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

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University Hospital Basel

Status

Enrolling

Conditions

Premenstrual Syndrome

Treatments

Other: Online Assessment

Study type

Observational

Funder types

Other

Identifiers

NCT06206460
2023-02187 ub24Frey;

Details and patient eligibility

About

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.

Enrollment

95 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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)

Trial design

95 participants in 2 patient groups

Open Label Placebo with Treatment Rationale
Treatment:
Other: Online Assessment
Open Label Placebo without Treatment Rationale
Treatment:
Other: Online Assessment

Trial contacts and locations

1

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Central trial contact

Antje F Nascimento, PhD

Data sourced from clinicaltrials.gov

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