Military Physical and Sexual TraumaDHRMSNCT01692067
Deployment Health in Regular Military Women
An observational study of Military Physical and Sexual Trauma and Combat Trauma, run by Iowa City Veterans Affairs Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to determine potential risk factors for physical and sexual assault in regular military women (as opposed to Reserve and National Guard). In addition, this study seeks to determine associations between service women's violence exposures and: current physical and mental health status (e.g. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Military Physical and Sexual Trauma, Combat Trauma, PTSD
- How many people
- 871 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Jan 2013
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Women and Men who have or are currently serving in the USA regular military.
Who may be able to join
- Focus Group:
- Men or women who have or are currently active duty regular military (RM) of OIF/OEF service eras (10/7/01- present)
- Interview phase:
- Women, who have or are currently serving active duty RM during OIF/OEF service eras
Who cannot join
- Focus Group:
- Disabilities that render incapable of hearing
- Comprehending
- Communicating in a group or inhibit travel to focus group
- Interview phase:
- Disabilities that render incapable of hearing
Show all 9Show fewer
- Comprehending
- Communicating independently with interviewers by telephone
- Not having telephone and unable to access a nearby VA or other possible resource to contact toll free number.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anne G. Sadler, Ph.D.; VAMC
Iowa City, Iowa, 52246
Iowa City VAMC
Iowa City, Iowa, 52246
About this study
Official title: Combat, Sexual Assault and Post-Traumatic Stress in OIF/OEF Military Women
The purpose of this study is to determine potential risk factors for physical and sexual assault in regular military women (as opposed to Reserve and National Guard). In addition, this study seeks to determine associations between service women's violence exposures and: current physical and mental health status (e.g. PTSD), and access to and use of DoD, DVA and civilian healthcare.
Read the detailed description
Background: The proposed study of Regular Military service women builds on and extends a funded VA HSR\&D grant currently investigating similar objectives in Reserves and National Guard (R/NG) service women. This proposed study addresses the radically changing DoD and DVA health care delivery needs of two priority populations: women exposed to combat, and women sexually assaulted during military. There is a limited understanding of the complex relationship between these traumatic exposures and women's health outcomes, such as post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI) and with their subsequent health service use or barriers to care.
Objectives: The objectives are: 1) To identify and describe organizational, situational, and individual risk factors for physical and sexual assault (i.e., victimization) in women who have served or are currently serving in the Regular Military in Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) by deployment status (those who are deployed to combat related regions once, those deployed more than once, those serving in non-combat related areas outside of the continental United States (US), or those serving within the continental US. 2) To determine associations between PTSD, TBI, and physical and sexual assault during OEF/OIF with current physical and mental health status and health risk behaviors by deployment status. 3) To identify current internal and external barriers to DoD, DVA, and civilian health services in relationship to women's deployment and victimization status and the association between PTSD and TBI; 4) To identify and describe differences between Regular Military and R/NG populations for each of these objectives.
Methods: We propose a cross sectional study design with two sequential phases. Phase 1 would include focus groups to refine the current study interview specific to Regular Military populations. Phase 2 would involve the identification and successful interviewing of 669 Regular Military service women, using random sampling with stratification by deployment status, state of service accession, and service branch. Building on our current study, women will be selected from five states: Iowa, Illinois, Kansas, Missouri, and Nebraska. Potential study participants will be mailed an information summary and asked to take part in a study assessing the deployment health of military women. 1058 women will be contacted to obtain the target of 669 completed interviews. Consenting participants (167 per deployment group) will complete a telephone interview that assesses socio-demographic variables, trauma exposures, health history, current health status, military environmental factors (organizational and situational factors), military and DVA health care and barriers to this care, and self reported service use. Descriptive analysis and multiple logistic regression analysis will be used.
Implications: It is unclear if the needs of military women are met by current combat-associated PTSD treatments originally based on male populations. It is anticipated that our findings will improve understanding of the health risks and outcomes of deployed Regular Military service women in contrast to women serving in the R/NG (with PTSD and TBI as key outcome variables). Our results consequently will have implications for DoD and DVA evidence based interventions for both primary prevention and care.
- Conditions
- Military Physical and Sexual Trauma, Combat Trauma, PTSD, TBI
- Keywords
- Rape, Women, Military, Veterans, Post-traumatic Stress Disorder, Traumatic Brain Injury
- Medical subject headings
- Sexual Trauma, Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| D0 | Not deployed | |
| D1 | Deployed to combat-related regions once | |
| D2 | Deployed to combat related regions more than once | |
| D3 | Deployed outside of the continental US but not to combat related regions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organizational, situational, and individual risk factors for physical and sexual assault in women who have or currently serving in active duty Regular Military in OIF/OEF by deployment status.
Measured: Months 28-42 of grant
Secondary outcomes (6)
Traumatic brain injury
Measured: Months 28-42 of grant
Current internal (e.g. PTSD) and external barriers (e.g. access to care factors)to health services
Measured: Months 28-42 of grant
Identification and description of differences between Regular Military and Reserve/National Guard service women for each of these aims (building on currently funded grant).
