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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Placebo with Treatment Rationale |
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| Open Label Placebo without Treatment Rationale |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Assessment | Other | Online Assessment which consists of:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy | Basel | 4055 | Switzerland |
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| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. | One time assessment at baseline (the start day 1-3 of the next menstrual cycle retrospectively for the last luteal phase) |