NCT06206460

Follow-up Assessment of a Trial of Open-label Placebos for Women With Premenstrual Syndrome

Follow-up Assessment of the Randomized Controlled Trial: Open-label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 66 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

With the proposed study, the investigators aim to evaluate the long-term efficacy of the open-label placebo (OLP) intervention in premenstrual syndrome (PMS) and to contribute to a broader understanding of how OLPs work. It is planned to survey participants of the intervention groups (OLP+ and OLP-) regarding symptom intensity and impairment due to PMS after the conclusion of our randomized controlled trial (RCT) and intervention provision. Additionally, it will be examined if there is a difference between the OLP group with and without a treatment rationale (OPL+ vs. OLP-) across time. More precisely, it will be investigated whether participants of the intervention groups with and without treatment rationale experience any long-term improvement.

Conditions

• Premenstrual Syndrome

Interventions

Type	Name	Description
OTHER	Online Assessment	Online Assessment which consists of: * Sociodemographic data (life changes, medical and gynaecological history) * German PMS symptom diary retrospectively for last menstrual cycle * Quality of Life Inventory (SF-12) * Expectancy of relief

Timeline

• Start date: 2024-01-04
• Primary completion: 2024-07-03
• Completion: 2024-07-03
• First posted: 2024-01-16
• Last updated: 2024-08-16

Locations

1 site across 1 country: Switzerland