The Impact of Stress on Exposure-based Treatment Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in the Behavioral Approach Test (BAT) with spiders (treated fear stimulus)
研究概览
简要总结
This study investigates whether stress can augment exposure therapy outcome in patients with specific phobia (spider phobia).
详细描述
Stress has been shown to modulate fear extinction. The present study is aimed at investigating whether stress (administered prior to exposure with the socially evaluated cold pressor test) augments exposure therapy outcome in patients with specific phobia (spider phobia). Furthermore, the effects of stress on the generalization of exposure-induced symptom reduction towards untreated fear stimuli (i.e. cockroaches) will be explored.
Participants are randomly assigned to the cold or warm water condition of the socially evaluated cold pressor test (SECPT; Schwabe et al., 2008). Thereafter, participants of both conditions receive 45 minutes of in-vivo exposure to spiders. The effects of stress on exposure-based anxiety reductions toward spiders (treated fear stimulus) and cockroaches (untreated fear stimulus to assess generalization of treatment outcome) are assessed on the behavioral, subjective and physiological level at pretreatment, posttreatment (24 hours after exposure) and follow-up (4 weeks after exposure).
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women using oral contraceptives (OC)
- •Specific phobia (spider phobia)
排除标准
- •Body Mass Index (BMI) < 19 or > 27
- •Pregnancy
- •Any acute or chronic mental, somatic, endocrine, or metabolic disease
- •Psychological, psychiatric, neurological or pharmacological treatment
- •Shift work
- •Smoking more than 5 cigarettes per month
- •Vaccination in the past 2 month
- •Drug or alcohol abuse
研究组 & 干预措施
Stress + Exposure
Stress Condition: Cold water condition of the socially evaluated cold pressor test (SECPT; Schwabe et al, 2008).
干预措施: Cold water condition (Other)
Control + Exposure
Control condition: Warm water condition of the SECPT.
干预措施: Warm water condition (Other)
结局指标
主要结局
Change in the Behavioral Approach Test (BAT) with spiders (treated fear stimulus)
时间窗: Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up)
During the Behavioral Approach Test (BAT) the closest distance to a spider as well as subjective fear and heart rate is measured.
Change in the Behavioral Approach Test with Cockroaches (untreated fear stimulus)
时间窗: Pretreatment, Follow-up (with approx. 4 weeks between pretreatment and follow-up)
During the Behavioral Approach Test (BAT) the closest distance to a cockroach as well as subjective fear and heart rate is measured.
次要结局
- Change in the Spider-fear Related questionnaires(Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up))
- Blood pressure(9 times at Pretreatment)
- Change in the Cockroach-fear related questionnaires(Pretreatment, Posttreatment, Follow-up (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up))
- Free cortisol concentrations(5 times at Pretreatment, 2 times at Posttreatment, 2 times at Follow-up. (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up))
- Activity of the enzyme alpha amylase(5 times at Pretreatment, 2 times at Posttreatment, 2 times at Follow-up ( (with approx. 1 day between pre- and posttreatment and 4 weeks between pretreatment and follow-up))
研究者
Armin Zlomuzica
Dr. / Principal Investigator
Ruhr University of Bochum