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Phobia, SpecificNCT02622087

The Impact of Sex Hormones on One-session Treatment for Spider Phobia in Women

A study testing One-Session-Treatment in people with Phobia, Specific, run by The University of New South Wales at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Phobia, Specific
What is being tested?
One-Session-Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteAustralia
Study dates
Nov 2015to 15 Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site
  • University of New South Wales

    Sydney, New South Wales, 2052

Other trials in Australia

About this study

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

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.

Read the detailed description

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.

Session 3 will occur 3 months later and will be a long-term follow-up session. Participants will undergo the same measures as in session 2. Participants will be fully debriefed regarding the aims and implications of the experiment. During this process, participants will be asked if they have any questions or concerns, and will be checked to ensure they are not feeling any distress.

Being tested
One-Session-Treatment
Medical subject headings
Phobia, Specific

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • One-Session-TreatmentBehavioural

    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.

Study groups in NCT02622087
Study groupRoleWhat they receive
Hormonal contraceptiveExperimentalWomen who receive one-session-treatment while they are on the hormonal contraceptive pill
Receives: Behavioral: One-Session-Treatment
Naturally cycling- high estradiolExperimentalNaturally cycling women who receive one-session-treatment during a period of high estradiol
Receives: Behavioral: One-Session-Treatment
Naturally cycling-low estradiolExperimentalNaturally cycling women who receive one-session-treatment during a period of low estradiol
Receives: Behavioral: One-Session-Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Pre- treatment, and 1 week and 12 weeks post treatment

Secondary outcomes (1)
  1. Change from baseline in severity of spider phobia on the Spider Phobia Questionnaire

    Measured: Pre-treatment, and 1 week and 12 weeks post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2015 (estimated)
  2. Study startNov 2015
  3. Primary completion15 Jun 2017
  4. Study completion15 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02622087
Sponsor's protocol ID
MQ13002
Status last verified
Sep 2017
First submitted
30 Jun 2015
Last updated
21 Sep 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing One-Session-Treatment in people with Phobia, Specific, run by The University of New South Wales at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017.

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