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Completed

NCT Number: NCT06206460

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

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.

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Key information

Conditions

Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

Female

Study type

Observational

Primary location

University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy

Basel, 4055, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Online Assessment

Other

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

Primary outcomes

  1. Symptom intensity of premenstrual syndrome

    Time frame: 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.

  2. Interference of premenstrual syndrome

    Time frame: 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 outcomes

  1. Quality of life (Short-Form-12)

    Time frame: 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.

  2. Partnership satisfaction (Zufriedenheit in der Partnerschaft: ZIP)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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