Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001525471
Ethics application status
Approved
Date submitted
2/11/2016
Date registered
7/11/2016
Date last updated
16/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of sex hormones on one-session cognitive therapy for women with spider phobia. .
Scientific title
The impact of estradiol on cognitive reappraisal in women with spider phobia.
Secondary ID [1] 290446 0
None
Universal Trial Number (UTN)
U1111-1189-3877
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 300812 0
Spider phobia 300813 0
Condition category
Condition code
Mental Health 300635 300635 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One-session cognitive intervention

One-session cognitive intervention for spider phobia is a brief intervention, delivered in a single session and taking between 30-45-mins. It begins with a description of the cognitive model. The relationship between thinking and feeling is demonstrated using an example of a women hearing a loud noise in the night. Participants are provided with a thought monitoring form that consists of three columns: situation (A); belief (B) and consequence (C). With the clinicians assistance participants complete the form demonstrating that emotional and behavioural consequences (column C) are dependent on beliefs (column B) in any given situation. Participants that demonstrate a lack of understanding regarding the relationship between thinking and feeling are provided with another example. Using the same form catastrophic beliefs regarding spiders are then identified (e.g., what goes through your head when you see a live spider? How do you feel and what do you do?) and challenged using cognitive challenging techniques. To assist in challenging beliefs participants are given a Spider Fact Sheet, which contains factual information about spiders, their behaviour and the level of threat they pose to humans.

A clinical psychologist with 8 years experience in providing cognitive-behavioural therapy to people with anxiety disorders will deliver the intervention face to face to each participant individually. Participants will receive the intervention at the UNSW Psychology Clinic.

A clinical psychologist that is blind to the participants’ group and independent from the study will assess intervention adherence via video recordings of the sessions. Feedback regarding good adherence or failure to adhere to the intervention protocol will be provided to maintain or improve fidelity.
Intervention code [1] 296300 0
Treatment: Other
Comparator / control treatment
The low estradiol group will act as the comparator group. Specifically, the results on the outcome measures will be compared between women with low estradiol levels and women with high estradiol levels, based on a serum assay. The groups will be determined based on a median split of serum levels of estradiol..
Control group
Active

Outcomes
Primary outcome [1] 300045 0
Change from baseline in the level of approach on the Behavioural Approach Task (BAT)
Timepoint [1] 300045 0
Pre-treatment, 1-week and 13-weeks post-treatment
Secondary outcome [1] 328916 0
Change from baseline in severity of spider phobia on the Spider Phobia Questionnaire
Timepoint [1] 328916 0
Pre-treatment, and 1 week and 13 weeks post treatment
Secondary outcome [2] 328917 0
Change from baseline in diagnostic criteria meet for specific phobia on the Diagnostic Assessment. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) will be used as the diagnostic criteria.
Timepoint [2] 328917 0
Pre-treatment, and 1 week and 12 weeks post treatment
Secondary outcome [3] 328925 0
Self-reported conviction rating (i.e., as a percentage, how likely it is that the feared outcome will occur)
Timepoint [3] 328925 0
Pre-treatment, and 1 week and 12 weeks post treatment

Eligibility
Key inclusion criteria
Naturally cycling women with spider phobia, aged 18-35
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant, breastfeeding, using hormonal contraceptives, irregular menstrual cycles, endocrinology disorders, psychosis, physical conditions that may be exacerbated by stress (asthma, heart disease)

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Women are allocated into high or low estradiol groups based on their estradiol levels from a serum sample given on the day the intervention is administered. Group allocation is determined using the median split method. All participants receive the same one-session cognitive treatment for spider phobia.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations (GPower) indicate that a sample size of n= 30 participants per group provides adequate power (beta = .8) to detect a medium-large between groups effect size (f = .3) at an alpha level of .05.

2-sample t-tests will compare the change scores (from pre- to post-treatment) for the primary and secondary outcome measures between the high and low estradiol groups. A 2-sample t-test will also compare the percentage of participants no-longer meeting diagnostic criteria between the high and low estradiol groups. Maintenance of treatment gains will be assessed by a repeated measure ANOVA of 1-week and 13-week post-treatment scores for all outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/12/2016
Actual
9/11/2016
Date of last participant enrolment
Anticipated
28/04/2017
Actual
6/07/2017
Date of last data collection
Anticipated
28/07/2017
Actual
9/10/2017
Sample size
Target
60
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294865 0
Charities/Societies/Foundations
Name [1] 294865 0
MQ: Transforming mental health
Country [1] 294865 0
United Kingdom
Primary sponsor type
University
Name
The University of New South Walkes
Address
UNSW Australia
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 293706 0
None
Name [1] 293706 0
Address [1] 293706 0
Country [1] 293706 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296248 0
Human Research Ethics Committee
Ethics committee address [1] 296248 0
UNSW Australia
High St
Kensington, NSW 2052
Australia
Ethics committee country [1] 296248 0
Australia
Date submitted for ethics approval [1] 296248 0
Approval date [1] 296248 0
25/08/2015
Ethics approval number [1] 296248 0
HC15458

Summary
Brief summary
Women are 2-3 times more likely to have an anxiety disorders compared to men. One proposed biological reason for this difference is that changes in sex hormones, particularly, estrogen impact treatment efficacy. The aim of this study is to assess whether sex hormones, particularly estrogen, impact a single-session cognitive intervention for women with spider phobia. Naturally cycling women with spider phobia will receive a one-session cognitive intervention for spider phobia. Outcome measures (scores on the BAT and SPQ, conviction ratings and diagnostic criteria) will be compared for women with high estradiol levels (the main estrogen derivative) versus low estradiol levels as determined by blood serum levels. It is hypothesised that women with high estradaiol levels will have better treatment outcomes compared to women with low estradiol levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70118 0
Dr Sophie Li
Address 70118 0
School of Psychology
UNSW AUSTRALIA
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 70118 0
Australia
Phone 70118 0
+61 2 9385 8657
Fax 70118 0
Email 70118 0
[email protected]
Contact person for public queries
Name 70119 0
Sophie Li
Address 70119 0
School of Psychology
UNSW AUSTRALIA
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 70119 0
Australia
Phone 70119 0
+61 2 9385 8657
Fax 70119 0
Email 70119 0
[email protected]
Contact person for scientific queries
Name 70120 0
Sophie Li
Address 70120 0
School of Psychology
UNSW AUSTRALIA
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 70120 0
Australia
Phone 70120 0
+61 2 9385 8657
Fax 70120 0
Email 70120 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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