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

Premenstrual Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206460
• Other study ID #: 2023-02187; ub24Frey
• Status: Recruiting
• Start date: January 4, 2024
• Est. completion date: January 4, 2026

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Antje F Nascimento, PhD
• Phone: (+41) 061 207 02 12
• Email: antje.freynascimento[@]unibas.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: January 4, 2026
• Est. primary completion date: January 4, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participants are willing to participate in the follow-up study
• Participants have the ability to use an electronic device with internet access to complete the online follow-up survey
• Participants give Informed consent
• Participants have a regular menstruation (i.e., no menopause; pregnancy; cycle inhibiting medication etc.)

Exclusion Criteria:

• Pregnancy or breastfeeding (currently or within the last three months)
• A severe psychological or somatic disease, affecting premenstrual complaints (e.g., cancer of the uterus or fallopian tubes)
• Commencement of the menopause, sterilization, or (part) resection of the uterus or fallopian tubes
• Changes in body mass index (i.e., under 18 or above 30)

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Switzerland	University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom intensity of premenstrual syndrome	The items of the German PMS [Premenstrual Syndrome] Symptom diary will be used to measure symptom intensity retrospectively for the last luteal phase ( i.e., PMS phase). The scale consists of 27 items measured on a 6-point Likert scale. A decrease in scores indicates an improvement in symptom intensity. The minimum score is zero; the maximum 162.	One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)
Primary	Interference of premenstrual syndrome	The items of the German PMS [Premenstrual Syndrome] Symptom diary will be used to measure interference retrospectively for the last luteal phase ( i.e., PMS phase).; The scale consists of 3 items measured on a 6-point Likert scale. A decrease in scores indicates an improvement in interference. The minimum score is zero; the maximum 162.	One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)
Secondary	Quality of life (Short-Form-12)	Quality of life will be measured by means of the SF-12 (Short-Form-12) questionnaire retrospectively for the last luteal phase (i.e., PMS phase). The questionnaire comprises 12 questions, and quality of life is measured on a 6-point Likert scale. Two summary scores can be calculated: a mental component and a physical component score. Scores range from 0-100, with higher scores indicating better functioning.	One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)
Secondary	Partnership satisfaction (Zufriedenheit in der Partnerschaft: ZIP)	Partnership satisfaction will be measured by means of the ZIP (Zufriedenheit in der Partnerschaft) questionnaire retrospectively for the last luteal phase (i.e., PMS phase). The questionnaire comprises 7 questions, and partnership satisfaction is measured on a 5-point rating scale. Scores range from 7 to 35.	One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)