Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:55 PM
Study NCT ID:
NCT01531634
Status:
UNKNOWN
Last Update Posted:
2012-02-13
First Post:
2012-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Recovery Processes in Women With Borderline Personality Disorder Using a Dynamic Cognitive Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'lastUpdateSubmitDate': '2012-02-08', 'studyFirstSubmitDate': '2012-02-03', 'studyFirstSubmitQcDate': '2012-02-08', 'lastUpdatePostDateStruct': {'date': '2012-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Recovery Assessment Scale', 'timeFrame': 'Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks)', 'description': 'A baseline Recovery Assessment Scale will be used on the first intervention group meeting. Recovery Assessment Scale will be used again on the last (i.e. 12th) intervention group meeting.'}], 'secondaryOutcomes': [{'measure': 'Change in Hope Scale', 'timeFrame': 'Change from baseline in Hope Scale at 12th meeting (6 up to 12 weeks)', 'description': 'A baseline Hope Scale will be used on the first intervention group meeting. Hope Scale will be used again on the last (i.e. 12th) intervention group meeting.'}, {'measure': 'Change in Brief Symptom Inventory', 'timeFrame': 'Change from baseline in Brief Symptom Inventory at 12th meeting (6 up to 12 weeks)', 'description': 'A baseline Brief Symptom Inventory will be used on the first intervention group meeting. Brief Symptom Inventory will be used again on the last (i.e. 12th) intervention group meeting.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Borderline Personality Disorder', 'Women', 'Dynamic Cognitive Intervention', 'Recovery', 'Hope Scale'], 'conditions': ['Borderline Personality Disorder']}, 'referencesModule': {'references': [{'pmid': '32368793', 'type': 'DERIVED', 'citation': 'Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.'}]}, 'descriptionModule': {'briefSummary': "The field of psychiatric rehabilitation focuses on creating a personal narrative and developing coping strategies and environmental supports. The concept of recovery is person-centered and emphasizes the person's ability to change and to live meaningful life. The strengths approach has a central role in the recovery concept, emphasizing the person's abilities and potential. A preserved cognitive ability can be a significant strength in the recovery process.\n\nResearch had shown growing support for the use of cognitive-behavioral approaches as the most effective therapy for people with borderline personality disorder, using structured interventions. A central focus in cognitive therapy is the change of maladaptive schemes. The dynamic-cognitive intervention (DCI) is based on the understanding of structural cognitive modifiability and suggests the use of mediated learning in order to enhance sense of competence and develop better psychological coping skills.\n\nThe present study will focus on women diagnosed with borderline personality disorder, with normative cognitive ability seen as a strength as opposed to their emotional ability. This study will examine the effects of a Dynamic Cognitive Intervention on recovery measures and on symptoms severity.\n\nThe study will include 30 women aged 18-45 years. Participants will be randomly assigned to an intervention group and a control group. All participants will be assessed before and after intervention using Recovery Assessment Scale, Hope Scale and The Brief Symptom Inventory.\n\nThe intervention designed for this study is based on the principles of the Dynamic Cognitive Intervention. The intervention tools that will be used include: a. Instrumental Enrichment tools. b. life events analysis. c. Stories, lyrics and movie clips. d. Worksheets. The intervention encompasses 12 sessions of 1.5 hours, with a routine structure.\n\nThe results are expected to contribute to the understanding of the impact of a dynamic cognitive intervention in women diagnosed with borderline personality disorder."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women\n* Age 18 - 45\n* Borderline Personality Disorder, by DSM-V\n\nExclusion Criteria:\n\n* Current Acute Depressive Episode\n* Current Psychotic Episode\n* Less Than 12 school years\n* Non Compliance with therapy\n* Dual diagnosis'}, 'identificationModule': {'nctId': 'NCT01531634', 'briefTitle': 'Promoting Recovery Processes in Women With Borderline Personality Disorder Using a Dynamic Cognitive Intervention', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Promoting Recovery Processes in Women Diagnosed With Borderline Personality Disorder Using a Dynamic Cognitive Intervention', 'orgStudyIdInfo': {'id': '0010-12-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dynamic Cognitive Intervention Group', 'description': 'Twelve Meetings of Dynamic Cognitive Intervention.', 'interventionNames': ['Behavioral: Dynamic Cognitive Intervention Group']}, {'type': 'NO_INTERVENTION', 'label': 'No Additional Intervention'}], 'interventions': [{'name': 'Dynamic Cognitive Intervention Group', 'type': 'BEHAVIORAL', 'otherNames': ['DCI'], 'description': 'Twelve meetings of a Dynamic Cognitive Intervention group.', 'armGroupLabels': ['Dynamic Cognitive Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Netanya', 'country': 'Israel', 'contacts': [{'name': 'Orly Tsabar, B.O.T.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Day Center for Mentally Ill', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'centralContacts': [{'name': 'Orly Tsabar, B.O.T.', 'role': 'CONTACT', 'email': 'orly.tsabar@gmail.com', 'phone': '972-54-6852344'}], 'overallOfficials': [{'name': 'Orly Tsabar, B.O.T.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}}}}