Study periods | Screening phase | Intervention phase | ||||||
Preliminary screening of eligibility | Prospective PMS screening | L1 OA | Personal meeting (t0) | L2 OA | Midpoint study contact | L3 OA | Post-treatment study contact & OA (t2) | |
Visit/contact | Phone/post/online | At home (diary form) | Online | At study site | Online | At study site or phone/Skype | Online | Phone +post-treatment online |
Day of menstrual cycle (MC) | −31–−1 day of 1. MC | 1. day of 1. MC until end of 1. MC | −5–−1 of 2. MC | 1–14 day of 2. MC | −5–−1 of 3. MC | 1–14 day of 3. MC | −5–−1 of 4. MC | 1–14 day of 4. MC |
Menstrual phase | At any point | One whole MC | Luteal | Follicular | Luteal | Follicular | Luteal | Follicular |
Time (min) | 20 | 2 daily for 1 MC | 10 | 60 | 10 | 15 | 10 | 30 |
Study information/informed consent | x | |||||||
Inclusion/exclusion criteria | x | x | x | |||||
Randomisation | x | |||||||
Placebo dragée intake in intervention arms | x | x | x | x | ||||
Narrative for OLP+ group | x | x | ||||||
Primary outcome | ||||||||
PMS symptom diary | x | x | x | x | x | x | ||
Safety variables | x | x | x | x | x | |||
Suicidality assessment | x | x | x | x | ||||
Side-effects assessment | x | x |
L, luteal phase; OA, online assessment; OLP, open-label placebo; PMS, premenstrual syndrome.