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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

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.


Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Intimate Partner Violence Alcohol-Related Disorders Behavioral: SHE Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Addressing the Health Concerns of VA Women With Sexual Trauma
Study Start Date : August 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

No Intervention: Control
Participants randomized to this arm will receive referrals to VA and community resources



Primary Outcome Measures :
  1. 30-day Alcohol Timeline Follow back [ Time Frame: 2 month follow up ]
    calendar-assisted measure used to garner a retrospective account of drinking behavior

  2. Composite Abuse Scale [ Time Frame: 2 month follow up ]
    30 items measure of chronicity and occurrence of intimate partner violence with current partner

  3. 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

  4. PCL-5 [ Time Frame: 2 month follow up ]
    Symptoms of PTSD

  5. 30-day Alcohol Timeline Follow back [ Time Frame: 4 month follow-up ]
    calendar-assisted measure used to garner a retrospective account of drinking behavior

  6. Composite Abuse Scale [ Time Frame: 4 month follow-up ]
    30 items measure of chronicity and occurrence of intimate partner violence with current partner

  7. 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

  8. PCL-5 [ Time Frame: 4 month follow-up ]
    Symptoms of PTSD


Secondary Outcome Measures :
  1. 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

  2. adapted Treatment Services Review [ Time Frame: 2 month and 4 month follow-up ]
    Utilization of treatment

  3. Quality of Marriage Index [ Time Frame: 2 month and 4 month follow up ]
    6 item measure of relationship distress

  4. Family Assessment Device 12 [ Time Frame: 2 month and 4 month follow up ]
    brief measure of general family functioning


Other Outcome Measures:
  1. 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)

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957747


Contacts
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Contact: Mollie E Shin, BA 254-297-3027 Mollie.Shin@va.gov

Locations
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United States, Texas
Central Texas Veterans Healthcare System Recruiting
Temple, Texas, United States, 76504
Contact: Mollie Shin    254-297-3027    Mollie.Shin@va.gov   
Central Texas Veterans Healthcare System Recruiting
Waco, Texas, United States, 76711
Contact: Mollie Shin    254-297-3027    Mollie.Shin@va.gov   
Sponsors and Collaborators
VISN 17 Center of Excellence
Brown University
Women and Infants Hospital of Rhode Island
Investigators
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Principal Investigator: Caron Zlotnick, PhD Brown University
Principal Investigator: Suzannah Creech, PhD VHA VISN 17 COE

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Responsible Party: Suzannah Creech, Psychologist, VISN 17 Center of Excellence
ClinicalTrials.gov Identifier: NCT02957747     History of Changes
Other Study ID Numbers: 00614
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be made available for sharing
Keywords provided by Suzannah Creech, VISN 17 Center of Excellence:
Women Veterans
Sexual Trauma
Additional relevant MeSH terms:
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Disease
Alcohol-Related Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders