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

NCT02622087 | Completed

• 1 other identifier: MQ13002
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Phobia, Specific

Outcome Measures

Primary Outcomes (1)

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

  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

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

Study Arms (3)

Hormonal contraceptive

EXPERIMENTAL

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

Behavioral: One-Session-Treatment

Naturally cycling- high estradiol

EXPERIMENTAL

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

Behavioral: One-Session-Treatment

Naturally cycling-low estradiol

EXPERIMENTAL

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

Behavioral: One-Session-Treatment

Interventions

One-Session-Treatment BEHAVIORAL

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.

Hormonal contraceptive; Naturally cycling- high estradiol; Naturally cycling-low estradiol

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of New South Wales: lead

Study Sites (1)

University of New South Wales

Sydney, New South Wales, 2052, Australia

Location

MeSH Terms

Conditions

Phobia, Specific

Study Officials

• Bronwyn M Graham, PhD

  University of New South Wales Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer and Discovery Early Career Fellow

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: December 4, 2015
• Study Start: November 1, 2015
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: September 21, 2017

Record last verified: 2017-09

Locations

AU (1)