跳至主要内容
临床试验/NCT02622087
NCT02622087已完成不适用

Sex Hormones and Fear Inhibition: a Novel Exploration of Why Women Are so Vulnerable to Anxiety Disorders

The University of New South Wales2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Change from baseline in level of approach on the Behavioural Approach Test (BAT)

研究概览

简要总结

The purpose of this study is to determine whether levels of sex hormones (including estrogen and progesterone) influence women's response to treatment for Specific Phobia of spiders. It is hypothesised that women will show less relapse of symptoms of spider phobia if they receive treatment during a period of high levels of sex hormones.

详细描述

Detailed description of the Behavioural Avoidance Test (BAT):

Participants will be asked to stand in front of a closed door. They will be asked by the experimenter to approach the spider as closely as possibly, but they are reminded they can stop at anytime. Participants will then enter a room in which a table will be located approximately 3 meters in front of them. On top of the table will be a glass terrarium containing a fast moving spider (Huntsman - Holconis). These spiders were chosen because they are all low risk (non toxic) and non-aggressive to humans. In addition, these spiders are also commonly found in homes or gardens, thus increasing the ecological validity of our study. Participants will be asked to approach the spider in a stepwise manner (i.e., in 10 steps). Performance will be scored on a 10-point scale that corresponds with the steps taken during the test; the steps are 0 = refuses to enter room, 1 = stops 3m from terrarium, 2 = stops 2m, 3 = stops 1m, 4 = stops close to terrarium, 5 = touches terrarium, 6 = removes lid, 7 = puts hand in terrarium, 8 = touches inside walls and floor of terrarium, 9 = guides spider over hand which is resting on the floor of the terrarium. For steps 7 to 9 the experimenter will relocate the spider to a larger enclosure with a zippered opening that can be arranged so the spider cannot escape the enclosure and the participant will be provided with a long sleeved shirt and a gardening glove. Once the participant has entered the room, the experimenter does not persuade the participant to continue.

Detailed Description of One-Session-Treatment (OST):

There will be three sessions. Session 1 involves the preparation stage, a pre-treatment interview, pre-treatment measures, and OST. During the pre-treatment interview a clinical psychologist will collect information about the participants fear of spiders and provide a rationale for treatment. The participant will then complete pre-treatment measures, including the BAT (to assess pre-treatment levels of avoidance; see detailed protocol above), as well as self-report questionnaires. After completing the pre-treatment measures, participants will then begin OST. This treatment will strictly follow Öst's manual for specific phobias. It will take a maximum of three hours and has been shown to be highly effective in treating specific phobia, including spider phobia. OST involves the use of a maximum of 4 spiders of varying sizes, from 0.5cm to 5cm, housed in glass terrariums. Two spider species will be used: St Andrew's Cross (Argiope) and Huntsman (Holconia immanis). These spiders were chosen because they are all low risk (non toxic) and non-aggressive to humans. In addition, these spiders are also commonly found in homes or gardens, thus increasing the ecological validity of our treatment. There are a total of five steps and at the start of each step, the experimenter will provide instructions and then model the behaviour for the participant. Each step will be repeated until the participant experiences a reduction of at least 50% in their anxiety, as assessed by Subjective Units of Distress ratings (SUDS; 0-100), or rate the conviction in their belief that a catastrophe will occur as 0 (0-100). Steps 1-4 will be completed with the St Andrew's Cross spiders. Step 1 involves teaching the participant how to catch the smallest spider with a glass and postcard (i.e., placing glass upside down over the spider in the terrarium and to slide the postcard underneath). Step 2 involves touching the spider from behind with the dominant index finger. Step 3 involves letting the spider walk on the participant's hands. Step 4 involves allowing the spider to walk on the participant's legs and body. Steps 1-4 are then repeated with larger St Andrew's cross spiders. After completing this, the participant will be encouraged to have the two largest St Andrew's cross spiders walk on their hands simultaneously. Step 5 is provided in the treatment as an extra step and will be completed only if there is time remaining and if the participant gives consent. Step 5 involves encouraging the participant to complete the final step of the BAT using the Huntsman spider (i.e., guiding the spider over their gloved hand). The experiment ends when all steps are completed, or if the maximum 3 hour time limit has been reached, or if the participant indicates that they do not want to continue. After treatment, participants will be checked to ensure they are not feeling any distress and will be accompanied by the experimenter to Healthscope Pathology to provide a blood sample to verify hormone levels.

Session 2, a follow-up session, will occur one-week later, as per Öst's treatment manual. During this session, post-treatment measures will be taken, including structured clinical interview assessment, self-report questionnaires and BAT.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-35 with Specific Phobia of Spiders
  • Both women who are naturally cycling and women using hormonal contraceptives are eligible to participate

排除标准

  • Certain kinds of comorbid mental illness, including psychosis, bipolar disorder, substance abuse
  • Participants with neurological or endocrinological disorders
  • In women who are naturally cycling, those who do not have a regular menstrual cycle, are pregnant, or breastfeeding

研究组 & 干预措施

Hormonal contraceptive

Experimental

Women who receive one-session-treatment while they are on the hormonal contraceptive pill

干预措施: One-Session-Treatment (Behavioral)

Naturally cycling- high estradiol

Experimental

Naturally cycling women who receive one-session-treatment during a period of high estradiol

干预措施: One-Session-Treatment (Behavioral)

Naturally cycling-low estradiol

Experimental

Naturally cycling women who receive one-session-treatment during a period of low estradiol

干预措施: One-Session-Treatment (Behavioral)

结局指标

主要结局

Change from baseline in level of approach on the Behavioural Approach Test (BAT)

时间窗: Pre- treatment, and 1 week and 12 weeks post treatment

次要结局

  • Change from baseline in severity of spider phobia on the Spider Phobia Questionnaire(Pre-treatment, and 1 week and 12 weeks post treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bronwyn Margaret Graham

Lecturer and Discovery Early Career Fellow

The University of New South Wales

研究点 (2)

Loading locations...

相似试验