Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:15 PM
Study NCT ID:
NCT06206460
Status:
COMPLETED
Last Update Posted:
2024-08-16
First Post:
2024-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up Assessment of a Trial of Open-label Placebos for Women With Premenstrual Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011293', 'term': 'Premenstrual Syndrome'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2024-01-04', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': '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.'}, {'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)', 'description': '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).\n\nThe 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.'}], 'secondaryOutcomes': [{'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)', 'description': '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.'}, {'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)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Premenstrual Syndrome', 'Open-label Placebo', 'RCT follow up'], 'conditions': ['Premenstrual Syndrome']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants are willing to participate in the follow-up study\n* Participants have the ability to use an electronic device with internet access to complete the online follow-up survey\n* Participants give Informed consent\n* Participants have a regular menstruation (i.e., no menopause; pregnancy; cycle inhibiting medication etc.)\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding (currently or within the last three months)\n* A severe psychological or somatic disease, affecting premenstrual complaints (e.g., cancer of the uterus or fallopian tubes)\n* Commencement of the menopause, sterilization, or (part) resection of the uterus or fallopian tubes\n* Changes in body mass index (i.e., under 18 or above 30)'}, 'identificationModule': {'nctId': 'NCT06206460', 'briefTitle': 'Follow-up Assessment of a Trial of Open-label Placebos for Women With Premenstrual Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Follow-up Assessment of the Randomized Controlled Trial: Open-label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2023-02187; ub24Frey'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Open Label Placebo with Treatment Rationale', 'interventionNames': ['Other: Online Assessment']}, {'label': 'Open Label Placebo without Treatment Rationale', 'interventionNames': ['Other: Online Assessment']}], 'interventions': [{'name': 'Online Assessment', 'type': 'OTHER', 'description': 'Online Assessment which consists of:\n\n* Sociodemographic data (life changes, medical and gynaecological history)\n* German PMS symptom diary retrospectively for last menstrual cycle\n* Quality of Life Inventory (SF-12)\n* Expectancy of relief', 'armGroupLabels': ['Open Label Placebo with Treatment Rationale', 'Open Label Placebo without Treatment Rationale']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4055', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}