Internet-Based Intervention to Improve Mental Health Outcomes for Abused Women
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| First Received Date ICMJE | March 9, 2011 | ||||
| Last Updated Date | May 7, 2013 | ||||
| Start Date ICMJE | March 2011 | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT01312103 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Internet-Based Intervention to Improve Mental Health Outcomes for Abused Women | ||||
| Official Title ICMJE | Internet-Based Intervention to Improve Mental Health Outcomes for Abused Women | ||||
| Brief Summary | The purpose for this trial is to test the effectiveness of the first interactive internet-based safety decision aid on abused women's exposure to repeat intimate partner violence (IPV) and mental health outcomes. An improved safety decision-making process (e.g., knowing the advantages and disadvantages of the relationship, having enough information to make a decision) will increase safety-seeking behaviors which in turn will decrease exposure to repeat IPV and improve mental health outcomes. Findings from the development and initial test of our computerized safety decision aid suggests that it offered abused women privacy to consider personalized safety options, informed them about danger in their relationship and would be used again if they had access to it through a safe internet site. The investigators are conducting a five year experimental trial in four states (Oregon, Maryland, Missouri, and Arizona) to address the following aims:
This study will provide much needed new information about safety planning's impact on making difficult safety decisions, exposure to violence, and mental health effects. |
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| Detailed Description | Intimate partner violence (IPV) is well established as a widespread problem with important negative physical and mental health, social and cost consequences for victims, their families and the community. Beyond the physical conditions associated with IPV, research has consistently demonstrated a strong association between experiencing IPV and increased rates of anxiety, depression, low-self esteem, substance abuse and suicidality. Increasing abused women's safety and reducing ongoing exposure to violence is key to minimizing such consequences. Building from the empowerment framework, safety planning interventions focus on protecting women from exposure to repeat violence. However, despite the significant evidence of the negative outcomes of IPV and the complex individual and community factors that influence safety, little is known about what interventions improve the safety and mental health outcomes of abused women. While experimental trials are beginning, to date there has not been a trial to examine the effectiveness of safety planning, a cornerstone of IPV interventions, on exposure to repeat violence, safety, and mental health outcomes for women. An internet-based safety decision aid may assist abused women in weighing risks and benefits of safety options, assessing danger, and identifying the factors that are most important in their safety decisions. Further, it provides personalized links with community mental health and domestic violence resources, which are invaluable in assisting women in planning for safety, thereby reducing the immediate and long terms risk of negative mental health consequences of violence. Women who consent to participate in this study and who have access to a safe computer (e.g. at home, work, community agency, friend/family) will be randomized to the intervention or control group. If a woman is randomized into the intervention group, she will complete the internet-based safety decision aid program. The decision aid program will be located on a confidential password protected and secured study website and will take approximately 60 minutes to complete. Participants will first be asked demographic and relationship questions as well as questions about their ability to make decisions about safety in their relationship. Next, participants will be asked to make a series of comparisons to determine the importance of specific factors such as: keeping the abuse private, safety of self, family and children, feelings for partner, resources such as housing and employment and maintaining norms within family, to safety decisions. Participants will then be asked questions specific to risk factors for violence and safety seeking behaviors in their relationship. After completion, the safety decision aid generates results to provide an individualized safety plan to the participant. Women randomized into the control group will access the confidential and password protected control website which includes a brief assessment of risk factors and their history of violence, and will provide a list of local resources, but not an individualized safety plan. Both intervention and control group participants will then complete a series of instruments to measure intimate partner violence, mental health outcomes, and safety seeking behaviors. Each participant will have a skilled and trained research assistant available by phone or email to assist them in understanding questions, interpreting the results, developing strategies for safety and providing referrals for community-based services. Follow up sessions on the study website will be conducted at 3, 6, and 12 months post-baseline. Participants will be encouraged by the RA through phone or email contact to access the password-protected website to complete the internet session and follow-up assessment questions. Post-baseline questions will be the same as the baseline, but will focus on outcomes since the previous internet session. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
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| Condition ICMJE | Domestic Violence | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Glass N, Eden KB, Bloom T, Perrin N. Computerized aid improves safety decision process for survivors of intimate partner violence. J Interpers Violence. 2010 Nov;25(11):1947-64. Epub 2009 Dec 29. | ||||
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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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 720 | ||||
| Estimated Completion Date | February 2015 | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 64 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01312103 | ||||
| Other Study ID Numbers ICMJE | 1R01MH085641, R01MH085641 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Nancy Glass, Johns Hopkins University | ||||
| Study Sponsor ICMJE | Johns Hopkins University | ||||
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| Investigators ICMJE |
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| Information Provided By | Johns Hopkins University | ||||
| Verification Date | May 2013 | ||||
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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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