NCT02957747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
4 months until next milestone

Results Posted

Study results publicly available

January 2, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

2.2 years

First QC Date

September 21, 2016

Results QC Date

December 12, 2019

Last Update Submit

December 7, 2020

Conditions

Stress Disorders, Post-TraumaticIntimate Partner ViolenceAlcohol-Related Disorders

Keywords

Women VeteransSexual Trauma

Outcome Measures

Primary Outcomes (2)

  • Change in Number of Health Risks

    Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)

    Two months

  • Change in Number of Health Risks

    Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)

    Four months

Secondary Outcomes (3)

  • Adapted Treatment Services Review

    2 month

  • Adapted Treatment Services Review

    4 month

  • The Client Satisfaction Questionnaire

    time zero (completed immediately after participant receives intervention session)

Other Outcomes (11)

  • Effectiveness in Obtaining Resources Scale

    2 month

  • Effectiveness in Obtaining Resources Scale

    4 month

  • Alcohol Use Disorder Identification Test (AUDIT)

    Four-months

  • +8 more other outcomes

Study Arms (2)

Safety and Health Experiences Program

EXPERIMENTAL

Participants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education.

Behavioral: SHE

Control

NO INTERVENTION

Participants randomized to this arm will receive referrals to VA and community resources

Interventions

SHEBEHAVIORAL

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.

Also known as: Safety and Health Experiences program
Safety and Health Experiences Program

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Texas Veterans Healthcare System

Temple, Texas, 76504, United States

Location

Central Texas Veterans Healthcare System

Waco, Texas, 76711, United States

Location

Related Publications (2)

  • O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

    PMID: 37795783DERIVED

  • Creech SK, Pulverman CS, Kahler CW, Orchowski LM, Shea MT, Wernette GT, Zlotnick C. Computerized Intervention in Primary Care for Women Veterans with Sexual Assault Histories and Psychosocial Health Risks: a Randomized Clinical Trial. J Gen Intern Med. 2022 Apr;37(5):1097-1107. doi: 10.1007/s11606-021-06851-0. Epub 2021 May 19.

    PMID: 34013470DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAlcohol-Related DisordersSexual Trauma

Interventions

Safety

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Accident PreventionAccidentsPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Dr. Suzannah Creech, Ph.D.
Organization
VISN 17 Center of Excellence for Research on Returning War Veterans
Suzannah.Creech@va.gov
254-297-3025

Study Officials

  • Caron Zlotnick, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

  • Suzannah Creech, PhD

    VHA VISN 17 COE

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

September 21, 2016

First Posted

November 8, 2016

Study Start

June 12, 2017

Primary Completion

August 30, 2019

Study Completion

May 1, 2020

Last Updated

January 5, 2021

Results First Posted

January 2, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

No IPD will be made available for sharing

Locations

US(2)