Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-10 @ 1:25 AM
Study NCT ID:
NCT04105933
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2019-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturally Sensitive Cognitive Behavioural Therapy for the Survivors of Intimate Partner Violence (IPV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Arab Emirates']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-24', 'studyFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2019-09-25', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological symptoms', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Brief Symptom Inventory (BSI) was used to assess psychological complaints'}], 'secondaryOutcomes': [{'measure': 'Self esteem', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Rosenberg Self-Esteem Scale was used to assess self esteem'}, {'measure': 'Forgiveness', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Heartland Forgiveness Scale was used to assess forgiveness to oneself, to other and to situation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Abuse of Adult', 'Emotional Abuse', 'Domestic Violence']}, 'descriptionModule': {'briefSummary': "Women experience negative psychological outcomes long after the violent relationship has ended. Women suffer constant trauma and psychological distress being in emotional and mentally abusive relationship. Present study developed Culturally sensitive cognitive-behaviour therapy (CBT) to fit the client's cultural identity, context, and preferences."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women victim of intimate partner violence\n* Still in relationship with abuser\n* Willing to attend 16-weeks sessions\n\nExclusion Criteria:\n\n* In need of clinical supervision or treatment\n* Severe mental disorders\n* Cognitive disorders\n* Refused to give written consent'}, 'identificationModule': {'nctId': 'NCT04105933', 'briefTitle': 'Culturally Sensitive Cognitive Behavioural Therapy for the Survivors of Intimate Partner Violence (IPV)', 'organization': {'class': 'OTHER', 'fullName': 'NMP Medical Research Institute'}, 'officialTitle': 'The Effects of Culturally Sensitive Cognitive Behavioural Therapy on Women Experienced Intimate Partner Violence', 'orgStudyIdInfo': {'id': 'NMP/013298'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CS-CBT', 'description': 'Culturally sensitive-CBT intervention was comprised of 16 sessions of cognitive behavioral therapy focused on culturally-specific beliefs and attitude.', 'interventionNames': ['Other: CS-CBT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CBT', 'description': 'CBT intervention was comprised of 16 sessions of cognitive behavioral therapy.', 'interventionNames': ['Other: CBT']}], 'interventions': [{'name': 'CS-CBT', 'type': 'OTHER', 'description': 'Culturally sensitive Cognitive Behavioural Therapy was delivered individually, focused on potential cultural beliefs and attitudes that might collide with core values of CBT.', 'armGroupLabels': ['CS-CBT']}, {'name': 'CBT', 'type': 'OTHER', 'description': 'CBT was delivered at an individual level, dealing with thoughts, feelings and behaviours in the present. Thoughts are identified and then challenged, to make them more objective and rational.', 'armGroupLabels': ['CBT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Būndi', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Gyansaneejvani', 'geoPoint': {'lat': 25.43855, 'lon': 75.63735}}, {'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'NMP Medical Research Institute', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}], 'overallOfficials': [{'name': 'Neha Sharma, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Warwick Research Services'}, {'name': 'Rachana Khandelwal, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'NMP Medical Research Institute, India'}, {'name': 'Anurag Sharma, MPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Patan Girls College, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NMP Medical Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Warwick Research Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}