Prolonged Grief and Suicide Among Veterans
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 22, 2010 | ||||||||
| Last Updated Date | April 11, 2011 | ||||||||
| Start Date ICMJE | November 2010 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Prolonged Grief Disorder- 13 [ Time Frame: At least six months post-bereavement ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01247025 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Adult Suicidal Ideation Questionnaire [ Time Frame: Within past month ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prolonged Grief and Suicide Among Veterans | ||||||||
| Official Title ICMJE | Examining Prolonged Grief Disorder and Its Relationship to Self-Directed Violence Among Veterans | ||||||||
| Brief Summary | The primary research question in this study will ask, among those receiving outpatient mental health services (MHS) at the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans Affairs Medical Center (VAMC), how many suffer from Prolonged Grief Disorder (PGD)? Here, it is hypothesized that PGD will occur within the sample. A secondary aim of this study will be to investigate how often PGD co-occurs with posttraumatic stress disorder (PTSD) and/or depression. Also, while PGD has been shown to have an effect on self-directed violence (SDV) among civilians (Prigerson, Bridge et al., 1999), no studies yet have examined the relationship between PGD and SDV among Veterans. Therefore, it also is hypothesized that as PGD severity increases among the Veteran sample, risk for SDV will increase as well. Additional research aims also will be addressed in this study. For one, it will be assessed which grief symptoms are most often reported among the Veteran sample. Also, no study has yet to examine if there are neuropsychological differences between PGD and PTSD. Therefore, another research question here is whether PGD indeed is neuropsychologically different from PTSD. Here, the exploratory hypothesis is that PGD sufferers will respond to a measure of multiple components of cognition (e.g., planning, sequencing, concentration, multitasking, and memory efficiency) in a manner that is significantly different from PTSD sufferers. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | The participants in this observational study will be all individuals willing and eligible among those seeking outpatient mental health services at the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans Affairs Medical Center (VAMC). It is expected that 180 participants will be enrolled in an effort to obtain up to 150 completed protocols. Women and minorities will be recruited as a routine part of the study. However, given the participant population within the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans Affairs Medical Center (VAMC), it is expected the majority of participants will be Caucasian men. |
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| Condition ICMJE |
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| Intervention ICMJE | Other: No intervention
This study will not contain a specific intervention |
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| Study Group/Cohort (s) | Veterans
Veterans receiving mental health services at the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans Affairs Medical Center (VAMC)
Intervention: Other: No intervention |
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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 | Enrolling by invitation | ||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||
| Estimated Completion Date | August 2011 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| 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 | NCT01247025 | ||||||||
| Other Study ID Numbers ICMJE | jrings1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jeffrey A. Rings/Postdoctoral Psychology Fellow, VA VISN 19 MIRECC | ||||||||
| Study Sponsor ICMJE | VA Eastern Colorado Health Care System | ||||||||
| Collaborators ICMJE | University of Colorado, Denver | ||||||||
| Investigators ICMJE |
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| Information Provided By | VA Eastern Colorado Health Care System | ||||||||
| Verification Date | April 2011 | ||||||||
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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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