Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001094662
Ethics application status
Approved
Date submitted
20/09/2023
Date registered
18/10/2023
Date last updated
21/07/2024
Date data sharing statement initially provided
18/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the impact of hormonal contraceptives on the treatment of claustrophobia in women
Scientific title
A quasi-controlled trial investigating the efficacy of exposure therapy for claustrophobia in women taking hormonal contraceptives versus those who are naturally cycling.
Secondary ID [1] 310599 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Claustrophobia 331476 0
Anxiety Disorders 331477 0
Panic Disorder 331478 0
Condition category
Condition code
Mental Health 328204 328204 0 0
Anxiety
Reproductive Health and Childbirth 328401 328401 0 0
Contraception
Mental Health 328402 328402 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be 1 hour of cognitive behavioural therapy for for claustrophobia. This will be delivered to each participant individually in a single, 1 hour, face-to-face session, including 45 minutes of exposure therapy, located in the research facilities in the School of Psychology at UNSW. This is the same location at which the in person behavioural approach test (Primary outcome) is to be measured.

Treatment will be delivered by a registered psychologist, with supervision provided by a registered clinical psychologist. The treatment session will involve psychoeducation (15 minutes) and exposure therapy (45 minutes). Participants will be provided with information regarding the causes of claustrophobic anxiety, and how catastrophic thoughts and avoidance behaviour perpetuate anxiety. Then they will complete an exposure therapy task, which involves entering and remaining in a claustrophobic situation (e.g., a walk-in cupboard) with clinician support, in order to overcome avoidance and test catastrophic beliefs.

Prior to the intervention, participants will undergo a diagnostic assessment interview conducted by a registered psychologist. Participants will complete a measure of claustrophobic anxiety symptoms, depression, before the treatment session (baseline), one week after the treatment session (one week post baseline), and at 1-month follow-up (four weeks post baseline).

Participants in the intervention group will be comprised of women taking one of two forms of hormonal contraceptive - either the combined oral contraceptive pill, or a progestin-only hormonal contraceptive (including the progestin only oral pill, a hormonal contraceptive injection, or a hormonal intrauterine device). Participants will need to be on hormonal contraceptives continuously for at least 1 month prior to the intervention.

Note that there will be two intervention groups - one group taking the combined oral contraceptive pill, and the other group taking a progestin-only hormonal contraceptive.
Intervention code [1] 327009 0
Behaviour
Intervention code [2] 327138 0
Treatment: Other
Comparator / control treatment
The comparator group is comprised of women with claustrophobia who are naturally cycling (i.e, have regular menstrual cycles without taking any hormonal contraception). They will receive an identical cognitive behavioural treatment as the two hormonal contraceptive intervention groups, and they will allow comparisons to be made between the efficacy of this treatment as a function of hormonal contraceptive status.
Control group
Active

Outcomes
Primary outcome [1] 336081 0
Changes in avoidance of enclosed places, as measured by an in-person behavioural approach test (ability to enter an enclosed space), which will be conducted at the School of Psychology at UNSW.
Timepoint [1] 336081 0
Baseline, one week post-treatment (one week post-baseline), and one-month post-treatment (one-month post-baseline, primary timepoint).
Primary outcome [2] 336082 0
Changes in self-reported claustrophobia symptoms, as measured by the Claustrophobia Questionnaire (CLQ) (Radomsky et al 2001)
Timepoint [2] 336082 0
Baseline, one week post-treatment (one week post-baseline), one-month post-treatment (one month post-baseline, primary timepoint).
Secondary outcome [1] 426782 0
Changes in claustrophobic cognitions, as measured by the claustrophobia coping self-efficacy scale (CCSES) (Valentiner et al 1996)
Timepoint [1] 426782 0
Baseline, one week post-treatment (one week post-baseline), one-month post-treatment (one month post-baseline).
Secondary outcome [2] 427493 0
Changes in claustrophobic cognitions, as measured by the claustrophobia concerns questionnaire (CCQ) (Valentiner et al 1996)
Timepoint [2] 427493 0
Baseline, one week post-treatment (one week post-baseline), one-month post-treatment (one month post-baseline).

Eligibility
Key inclusion criteria
1) Female (biological sex not gender) with either regular menstrual cycles or currently using a hormonal contraceptive that contains a combination of estrogens and progestins, or exclusively progestins.
2) At least moderate claustrophobic fear, must meet all DSM criteria for specific phobia (claustrophobic subtype) except functional impairment/marked distress (Criterion F).
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Male sex
2) Irregular or absent menstrual cycles in the absence of hormonal contraceptive use, or those who are/have been pregnant or breastfeeding within the last three months
3) Does not meet criteria for moderate claustrophobic fear
4) Self-reported diagnosis of schizophrenia, bipolar disorder, substance use disorder, or current psychotic symptoms.
5) Current suicidal ideation (deemed as responding 1 or greater to the PHQ-9 question 9 item that assesses the frequency of suicidal ideation).
6) Severe or very severe depression (PHQ-9 scores of 20 and above)
7) Commencement of a new mental health medication or change in dose of existing mental health medication in the two months prior to intake.
8) Currently participating in Cognitive Behavioural Therapy for claustrophobia.
9) Does not complete the online screening questionnaire or unwilling to provide details regarding hormonal contraceptive use and menstrual cycle.

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 administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
There will be 23 participants enrolled in each of the three groups (the two intervention groups; which are 1) those taking the combined oral contraceptive pill, and 2) those taking a progestin only contraceptive, and 3) the one control group). Data will be analysed via intention to treat linear mixed model analyses and one-way ANOVA followed by student-newman-kuels test. Unadjusted and adjusted mixed models will be used (controlling for appropriate covariates). Categorical variables will be compared using chi square analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
69
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314813 0
Charities/Societies/Foundations
Name [1] 314813 0
Liptember Foundation
Country [1] 314813 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Psychology, University of New South Wales, Gate 11, Botany St, Randwick NSW 2052
Country
Australia
Secondary sponsor category [1] 316802 0
None
Name [1] 316802 0
Address [1] 316802 0
Country [1] 316802 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313818 0
The UNSW Human Research Ethics Committee
Ethics committee address [1] 313818 0
Ethics committee country [1] 313818 0
Australia
Date submitted for ethics approval [1] 313818 0
15/11/2023
Approval date [1] 313818 0
22/01/2024
Ethics approval number [1] 313818 0
iRECS4594

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129442 0
Prof Bronwyn Graham
Address 129442 0
School of Psychology, University of New South Wales, Gate 11, Botany St, Randwick NSW 2052
Country 129442 0
Australia
Phone 129442 0
+61 2 9065 9703
Fax 129442 0
Email 129442 0
[email protected]
Contact person for public queries
Name 129443 0
Bronwyn Graham
Address 129443 0
School of Psychology, University of New South Wales, Gate 11, Botany St, Randwick NSW 2052
Country 129443 0
Australia
Phone 129443 0
+61 2 9065 9703
Fax 129443 0
Email 129443 0
[email protected]
Contact person for scientific queries
Name 129444 0
Bronwyn Graham
Address 129444 0
School of Psychology, University of New South Wales, Gate 11, Botany St, Randwick NSW 2052
Country 129444 0
Australia
Phone 129444 0
+61 2 9065 9703
Fax 129444 0
Email 129444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy of participants


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.