Relationships and Health in the OEF/OIF Veteran Population
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | December 28, 2011 | ||||||||
| Last Updated Date | July 25, 2012 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Relationship satisfaction [ Time Frame: One study visit ] [ Designated as safety issue: No ] Four item relationship satisfaction survey |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01652443 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Relationships and Health in the OEF/OIF Veteran Population | ||||||||
| Official Title ICMJE | Relationships and Health in the OEF/OIF Veteran Population | ||||||||
| Brief Summary | The current study will explore relationships and health in the OEF/OIF Veteran population. Specifically, this study will examine PTSD symptom severity, traumatic brain injury, relationship satisfaction, leisure, general health ratings, feelings of burdensomeness and belongingness, and suicidal ideation. |
||||||||
| Detailed Description | United States military troops returning home from Operation Enduring Freedom and Operation Iraqi Freedom deployments are presenting with "invisible wounds". These "invisible wounds" include mental health conditions such as posttraumatic stress disorder and traumatic brain injury. Recent literature has begun to explore how PTSD affects the service member, as well as their significant others. Several studies have shown that Veteran endorsement of PTSD symptoms is associated with decreased relationship satisfaction. Prior literature has shown that spending time together and engaging in pleasurable activities as a couple are important strategies for enduring relationship quality and satisfaction. Literature has demonstrated moderate relationships between PTSD and suicidal ideation. A previous study conducted by two of the investigators in this population showed that perceived feelings of burdensomeness and belongingness and identification of suicide as a potential strategy for dealing with these feelings. Joiner has hypothesized that acquired capacity of painful experiences, perceived burdensomeness and thwarted belongingness are the three components of increased suicide risk. Yet few studies exist that examine these constructs in the military population, though research indicates the clinical utility for exploring these constructs and related consequences. |
||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | OEF/OIF Veterans receiving or eligible to receive care at the VA |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 65 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01652443 | ||||||||
| Other Study ID Numbers ICMJE | 11-0488 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | VA Eastern Colorado Health Care System | ||||||||
| Study Sponsor ICMJE | VA Eastern Colorado Health Care System | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | VA Eastern Colorado Health Care System | ||||||||
| Verification Date | July 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||