Violence Against Women and Consequences During Climacteric´s Phase (DV)
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 7, 2009 | ||||||||
| Last Updated Date | April 7, 2010 | ||||||||
| Start Date ICMJE | April 2009 | ||||||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Women subjected to sexual violence had significative higher incidence of depression and fibromyalgia that did not respond to classic treatment; after two sessions of Cognitive Behavioral Therapy started to respond to medicine previously employed. [ Time Frame: 8 months ] [ Designated as safety issue: Yes ] | ||||||||
| Change History | Complete list of historical versions of study NCT01028118 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Sessions of Cognitive Behavioral Therapy is good for women subject to sexual violence. [ Time Frame: 8 months ] [ Designated as safety issue: Yes ] Women subjected to violence in any phase of their lives had at least three chronic comorbidities. The correlation between having been subjected to violence and suffering from depression, fibromyalgia or sexual dysfunctions (statistical significant). |
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| Original Secondary Outcome Measures ICMJE |
Women subjected to violence in any phase of their lives had at least three chronic comorbidities. The correlation between having been subjected to violence and suffering from depression, fibromyalgia or sexual dysfunctions (statistical significant). [ Time Frame: 8 months ] [ Designated as safety issue: Yes ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Violence Against Women and Consequences During Climacteric´s Phase | ||||||||
| Official Title ICMJE | Domestic and Sexual Violence Against Women: Consequences for Climacteric´s Phase | ||||||||
| Brief Summary | Objective- Analysis of the health status of women who were or are victims of domestic and sexual violence seeking attention at the outpatient clinic for Endocrines Gynecology and Climactery - University of Sao Paulo General Hospital. To widen the comprehension of the binomial relationship violence-pathologies by professionals/staff who work in health services, offering women in such situation humane, comprehensive and qualified attention. Specific Objectives: decreasing the rates of domestic and sexual violence against women employing: prevention, health education and treatment - within the context of health services and public policies. Methodology - Project Type: Research in Action A- Attention to women in a situation of domestic and sexual violence during climactery; B- Information/Education/Communication (IEC) C- Behavioral Intervention (IC) D- Institutional Development (DI). Target Populations: 1. Women (during the ages of 40 to 65 years) who were or are victims of domestic and/or sexual violence; 2. Professional/staff who work in services attending women in sexual and domestic violent situations (health professionals, policemen, civil society) in areas located within the South Regional Health Coordination - SRC. To collect information, a semi structured questionnaire will be employed during seven months in 2009. |
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| Detailed Description | Trained professionals will work in the regions of: Campo Limpo, M'Boi Mirim, Santo Amaro and neighboring regions, neighborhood in which the Social Vulnerability Index of São Paulo (IPVS) shows high records. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Identifying experience with violence
Asking about life experience with violence and Cognitive Behavior Therapy.
Other Names:
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| Study Arm (s) | Therapy for Women reporting violence
Asking about life experience with violence and Cognitive Behavior Therapy.
Intervention: Other: Identifying experience with violence |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 300 | ||||||||
| Completion Date | October 2009 | ||||||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 40 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01028118 | ||||||||
| Other Study ID Numbers ICMJE | 180/09 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Edmund Chada Baracat, University of Sao Paulo General Hospital | ||||||||
| Study Sponsor ICMJE | University of Sao Paulo General Hospital | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Sao Paulo General Hospital | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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