Measured: Months 28-42 of grant
PTSD
Measured: Months 28-42 of Grant
Current medical health, including reproductive health
Measured: Months 28-42 of grant
Deployment factors associated with risk of violence/health
Measured: Months 28-42 of grant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startApr 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Military Physical and Sexual TraumaStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa City Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense, US Department of Veterans Affairs
- Responsible party
- Principal investigator, Anne G SAdler, Iowa City Veterans Affairs Medical Center
- Investigators
- Anne G Sadler, Ph.D., Principal investigator, US Department of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692067
- Sponsor's protocol ID
- PT075819
- Other IDs
- GRANT00341283 (USAMRMC), DHI08-136 (DVA)
- Acronym
- DHRMS
- Status last verified
- Jul 2019
- First submitted
- 28 Jul 2011
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combat, Sexual Assault and Post-Traumatic Stress in OIF/OEF Military Women
- ClinicalTrials.gov ID
- NCT01692067
- Acronym / sponsor ID
- DHRMS / PT075819
- Conditions
- Military Physical and Sexual Trauma, Combat Trauma, PTSD, TBI
- Keywords
- Rape, Women, Military, Veterans, Post-traumatic Stress Disorder, Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 871 participants (actual)
- Lead sponsor
- Iowa City Veterans Affairs Medical CenterUS federal agency
- Collaborators
- United States Department of Defense, US Department of Veterans Affairs
- Study start
- Apr 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Sep 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 purpose of this study is to determine potential risk factors for physical and sexual assault in regular military women (as opposed to Reserve and National Guard). In addition, this study seeks to determine associations between service women's violence exposures and: current physical and mental health status (e.g. PTSD), and access to and use of DoD, DVA and civilian healthcare.
Detailed description
Background: The proposed study of Regular Military service women builds on and extends a funded VA HSR\&D grant currently investigating similar objectives in Reserves and National Guard (R/NG) service women. This proposed study addresses the radically changing DoD and DVA health care delivery needs of two priority populations: women exposed to combat, and women sexually assaulted during military. There is a limited understanding of the complex relationship between these traumatic exposures and women's health outcomes, such as post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI) and with their subsequent health service use or barriers to care.
Objectives: The objectives are: 1) To identify and describe organizational, situational, and individual risk factors for physical and sexual assault (i.e., victimization) in women who have served or are currently serving in the Regular Military in Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) by deployment status (those who are deployed to combat related regions once, those deployed more than once, those serving in non-combat related areas outside of the continental United States (US), or those serving within the continental US. 2) To determine associations between PTSD, TBI, and physical and sexual assault during OEF/OIF with current physical and mental health status and health risk behaviors by deployment status. 3) To identify current internal and external barriers to DoD, DVA, and civilian health services in relationship to women's deployment and victimization status and the association between PTSD and TBI; 4) To identify and describe differences between Regular Military and R/NG populations for each of these objectives.
Methods: We propose a cross sectional study design with two sequential phases. Phase 1 would include focus groups to refine the current study interview specific to Regular Military populations. Phase 2 would involve the identification and successful interviewing of 669 Regular Military service women, using random sampling with stratification by deployment status, state of service accession, and service branch. Building on our current study, women will be selected from five states: Iowa, Illinois, Kansas, Missouri, and Nebraska. Potential study participants will be mailed an information summary and asked to take part in a study assessing the deployment health of military women. 1058 women will be contacted to obtain the target of 669 completed interviews. Consenting participants (167 per deployment group) will complete a telephone interview that assesses socio-demographic variables, trauma exposures, health history, current health status, military environmental factors (organizational and situational factors), military and DVA health care and barriers to this care, and self reported service use. Descriptive analysis and multiple logistic regression analysis will be used.
Implications: It is unclear if the needs of military women are met by current combat-associated PTSD treatments originally based on male populations. It is anticipated that our findings will improve understanding of the health risks and outcomes of deployed Regular Military service women in contrast to women serving in the R/NG (with PTSD and TBI as key outcome variables). Our results consequently will have implications for DoD and DVA evidence based interventions for both primary prevention and care.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| D0 | – | –Not deployed |
| D1 | – | –Deployed to combat-related regions once |
| D2 | – | –Deployed to combat related regions more than once |
| D3 | – | –Deployed outside of the continental US but not to combat related regions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women and Men who have or are currently serving in the USA regular military.
Key inclusion criteria (4 listed)
- Focus Group:
- Interview phase:
Key exclusion criteria (9 listed)
- Focus Group:
- Interview phase:
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
Organizational, situational, and individual risk factors for physical and sexual assault in women who have or currently serving in active duty Regular Military in OIF/OEF by deployment status.
Time frame: Months 28-42 of grant
6 secondary outcomes
Traumatic brain injury
Time frame: Months 28-42 of grant
Current internal (e.g. PTSD) and external barriers (e.g. access to care factors)to health services
Time frame: Months 28-42 of grant
Identification and description of differences between Regular Military and Reserve/National Guard service women for each of these aims (building on currently funded grant).
Time frame: Months 28-42 of grant
PTSD
Time frame: Months 28-42 of Grant
Current medical health, including reproductive health
Time frame: Months 28-42 of grant
Deployment factors associated with risk of violence/health
Time frame: Months 28-42 of grant
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 19 Jul 2019.
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.
Anne G Sadler, Ph.D. principal investigator
US Department of Veterans Affairs
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Military Physical and Sexual Trauma and Combat Trauma, run by Iowa City Veterans Affairs Medical Center at 2 sites 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 9 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Organizational, situational, and individual risk factors for physical and sexual assault in women who have or currently serving in active duty Regular Military in OIF/OEF by deployment status. (time frame: Months 28-42 of grant). 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 19 Jul 2019.