Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02622087




Registration number
NCT02622087
Ethics application status
Date submitted
30/06/2015
Date registered
4/12/2015
Date last updated
21/09/2017

Titles & IDs
Public title
The Impact of Sex Hormones on One-session Treatment for Spider Phobia in Women
Scientific title
Sex Hormones and Fear Inhibition: a Novel Exploration of Why Women Are so Vulnerable to Anxiety Disorders
Secondary ID [1] 0 0
MQ13002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Phobia, Specific 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - One-Session-Treatment

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

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

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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in level of approach on the Behavioural Approach Test (BAT)
Timepoint [1] 0 0
Pre- treatment, and 1 week and 12 weeks post treatment
Secondary outcome [1] 0 0
Change from baseline in severity of spider phobia on the Spider Phobia Questionnaire
Timepoint [1] 0 0
Pre-treatment, and 1 week and 12 weeks post treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2017
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
2052 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02622087
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bronwyn M Graham, PhD
Address 0 0
University of New South Wales Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02622087