Premenstrual SyndromeNCT06206460
Follow-up Assessment of a Trial of Open-label Placebos for Women With Premenstrual Syndrome
An observational study of Premenstrual Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Online Assessment
- How many people
- 66 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Jan 2024to 3 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy
Basel, 4055
About this study
Official title: 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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Online Assessment
- Keywords
- Premenstrual Syndrome, Open-label Placebo, RCT follow up
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online AssessmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Open Label Placebo with Treatment Rationale | Not described Receives: Other: Online Assessment | |
| Open Label Placebo without Treatment Rationale | Not described Receives: Other: Online Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)
Secondary outcomes (2)
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.
Measured: 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.
Measured: One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start4 Jan 2024
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206460
- Sponsor's protocol ID
- 2023-02187; ub24Frey
- Other IDs
- 2023
- Status last verified
- Aug 2024
- First submitted
- 4 Jan 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Assessment of the Randomized Controlled Trial: Open-label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06206460
- Acronym / sponsor ID
- 2023-02187; ub24Frey
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual Syndrome, Open-label Placebo, RCT follow up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Label Placebo with Treatment Rationale | – | Other: Online Assessment |
| Open Label Placebo without Treatment Rationale | – | Other: Online Assessment |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online AssessmentOnline 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 | Other | Open Label Placebo with Treatment Rationale, Open Label Placebo without Treatment Rationale |
Primary outcome
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.
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.
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premenstrual Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.