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Trial record 17 of 99 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Texas, United States ) | NIH, U.S. Fed

Addressing the Health Concerns of VA Women With Sexual Trauma (SHE)

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ClinicalTrials.gov Identifier: NCT02957747
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
Brown University
Women and Infants Hospital of Rhode Island
Information provided by (Responsible Party):
Suzannah Creech, VISN 17 Center of Excellence

Tracking Information
First Submitted Date  ICMJE September 21, 2016
First Posted Date  ICMJE November 8, 2016
Last Update Posted Date April 25, 2019
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • 30-day Alcohol Timeline Follow back [ Time Frame: 2 month follow up ]
    calendar-assisted measure used to garner a retrospective account of drinking behavior
  • Composite Abuse Scale [ Time Frame: 2 month follow up ]
    30 items measure of chronicity and occurrence of intimate partner violence with current partner
  • Trauma History Screen [ Time Frame: 2 month follow up ]
    13-item self-report measure that examines 11 traumatic events and one general event, including military trauma, sexual assault and natural disasters
  • PCL-5 [ Time Frame: 2 month follow up ]
    Symptoms of PTSD
  • 30-day Alcohol Timeline Follow back [ Time Frame: 4 month follow-up ]
    calendar-assisted measure used to garner a retrospective account of drinking behavior
  • Composite Abuse Scale [ Time Frame: 4 month follow-up ]
    30 items measure of chronicity and occurrence of intimate partner violence with current partner
  • Trauma History Screen [ Time Frame: 4 month follow-up ]
    13-item self-report measure that examines 11 traumatic events and one general event, including military trauma, sexual assault and natural disasters
  • PCL-5 [ Time Frame: 4 month follow-up ]
    Symptoms of PTSD
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02957747 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • Effectiveness in Obtaining Resources Scale [ Time Frame: 2 month and 4 month follow-up ]
    assesses women's effectiveness in obtaining resources from 11 different types of community resources including church or clergy, health care, legal services, police, or social services
  • adapted Treatment Services Review [ Time Frame: 2 month and 4 month follow-up ]
    Utilization of treatment
  • Quality of Marriage Index [ Time Frame: 2 month and 4 month follow up ]
    6 item measure of relationship distress
  • Family Assessment Device 12 [ Time Frame: 2 month and 4 month follow up ]
    brief measure of general family functioning
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 3, 2016)
  • Satisfaction with CIAS Software Scale [ Time Frame: time zero (completed immediately after participant receives intervention session) ]
    assesses participant satisfaction on items tapping on likeability, ease of use, level of interest, and respectfulness using a 1 - 5 Likert scale (1 = low, and 5 = high)
  • The Client Satisfaction Questionnaire [ Time Frame: time zero (completed immediately after participant receives intervention session) ]
    8-item questionnaire which assesses the participant's satisfaction with the intervention
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Addressing the Health Concerns of VA Women With Sexual Trauma
Official Title  ICMJE Addressing the Health Concerns of VA Women With Sexual Trauma
Brief Summary

Lifetime sexual trauma (ST) (i.e., behaviors that range from unwanted sexual touching to attempted or completed rape) is a significant social and public health problem among women Veterans. For women Veterans, lifetime ST can occur prior to, during or after military service. ST is associated with multiple difficulties and risks, including posttraumatic stress disorder (PTSD), intimate partner violence (IPV), and alcohol misuse. Providing an effective, integrated, and low-cost intervention that targets ST-related risks for women Veterans with lifetime ST would advance clinical care for these vulnerable women.

This research will develop and assess a computer-delivered intervention (Safety and Health Experiences Program; SHE) that will provide a screening and brief behavior intervention for women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD). SHE will be designed to provide individualized assessment, feedback, and referrals for women Veterans with any lifetime ST. SHE will take place within a primary care setting. Primary care visits are frequent points of health care contact for women Veterans making the visit itself the ideal, and possibly only, opportunity to provide behavioral interventions.

This study will lay the groundwork for a larger clinical trial of the SHE program in multiple VA primary care settings. If effective, the intervention, SHE, represents an innovative and low cost service for early identification and intervention that could be implemented nationwide with ease and speed to address the needs of women Veterans with lifetime ST. The long-term goal of the project is to make a significant impact on advancing health services research by introducing and testing a novel and potentially powerful service tool that may improve service delivery to address the co-occurring health concerns for women Veterans with any lifetime ST.

Detailed Description

The VA Women's Health Research Agenda underscores the importance of improving the safety and health outcomes of returning Veteran women. With greater numbers of women joining the military, the need for gender-specific VA-based interventions is increasingly important. Posttraumatic stress disorder (PTSD), intimate partner violence (IPV), and alcohol use are closely interrelated and significant concerns for women Veterans with a history of sexual trauma (ST). Given that screening for military sexual trauma (MST) is mandated within VAs, a computer delivered intervention has the potential to be easily integrated into the standard of care for women who screen positive for MST and/or other lifetime STs, increasing the identification of high-risk women Veterans. This intervention will provide a computer-based intervention on a VA issued laptop that could improve delivery service and fill a healthcare gap for a vulnerable Veteran population.

