Clinical trial NCT06206460: Follow-up Assessment of a Trial of Open-label Placebos for Women With Premenstrual Syndrome
Official title: Follow-up Assessment of the Randomized Controlled Trial: Open-label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premenstrual Syndrome
Keywords: Premenstrual Syndrome
Open-label Placebo
RCT follow up
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 66
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Symptom intensity of premenstrual syndrome
timeFrame: One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)
measure: Interference of premenstrual syndrome
timeFrame: One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)
Secondary outcomes:
measure: Quality of life (Short-Form-12)
timeFrame: One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)
measure: Partnership satisfaction (Zufriedenheit in der Partnerschaft: ZIP)
timeFrame: One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy
Study officials:
References: