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Trial record 1 of 1 for:    NCT02622087
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The Impact of Sex Hormones on One-session Treatment for Spider Phobia in Women

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ClinicalTrials.gov Identifier: NCT02622087
Recruitment Status : Completed
First Posted : December 4, 2015
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Bronwyn Margaret Graham, The University of New South Wales

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Phobia, Specific Behavioral: One-Session-Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sex Hormones and Fear Inhibition: a Novel Exploration of Why Women Are so Vulnerable to Anxiety Disorders
Study Start Date : November 2015
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : June 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hormonal contraceptive
Women who receive one-session-treatment while they are on the hormonal contraceptive pill
Behavioral: One-Session-Treatment
There are a total of five steps, each to be repeated until the participant experiences a reduction of at least 50% in their anxiety. Step 1 is catching a spider with a glass and postcard. Step 2 is touching a spider from behind with the dominant index finger. Step 3 is letting a spider walk on the participant's hands. Step 4 is allowing a spider to walk on the participant's legs and body. Steps 1-4 are repeated with larger spiders, and then the two biggest spiders will walk on the participants' hands simultaneously. Step 5 is using a chopstick to guide a huntsman spider over their gloved hand. Treatment 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.

Experimental: Naturally cycling- high estradiol
Naturally cycling women who receive one-session-treatment during a period of high estradiol
Behavioral: One-Session-Treatment
There are a total of five steps, each to be repeated until the participant experiences a reduction of at least 50% in their anxiety. Step 1 is catching a spider with a glass and postcard. Step 2 is touching a spider from behind with the dominant index finger. Step 3 is letting a spider walk on the participant's hands. Step 4 is allowing a spider to walk on the participant's legs and body. Steps 1-4 are repeated with larger spiders, and then the two biggest spiders will walk on the participants' hands simultaneously. Step 5 is using a chopstick to guide a huntsman spider over their gloved hand. Treatment 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.

Experimental: Naturally cycling-low estradiol
Naturally cycling women who receive one-session-treatment during a period of low estradiol
Behavioral: One-Session-Treatment
There are a total of five steps, each to be repeated until the participant experiences a reduction of at least 50% in their anxiety. Step 1 is catching a spider with a glass and postcard. Step 2 is touching a spider from behind with the dominant index finger. Step 3 is letting a spider walk on the participant's hands. Step 4 is allowing a spider to walk on the participant's legs and body. Steps 1-4 are repeated with larger spiders, and then the two biggest spiders will walk on the participants' hands simultaneously. Step 5 is using a chopstick to guide a huntsman spider over their gloved hand. Treatment 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.




Primary Outcome Measures :
  1. Change from baseline in level of approach on the Behavioural Approach Test (BAT) [ Time Frame: Pre- treatment, and 1 week and 12 weeks post treatment ]

Secondary Outcome Measures :
  1. Change from baseline in severity of spider phobia on the Spider Phobia Questionnaire [ Time Frame: Pre-treatment, and 1 week and 12 weeks post treatment ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Male
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622087


Locations
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Australia, New South Wales
University of New South Wales
Sydney, New South Wales, Australia, 2052
Sponsors and Collaborators
The University of New South Wales
Investigators
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Principal Investigator: Bronwyn M Graham, PhD University of New South Wales Australia

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Responsible Party: Bronwyn Margaret Graham, Lecturer and Discovery Early Career Fellow, The University of New South Wales
ClinicalTrials.gov Identifier: NCT02622087    
Other Study ID Numbers: MQ13002
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Phobic Disorders
Anxiety Disorders
Mental Disorders
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Hormones
Estradiol
Polyestradiol phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female