reality Exposure Therapy (VRET) (Behavioral)
VRET plus Yohimbine
Virtual Reality Exposure Therapy combined with the administration of yohimbine.
干预措施: Virtual Reality Exposure Therapy (VRET) (Behavioral)
结局指标
主要结局
FAS (Flight Anxiety Situations Questionnaire)
时间窗: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
The FAS is 32-item, self-report inventory designed to measure anxiety related to flying experienced in different situations. The FAS is divided into three subscales: the Anticipation scale, which represents situations before the actual flight, the In-flight scale, which refers to situations during a flight and the Generalized flight scale.
AQ (Acrophobia Questionnaire)
时间窗: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
The AQ (Cohen, 1977) is a 40-item self-report measure to assess anxiety in height situations. The AQ measures anxiety and avoidance behavior relative to height situations. Subject can express their fear on a scale ranging from 0-6, whereby 0 stands for "no fear at all" and 6 for "almost panic" (ranging from 0-120).
WAQ (Weekly Anxiety Questionnaire)
时间窗: In session 1, 2 and 3 and Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
The WAQ is an author-constructed transdiagnostic anxiety questionnaire to rate severity of experienced general anxiety. The WAQ is a 10-item self-report measure on which participants can rate their experienced anxieties. Ratings can be scored on a five-point Likert scale ranging from "not at all" to "permanently".
次要结局
- FAM (Flight Anxiety Modalities Questionnaire)(Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment))
- ATHQ (Attitude towards heights questionnaire)(Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment))
- DASS (Depression Anxiety Stress Scale)(Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment))
- PIT (Prospective Imagery Task)(Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment))
- ASI (Anxiety Sensitivity Inventory)(Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment))
- SUDs (Subjective Units of Discomfort)(Every 3 minutes during exposure (exposure will be done twicely 25 minutes every therapy session. Thus, starting at minute 1 every 3 minute a SUD will be asked. After a break of 10 minutes, exposure will start again (25 minutes).)
研究者
Paul M.G.Emmelkamp
Prof. dr.
VU University of Amsterdam