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.
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
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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.
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.
- Conditions
- Phobia, Specific
- 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 group | Role | What they receive |
|---|---|---|
| Hormonal contraceptive | Experimental | Women who receive one-session-treatment while they are on the hormonal contraceptive pill Receives: Behavioral: One-Session-Treatment |
| Naturally cycling- high estradiol | Experimental | Naturally cycling women who receive one-session-treatment during a period of high estradiol Receives: Behavioral: One-Session-Treatment |
| Naturally cycling-low estradiol | Experimental | Naturally 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.
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)
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.
- First posted4 Dec 2015 (estimated)
- Study startNov 2015
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobia, SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bronwyn Margaret Graham, The University of New South Wales
- Investigators
- Bronwyn M Graham, PhD, Principal investigator, University of New South Wales Australia
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Hormones and Fear Inhibition: a Novel Exploration of Why Women Are so Vulnerable to Anxiety Disorders
- ClinicalTrials.gov ID
- NCT02622087
- Acronym / sponsor ID
- MQ13002
- Conditions
- Phobia, Specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 4 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hormonal contraceptive | Experimental | Behavioral: One-Session-TreatmentWomen who receive one-session-treatment while they are on the hormonal contraceptive pill |
| Naturally cycling- high estradiol | Experimental | Behavioral: One-Session-TreatmentNaturally cycling women who receive one-session-treatment during a period of high estradiol |
| Naturally cycling-low estradiol | Experimental | Behavioral: One-Session-TreatmentNaturally cycling women who receive one-session-treatment during a period of low estradiol |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged 18-35 with Specific Phobia of Spiders
- Both women who are naturally cycling and women using hormonal contraceptives are eligible to participate
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-Session-TreatmentThere 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. | Behavioural | Hormonal contraceptive, Naturally cycling- high estradiol, Naturally cycling-low estradiol |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bronwyn M Graham, PhD principal investigator
University of New South Wales Australia
1 site in 1 country: see every site and its status.
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.