Stress DisorderNCT01652443
Relationships and Health in the OEF/OIF Veteran Population
An observational study of Stress Disorder and Marriage, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorder, Marriage, Suicidal Ideation
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: OEF/OIF Veterans receiving or eligible to receive care at the VA
Who may be able to join
- OEF/OIF Veteran (at least one OEF/OIF deployment)
- Currently receiving or eligible to receive health care services at DVAMC
- In a current, established relationship for a duration of at least one year
- Age of 18-50
Who cannot join
- Inability to provide informed consent.
- Inability to adequately respond to questions regarding the informed consent procedure.
- Do not meet the inclusion criteria listed above.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Colorado Healthcare System
Denver, Colorado, 80220
About this study
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.
Read the 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.
- Conditions
- Stress Disorder, Marriage, Suicidal Ideation
- Keywords
- OEF/OIF Veterans, Relationships
- Medical subject headings
- Stress Disorders, Traumatic, Suicidal Ideation
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship satisfaction
Four item relationship satisfaction survey
Measured: One study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisa M Betthauser, MBA, Principal investigator, VA VISN 19 MIRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652443
- Sponsor's protocol ID
- 11-0488
- Status last verified
- May 2017
- First submitted
- 28 Dec 2011
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships and Health in the OEF/OIF Veteran Population
- ClinicalTrials.gov ID
- NCT01652443
- Acronym / sponsor ID
- 11-0488
- Conditions
- Stress Disorder, Marriage, Suicidal Ideation
- Keywords
- OEF/OIF Veterans, Relationships
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- Apr 2011 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- OEF/OIF Veterans receiving or eligible to receive care at the VA
Key inclusion criteria (4 listed)
- OEF/OIF Veteran (at least one OEF/OIF deployment)
- Currently receiving or eligible to receive health care services at DVAMC
- In a current, established relationship for a duration of at least one year
- Age of 18-50
Key exclusion criteria (3 listed)
- Inability to provide informed consent.
- Inability to adequately respond to questions regarding the informed consent procedure.
- Do not meet the inclusion criteria listed above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship satisfaction
Time frame: One study visit
Four item relationship satisfaction survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- VA VISN 19 MIRECC websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Stress Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Betthauser, MBA principal investigator
VA VISN 19 MIRECC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorder and Marriage, run by VA Eastern Colorado Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship satisfaction (time frame: One study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.