Identifying sex differences in interoception (i.e. the perception of the internal state of the body), common mental health disorders (i.e. anxiety, depression) and mood, and somatic complaints (i.e. physical symptoms), and identifying whether the menstrual cycle may contribute to these differences. Mental and Behavioural Disorders
Conditions
Interventions
For ~7 months, both female and male participants will use a specially designed smartphone app to track their daily and weekly mood, mental health, and physical symptoms, including menstrual cycle info
Sponsors
University of Surrey
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Sex assigned female or male at birth 2. 18-40 years old 3. Have an iPhone 7 or above with iOS 13 or above (for compatibility with the smartphone app) 4. Have sufficient fluency in English (for comprehension of task instructions) 5. Based in the UK or an EU country 6. Provide informed consent For full list of exclusion criteria, see Participant Exclusion Criteria below.
Exclusion criteria
Exclusion criteria: Both sexes: 1. Impaired vision or hearing 2. Neurological or cardiac abnormalities 3. Taking psychiatric medication/s for less than 6 months 4. Above threshold for severe anxiety sensitivity as measured by the Physical Concerns subscale of the Anxiety Sensitivity Index 5. Undergoing or awaiting to undergo sex-reassignment hormone therapy or surgery (in the next 6 months) Females only: 1. Not currently pregnant or breastfeeding (or pregnant in the last 12 months) 2. Not undergoing (or planning in the next 6 months) changes to their reproductive function that include: hysterectomy, ovarian surgery, IVF treatment, gender transitioning hormone treatment/s (i.e. testosterone) 3. No current (or a history of) hypothyroidism or hyperthyroidism 4. No current (or a history of) pelvic complaints that include: fibroids on the uterus, ovarian cysts, endometriosis, pelvic inflammatory disease, intermittent or constant pain in the lower abdomen in the last 6> months 5. No primary amenorrhoea (i.e. never experienced a menstrual cycle) 6. Provide informed consent to record menstrual cycle information To compare menstrual cycle effects, females will be grouped by hormonal contraception status with the following inclusion criteria. Eligible naturally cycling females are those: 1. Not taking any hormonal contraception for at least 6 months 2. No history of secondary amenorrhoea (3 months or more without a period) within the last 12 months 3. Whose cycle length is considered regular on the basis of their tracking Eligible females taking hormonal contraception are those: 1. Taking hormonal contraception for at least 6 months or more
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interoceptive accuracy will be measured using: 1. Scores from the Interoceptive Accuracy Scale, measured at baseline, weekly intervals and items reported daily (experienced sampling method). 2. Scores from a Phase Adjustment Task (PAT) at baseline and at weekly intervals. 3. Scores on weekly lab-based tasks assessed at weekly intervals 3.1. Cardiac interoceptive accuracy (Phase Adjustment Task) 3.2. Respiratory interoceptive accuracy (a Respiratory Resistance Detection task) 3.3. The degree of convergence between observed autonomic response (cardiovascular activity, skin conductance) and perceived arousal during exposure to affective images. Interoceptive attention will be measured using: 1. Scores from items on the Interoceptive Attention Scale, at baseline and daily/weekly intervals. Mental health (anxiety, depression, stress) will be measured using: 1. Scores on momentary mood items reported daily (experience sampling method). 2. Scores on validated questionnaires taken at baseline and weekly intervals. Regarding questionnaires, anxiety and depression will be measured using the Hospital and Depression Scale, and the Anxiety Sensitivity Index (ASI-3). Stress will be measured using the Perceived Stress scale (PSST-8). Physical symptoms will be measured using items from the Somatic Symptoms Scale and Premenstrual Symptoms Screening Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Emotion regulation will be measured using: 1.1. Scores on the Difficulties in Emotion Regulation Scale assessed at weekly intervals 1.2. Scores on items taken from Emotion Regulation Questionnaire reported daily (experience sampling method) 1.3. Modulation of physiological arousal in lab-based task assessed at weekly intervals (in a subsample after 12 weeks of study start) 2. Obsessive Compulsive tendencies will be measured using scores on items from the OCI-4 reported at daily/weekly intervals 3. Sexual health (sexual activity and sexual desire) will be measured using scores from self-developed items reported daily (experience sampling method) 4. Alexithymia will be measured using scores on the Toronto Alexithymia Scale (TAS-20) at baseline and at the end 5. Intolerance of Uncertainty will be measured using scores on the Intolerance of Uncertainty scale (IUS-12) at baseline and at the end 6. Self-efficacy will be measured using scores on the Rosenberg Self-efficacy Scale (Rosenberg, 1965) at baseline and at the end 7. Paranoia will be measured using scores on the Revised Green et al. Paranoid Thoughts Scale (R-GPTS) at baseline and at the end as well as via daily reports (experience sampling method) | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, England, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom
Contacts
Public ContactRosie Donaghy
Outcome results
None listed