Stress Disorders, Post-TraumaticSHENCT02957747
Addressing the Health Concerns of VA Women With Sexual Trauma
A study testing SHE in people with Stress Disorders, Post-Traumatic and Intimate Partner Violence, run by VISN 17 Center of Excellence at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Intimate Partner Violence, Alcohol-Related Disorders
- What is being tested?
- SHE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jun 2017to 1 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Texas Veterans Healthcare System
Temple, Texas, 76504
Central Texas Veterans Healthcare System
Waco, Texas, 76711
About this study
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.
Read the 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:
- Develop the preliminary computer-based intervention, incorporating information gained in informant interviews.
- Perform a small open trial (n = 20) of SHE to assess feasibility of recruitment of target population and acceptability of intervention and study procedures.
- 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.
- 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.
- Being tested
- SHE
- Keywords
- Women Veterans, Sexual Trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcohol-Related Disorders, Sexual Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHEBehavioural
Also called Safety and Health Experiences program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SHE |
| Control | No intervention | Participants randomized to this arm will receive referrals to VA and community resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Health Risks
Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)
Measured: 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)
Measured: Four months
Secondary outcomes (3)
Adapted Treatment Services Review
Self-report and chart review of utilization of mental health and substance abuse treatment. Range is open, as measure assesses women's self-report of treatment appointments. Higher scores indicate a greater number of treatment appointments and thus greater use of treatment (i.e., better outcome).
Measured: 2 month
Adapted Treatment Services Review
Self-report and chart review of utilization of mental health and substance abuse treatment. Range is open, as measure assesses women's self-report of treatment appointments. Higher scores indicate a greater number of treatment appointments and thus greater use of treatment (i.e., better outcome).
Measured: 4 month
The Client Satisfaction Questionnaire
8-item questionnaire which assesses the participant's satisfaction with the intervention. Score range 4-32; higher scores indicate higher satisfaction with the intervention (i.e., better outcome).
Measured: time zero (completed immediately after participant receives intervention session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start12 Jun 2017
- Primary completion30 Aug 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- VISN 17 Center of Excellence
- Sponsor type
- US federal agency
- Collaborators
- Brown University, Women and Infants Hospital of Rhode Island
- Responsible party
- Principal investigator, Suzannah Creech, VISN 17 Center of Excellence
- Investigators
- Caron Zlotnick, PhD, Principal investigator, Brown UniversitySuzannah Creech, PhD, Principal investigator, VHA VISN 17 COE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957747
- Sponsor's protocol ID
- 00614
- Acronym
- SHE
- Status last verified
- Dec 2020
- First submitted
- 21 Sep 2016
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be made available for sharing
Publications
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.
PubMed 37795783Creech 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.
PubMed 34013470
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing the Health Concerns of VA Women With Sexual Trauma
- ClinicalTrials.gov ID
- NCT02957747
- Acronym / sponsor ID
- SHE / 00614
- Keywords
- Women Veterans, Sexual Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- VISN 17 Center of ExcellenceUS federal agency
- Collaborators
- Brown University, Women and Infants Hospital of Rhode Island
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Posted 2 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Develop the preliminary computer-based intervention, incorporating information gained in informant interviews.
- Perform a small open trial (n = 20) of SHE to assess feasibility of recruitment of target population and acceptability of intervention and study procedures.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety and Health Experiences Program | Experimental | Behavioral: SHEParticipants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education. |
| Control | No intervention | –Participants randomized to this arm will receive referrals to VA and community resources |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHEAlso: Safety and Health Experiences programSHE 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. | Behavioural | Safety and Health Experiences Program |
Primary outcome
Change in Number of Health Risks
Time frame: Two months
Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)
Change in Number of Health Risks
Time frame: Four months
Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)
3 secondary outcomes
Adapted Treatment Services Review
Time frame: 2 month
Adapted Treatment Services Review
Time frame: 4 month
The Client Satisfaction Questionnaire
Time frame: time zero (completed immediately after participant receives intervention session)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37795783O'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.
- Derived from this study: PubMed 34013470Creech 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.
- Individual participant dataSharing planned: No. No IPD will be made available for sharing
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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.
Caron Zlotnick, PhD principal investigator
Brown University
Suzannah Creech, PhD principal investigator
VHA VISN 17 COE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHE in people with Stress Disorders, Post-Traumatic and Intimate Partner Violence, run by VISN 17 Center of Excellence 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 6 inclusion and 0 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 5 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Number of Health Risks (time frame: Two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02957747, which also lists 2 linked publications.
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 5 Jan 2021.