Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT03427918
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2017-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of the Mindfulness-based Cognitive Therapy (MBCT) on Sexual Functioning in Epileptic Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 660}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2017-12-09', 'studyFirstSubmitQcDate': '2018-02-08', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual functioning', 'timeFrame': 'changes from baseline, 1 Months and 6 months', 'description': 'Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)'}, {'measure': 'Intimacy', 'timeFrame': 'changes from baseline, 1 Months and 6 months', 'description': 'Personal Assessment of Intimacy in Relationships (PAIR) will use to assess relationship satisfaction. The PAIR is a self-reported measure with 36 items which cover five subscales'}, {'measure': 'sexuality-related distress', 'timeFrame': 'changes from baseline, 1 Months and 6 months', 'description': 'The Female Sexual Distress Scale revised version (FSDS-R) is extensively validated and among the most widely used tools to measure sexually related personal distress.'}], 'secondaryOutcomes': [{'measure': 'Mindfulness for sexual functioning', 'timeFrame': 'changes from baseline, 1 Months and 6 months', 'description': 'Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters.'}, {'measure': 'Marital satisfaction', 'timeFrame': 'changes from baseline, 1 Months and 6 months', 'description': 'The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.'}, {'measure': 'Psychological distress', 'timeFrame': 'changes from baseline, 1 Months and 6 months', 'description': 'Hospital Anxiety and Depression Scale (HADS) is a brief self-administrated tool to assess psychological distress in patients as well as general populations'}, {'measure': 'Erectile Function', 'timeFrame': 'changes from baseline, 1 Months and 6 months', 'description': "International Index of Erectile Function Questionnaire (IIEF) is a self-reported and multidimensional measure of male's sexual function"}, {'measure': 'quality of life', 'timeFrame': 'changes of QOLIE-31-P from baseline, 1 Months and 6 months', 'description': "QOLIE-31-P will be used to assess patient's quality of life"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy', 'Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'Female sexual dysfunction (FSD) includes impairments in sexual desire, arousal, orgasm, and genital pain resulting in significant subjective distress. This study is aimed to assess a mindfulness-based intervention for improving sexual functioning among women with epilepsy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 65 years or older\n* Female sexual dysfunctions are categorized by the DSM-5 as sexual interest/arousal disorder, genitopelvic pain/penetration disorder, and female orgasmic disorder. The diagnoses require symptoms to be present for six months or more,\n* Currently in a relationship that has lasted longer than 1 year\n* Both members of the couple are able to speak and read Persian\n* Both members of the couple provide signed and dated informed consent form\n\nExclusion Criteria:\n\n* Cognitive impairment or mental illness that would impair ability to provide consent or participate in the program\n* Major psychiatric disorder (e.g., psychosis, personality disorder)\n* Current suicidal ideation or suicide attempt within past 3 months\n* Past participation in an MBCT program'}, 'identificationModule': {'nctId': 'NCT03427918', 'briefTitle': 'The Effectiveness of the Mindfulness-based Cognitive Therapy (MBCT) on Sexual Functioning in Epileptic Women', 'organization': {'class': 'OTHER', 'fullName': 'Qazvin University Of Medical Sciences'}, 'officialTitle': 'The Effectiveness of the Mindfulness-based Cognitive Therapy (MBCT) on Sexual Functioning in Epileptic Women', 'orgStudyIdInfo': {'id': '1396.169'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient-partner', 'description': 'patients and their partners will receive a weekly Mindfulness-Based Sex Therapy program. The treatments will deliver by a group of facilitators to groups of women consisting of 4-7 women.', 'interventionNames': ['Behavioral: Mindfulness-Based Sex Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'patient-partner and health care providers', 'description': 'patients and their partners as well as health care providers will receive a weekly Mindfulness-Based Sex Therapy program. Th treatments will deliver by a group of facilitators to groups of women consisting of 4-7 women.', 'interventionNames': ['Behavioral: Mindfulness-Based Sex Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will receive a routine counseling'}], 'interventions': [{'name': 'Mindfulness-Based Sex Therapy', 'type': 'BEHAVIORAL', 'description': 'Mindfulness-Based Sex Therapy in an integration of psychoeducation, sex therapy, and mindfulness-based skills.', 'armGroupLabels': ['patient-partner', 'patient-partner and health care providers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karaj', 'country': 'Iran', 'facility': 'Abbasi', 'geoPoint': {'lat': 35.83266, 'lon': 50.99155}}, {'city': 'Karaj', 'country': 'Iran', 'facility': 'Brain and Neuropsychological Clinic', 'geoPoint': {'lat': 35.83266, 'lon': 50.99155}}, {'city': 'Karaj', 'country': 'Iran', 'facility': 'Shahid Madani', 'geoPoint': {'lat': 35.83266, 'lon': 50.99155}}, {'city': 'Karaj', 'country': 'Iran', 'facility': 'Shahid Rejaei', 'geoPoint': {'lat': 35.83266, 'lon': 50.99155}}, {'zip': '3419759811', 'city': 'Qazvin', 'country': 'Iran', 'facility': 'Mehregan', 'geoPoint': {'lat': 36.26877, 'lon': 50.0041}}, {'city': 'Qazvin', 'country': 'Iran', 'facility': 'Razi Hospital', 'geoPoint': {'lat': 36.26877, 'lon': 50.0041}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Attar clinic', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Baharlu Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Lolagar Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Raha', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Rasoul Akram Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Rezaei Clinic', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Sadaf', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Sina', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Ziaeian', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qazvin University Of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Social Determinants of Health Research Center (SDH)', 'investigatorFullName': 'Amir H Pakpour', 'investigatorAffiliation': 'Qazvin University Of Medical Sciences'}}}}