Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-31 @ 7:22 PM
Study NCT ID:
NCT06490094
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of IBSR on Postpartum Mothers' Mental Health.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-29', 'studyFirstSubmitDate': '2024-06-29', 'studyFirstSubmitQcDate': '2024-06-29', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Primary Care PTSD DSM-5', 'timeFrame': 'A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)', 'description': 'Questionnaire'}, {'measure': 'exposure to the events of the war in Israel', 'timeFrame': 'A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)', 'description': 'Questionnaire'}, {'measure': 'Demographic and Childhood history', 'timeFrame': 'A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)', 'description': 'Questionnaire'}], 'primaryOutcomes': [{'measure': 'Perceived Stress Scale (PSS)', 'timeFrame': 'A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)', 'description': 'Questionnaire'}, {'measure': 'Generalized Anxiety Disorder 7-Item Scale (GAD-7)', 'timeFrame': 'A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)', 'description': 'Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Emotion Regulation Questionnaire (ERQ)', 'timeFrame': 'A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)', 'description': 'Questionnaire'}, {'measure': 'Connor-Davidson Resilience Scale (2-item CD-RISC)', 'timeFrame': 'A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)', 'description': 'Questionnaire'}, {'measure': 'Ryff scale- Psychological well-being (PWB)', 'timeFrame': 'A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)', 'description': 'Questionnaire'}, {'measure': 'Subjective well-being (WHO-5)', 'timeFrame': 'A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)', 'description': 'Questionnaire'}, {'measure': 'Multidimensional Scale of Perceived Social Support (MSPSS)', 'timeFrame': 'A measure assessing change between 3 time points (before the intervention, after 2 months (at the end of the intervention) and 1 months later)', 'description': 'Questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Mothers']}, 'descriptionModule': {'briefSummary': 'The period of pregnancy, childbirth, and the postpartum phase significantly impacts the mental health of women and their families. Mental health is crucial for overall well-being, quality of life, and is associated with healthcare costs. Therefore, promoting mental health should be a top priority in public health and health promotion efforts.\n\nThe Inquiry-Based Stress Reduction (IBSR) intervention, developed by Byron Katie ("The Work"), enables participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR involves a contemplative "inquiry" process and a "turnaround," which is a method of experiencing the opposite of what the participant believes. This process equips individuals with skills for self-inquiry and management of stressful thoughts that can be easily integrated into daily life.\n\nBased on previous research, we hypothesize that the IBSR intervention can improve postpartum mothers\' mental health.', 'detailedDescription': 'In recent years, there is growing evidence regarding the effectiveness of population-based mental health promotion interventions. Developing social and emotional skills such as improved self-esteem, sense of control and self-efficacy, self-acceptance, purpose in life, positive relationships with others, problem-solving, and coping skills has been shown to improve mental health and contribute to psychological well-being. According to the International Union for Health Promotion and Education (IUHPE, 2021), interventions to promote mental health can be classified into eight priority areas. The first priority is to promote the mental health of infants and mothers by focusing on social and emotional development and positive mental health in early childhood development services, including prenatal care, home visits, and parenting programs. The healthcare system today faces the challenge of gaining a better understanding of the mechanisms that allow women to develop and maintain positive mental health in the postpartum period and understanding how these mechanisms are sustained over time.\n\nThe Inquiry-Based Stress Reduction (IBSR) intervention, developed by Byron Katie ("The Work"), enables participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR involves a contemplative "inquiry" process and a "turnaround," which is a method of experiencing the opposite of what the participant believes. This process equips individuals with skills for self-inquiry and management of stressful thoughts that can be easily integrated into daily life. Based on previous research, we hypothesize that the IBSR intervention can improve postpartum mothers\' mental health.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'postpartum mothers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers up to two years after giving birth, between the ages of 18 and 45 (at the time of birth), without a history of mental disorders or illnesses\n\nExclusion Criteria:\n\n* Mothers with a history of illness or mental disorders\n* mothers who have passed more than two years since their last birth'}, 'identificationModule': {'nctId': 'NCT06490094', 'briefTitle': "Impact of IBSR on Postpartum Mothers' Mental Health.", 'organization': {'class': 'OTHER', 'fullName': 'Tel Aviv University'}, 'officialTitle': "Impact of Inquiry-Based Stress Reduction (IBSR) on Postpartum Mothers' Mental Health.", 'orgStudyIdInfo': {'id': 'IBSR Postpartum Mothers'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inquiry Based Stress Reduction', 'description': 'Inquiry Based Stress Reduction (IBSR) program', 'interventionNames': ['Behavioral: Inquiry Based Stress Reduction (IBSR)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Postpartum mothers who are randomly assigned to not receive the Inquiry-Based Stress Reduction (IBSR) intervention'}], 'interventions': [{'name': 'Inquiry Based Stress Reduction (IBSR)', 'type': 'BEHAVIORAL', 'description': 'The 8-week IBSR program is a clinical intervention based on "The Work" method, developed by Byron Katie and run in the US and Europe for 35 years. The IBSR intervention will involve weekly group meetings (3 hours/meeting) throughout 8 weeks. Home practice between sessions will be supported by facilitator assistants (1-hour session per week). All sessions will be standardized according to the IBSR certification program guidelines and will be assessed to maintain consistency in the program, as in previous studies. .', 'armGroupLabels': ['Inquiry Based Stress Reduction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'shirly mor anavy, MPH', 'role': 'CONTACT', 'email': 'shirlymor30@gmail.com', 'phone': '+972-50-7652030'}], 'facility': 'Tel Aviv University', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Shahar Lev- Ari, PhD', 'role': 'CONTACT', 'email': 'leva@tauex.tau.ac.il', 'phone': '+972-3-6409040'}, {'name': 'shirly mor-anavy, MPH', 'role': 'CONTACT', 'email': 'shirlymor30@gmail.com', 'phone': '+972-50-7652030'}], 'overallOfficials': [{'name': 'Shahar Lev- Ari, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel Aviv University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Impact of Inquiry-Based Stress Reduction (IBSR) on Postpartum Mothers' Mental Health.", 'investigatorFullName': 'shahar lev-ari', 'investigatorAffiliation': 'Tel Aviv University'}}}}