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

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.

Study Overview

• Status: Recruiting
• Conditions: Premenstrual Syndrome
• Intervention / Treatment: Other: Online Assessment

• Study Type: Observational
• Enrollment (Estimated): 95

Contacts and Locations

• Study Contact: Name: Antje F Nascimento, PhD; Phone Number: (+41) 061 207 02 12; Email: antje.freynascimento@unibas.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4055
    • Recruiting
    • University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy
    • Contact: Antje F Nascimento, PhD; Phone Number: (+41) 061 207 02 12; Email: antje.freynascimento@unibas.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

95 women who participated in the intervention groups of the RCT OPEN-LABEL PLACEBO TREATMENT OF WOMEN WITH PREMENSTRUAL SYNDROME: A RANDOMIZED CONTROLLED TRIAL (OLPPMS_1, SNCTP000002809, NCT03547661) and completed study participation (OLP+: N=48 and OLP-: N=47).

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open Label Placebo with Treatment Rationale	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
Open Label Placebo without Treatment Rationale	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2024
• Primary Completion (Estimated): January 4, 2026
• Study Completion (Estimated): January 4, 2026

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Premenstrual Syndrome; Open-label Placebo; RCT follow up
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Menstruation Disturbances; Syndrome; Premenstrual Syndrome
• Other Study ID Numbers: 2023-02187; ub24Frey

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No