None listed
Conditions
Brief 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).
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 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 b
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.
Sponsors
University of New South Wales
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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).
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.
Outcome results
None listed