The long-term goal of the project is to make a significant impact on advancing health services research by introducing and testing a novel and potentially powerful service tool that may improve service delivery to address the co-occurring health concerns for VA women with lifetime ST. The intervention, Safe and Healthy Experiences (SHE), a brief modular, computer-based intervention, will target interrelated health risks for women Veterans with lifetime ST (i.e. alcohol misuse, IPV, and PTSD). SHE will provide individualized assessment, feedback, and referrals for women Veterans with lifetime ST. The intervention is based on motivational interviewing (MI), a well-defined intervention strategy that has yielded particularly promising results in a range of clinical issues, including interpersonal violence, and a range of patient populations, including male and female Veterans. MI is a collaborative and non-confrontational approach that emphasizes increasing a participant's awareness of successful steps towards well-being. MI is consistent with an empowerment model, which is a highly recommended intervention model for victimized women and both MI and an empowerment model converge on important principles for intervening with victimized women.

Findings from the study will provide the necessary groundwork to examine the efficacy of SHE in a future, large clinical trial. If the SHE intervention is found to be feasible, acceptable and efficacious in improving outcomes for women Veterans with lifetime ST, the ultimate goal would be for the program to be integrated into clinical care and widely disseminated. There are two phases of research directed toward these aims: 1) develop and refine an integrated screening and behavior intervention for VA women with lifetime ST in a brief modular computer-based format that can be administered in a VA primary care setting, and 2) collect data on the feasibility, acceptability, and initial efficacy of the intervention in improving the health of VA women, and increasing utilization of treatment and resources.

The study aims are to:

  1. Develop the preliminary computer-based intervention, incorporating information gained in informant interviews.
  2. Perform a small open trial (n = 20) of SHE to assess feasibility of recruitment of target population and acceptability of intervention and study procedures.
  3. Conduct an initial randomized control trial in a sample of 150 women Veterans who screen positive for lifetime sexual trauma (ST) and have at least one risk factor (i.e., screen positive for intimate partner violence (IPV), posttraumatic stress disorder (PTSD), and/or heavy drinking) to demonstrate the feasibility of SHE and the acceptability of SHE via participant report of ease of use, helpfulness, and overall satisfaction.
  4. Examine preliminary evidence for the hypotheses that, relative to the control condition, screening and referral only (SR), SHE will result in:

    • Decreases in the number of risks (i.e., heavy drinking (4+ drinks on one occasion), screen positive for PTSD, screen positive for IPV) at the 2- and 4-month follow-up (primary).
    • Increases in resource and treatment utilization over the 2- and 4-month follow-up period (secondary).

The data will be used to demonstrate whether the effects of the intervention look promising to support a future large-scale randomized control trial and to suggest, in concert with results from clinical trials in related fields, the range of effect sizes that would be reasonable to expect in a future trial.

This is a multi-site study. At the Providence, RI based site (Women and Infants Hospital and Brown University), the specialized computer-based assessment and interactive intervention sessions will be developed and designed and staff members will also assist with data management. The Central Texas VA Healthcare System site will be the data collection site and the main site for participant recruiting, consenting, enrollment, intervention and follow-up. Staff at the two sites will work collaboratively throughout the project to supervise study staff, for reporting to the DOD and IRB's and in designing the assessment and intervention sessions, however, only the study staff at the Central Texas site will have access to participant PHI.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stress Disorders, Post-Traumatic
  • Intimate Partner Violence
  • Alcohol-Related Disorders
Intervention  ICMJE Behavioral: SHE
SHE is a computer-delivered intervention (Safety and Health Experiences Program; SHE) that will provide a screening and brief behavior intervention for women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD). SHE will provide individualized assessment, feedback, and referrals for women Veterans with any lifetime ST. SHE will take place within a primary care setting.
Other Name: Safety and Health Experiences program
Study Arms  ICMJE
  • Experimental: Safety and Health Experiences Program
    Participants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education.
    Intervention: Behavioral: SHE
  • No Intervention: Control
    Participants randomized to this arm will receive referrals to VA and community resources
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
 (submitted: November 3, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Female Veterans

  • Lifetime history of ST with at least one risk factor: heavy drinking within the past 3 months, screen positive for current PTSD or for IPV within last 12 months
  • Age 18-65
  • Seeking treatment through the Women's Primary Care Clinics at the Central Texas VA Healthcare System.
  • Ability to understand study procedures in English
  • Not actively in suicidal or homicidal crisis warranting imminent hospitalization
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mollie E Shin, BA 254-297-3027 Mollie.Shin@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02957747
Other Study ID Numbers  ICMJE 00614
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD will be made available for sharing
Responsible Party Suzannah Creech, VISN 17 Center of Excellence
Study Sponsor  ICMJE VISN 17 Center of Excellence
Collaborators  ICMJE
  • Brown University
  • Women and Infants Hospital of Rhode Island
Investigators  ICMJE
Principal Investigator: Caron Zlotnick, PhD Brown University
Principal Investigator: Suzannah Creech, PhD VHA VISN 17 COE
PRS Account VISN 17 Center of Excellence
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP