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

Completed

• Conditions: Premenstrual Syndrome
• Interventions: Other: Online Assessment

• Registration Number: NCT06206460
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-04
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-16
• Primary Completion: 2024-07-03
• Study Completion: 2024-07-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open Label Placebo with Treatment Rationale	Online Assessment	-
Open Label Placebo without Treatment Rationale	Online Assessment	-

Primary Outcome Measures

Name	Time	Method
Symptom intensity of premenstrual syndrome	One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)	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.
Interference of premenstrual syndrome	One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life (Short-Form-12)	One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)	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.
Partnership satisfaction (Zufriedenheit in der Partnerschaft: ZIP)	One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)	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.

Trial Locations

Locations (1)

University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy; 🇨🇭 Basel, Switzerland