RecruitingACTRN12623001094662

Exploring the impact of hormonal contraceptives on the treatment of claustrophobia in women

A quasi-controlled trial investigating the efficacy of exposure therapy for claustrophobia in women taking hormonal contraceptives versus those who are naturally cycling.


Sponsor

University of New South Wales

Enrollment

69 participants

Start Date

Jul 8, 2024

Study Type

Interventional

Conditions

Summary

This non-randomised controlled trial seeks to determine the association between use of different hormonal contraceptives and the outcomes of a brief, cognitive behavioural treatment for claustrophobia in a sample of women with at least moderate claustrophobia symptoms. Treatment outcomes from women taking the combined oral contraceptive pill, and those taking progestin hormonal contraceptives (including the progestin only pill, the hormonal contraceptive injection, and the hormonal IUD) will be compared to those from women who are not taking hormonal contraceptives and have regular menstrual cycles. Changes in behavioural and self-reported claustrophobic symptoms will be compared between these groups from pre to post treatment (one week after treatment, and one month after treatment).


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

Claustrophobia — a fear of enclosed spaces — affects many people and can interfere with daily life, medical procedures like MRI scans, and even simple activities like using lifts. A short form of cognitive behavioural therapy (CBT) is an effective treatment, but interestingly, the hormones in a woman's body may affect how well this therapy works. This study is investigating whether the type of hormonal contraceptive a woman uses influences her response to a brief CBT treatment for claustrophobia. Women using the combined pill (which contains both oestrogen and progestins), women using progestin-only contraceptives (like the mini-pill, the injection, or a hormonal IUD), and women not using hormonal contraceptives will each be compared. You may be eligible if you are a woman (biological female) aged 18–45 with at least moderate claustrophobia symptoms, and you either have regular menstrual cycles or are using a hormonal contraceptive. You should not have a diagnosis of schizophrenia, bipolar disorder, or severe depression, and must not currently be in therapy for claustrophobia.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

NSW, Australia

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ACTRN12623001094662


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