Clinical trial NCT01692067: Deployment Health in Regular Military Women
Official title: Combat, Sexual Assault and Post-Traumatic Stress in OIF/OEF Military Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Military Physical and Sexual Trauma
Combat Trauma
PTSD
TBI
Keywords: Rape
Women
Military
Veterans
Post-traumatic Stress Disorder
Traumatic Brain Injury
Lead sponsor: Iowa City Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: United States Department of Defense
name: US Department of Veterans Affairs
First posted: 2012-09-25
Enrollment: 871
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women and Men who have or are currently serving in the USA regular military.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
  * 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.

Primary outcomes:
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.
timeFrame: Months 28-42 of grant
Secondary outcomes:
measure: Traumatic brain injury
timeFrame: Months 28-42 of grant
measure: Current internal (e.g. PTSD) and external barriers (e.g. access to care factors)to health services
timeFrame: Months 28-42 of grant
measure: Identification and description of differences between Regular Military and Reserve/National Guard service women for each of these aims (building on currently funded grant).
timeFrame: Months 28-42 of grant
measure: PTSD
timeFrame: Months 28-42 of Grant
measure: Current medical health, including reproductive health
timeFrame: Months 28-42 of grant
measure: Deployment factors associated with risk of violence/health
timeFrame: Months 28-42 of grant
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Anne G. Sadler, Ph.D.; VAMC
state: Iowa
city: Iowa City
country: United States
facility: Iowa City VAMC
state: Iowa
Study officials:
affiliation: US Department of Veterans Affairs
name: Anne G Sadler, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: