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| Name | Class |
|---|---|
| Brown University | OTHER |
| Women and Infants Hospital of Rhode Island | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Participants randomized to this arm will receive referrals to VA and community resources |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHE | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 month |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness in Obtaining Resources Scale | 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. Reporting the subscale for "Things I have been successful at." Score range 0-13; higher scores indicate obtaining more resources (i.e., better outcome). | 2 month |
Inclusion Criteria:
Female Veterans
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| Name | Affiliation | Role |
|---|---|---|
| Caron Zlotnick, PhD | Brown University | Principal Investigator |
| Suzannah Creech, PhD | VHA VISN 17 COE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Texas Veterans Healthcare System | Temple | Texas | 76504 | United States | ||
| Central Texas Veterans Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37795783 | Derived | 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. | |
| 34013470 | Derived | 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. |
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No IPD will be made available for sharing
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| ID | Title | Description |
|---|---|---|
| FG000 | Safety and Health Experiences Program | Participants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education. 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. |
| FG001 | Control | Participants randomized to this arm will receive referrals to VA and community resources |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety and Health Experiences Program | Participants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Number of Health Risks | Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes) | intent to treat sample | Posted | Mean | Standard Deviation | number of risks | Two months |
|
Adverse event data was collected at 2-month and 4-month follow-up assessments. Timeline of events reported ranges from baseline to 4-month follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety and Health Experiences Program | Participants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization-Vertigo | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling unsafe at home-heard gunshots in neighborhood | Social circumstances | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suzannah Creech, Ph.D. | VISN 17 Center of Excellence for Research on Returning War Veterans | 254-297-3025 | Suzannah.Creech@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2018 | Nov 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D019973 | Alcohol-Related Disorders |
| D000082002 | Sexual Trauma |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| D012449 | Safety |
| ID | Term |
|---|---|
| D000056 | Accident Prevention |
| D000059 | Accidents |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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|
|
| 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). |
| 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). | time zero (completed immediately after participant receives intervention session) |
| Effectiveness in Obtaining Resources Scale | 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. Reporting the subscale for "Things I have been successful at." Score range 0-13; higher scores indicate obtaining more resources (i.e., better outcome). | 4 month |
| Alcohol Use Disorder Identification Test (AUDIT) | The AUDIT is a 10-item assessment for alcohol use problems, alcohol dependence and problem drinking. Participants respond to each item along 5-point scale ranging from 0 to 4, whereby higher scores reflect more severe alcohol use patterns. Responses are summed to reflect a total score ranging from 0 to 40, with higher scores reflecting higher severity of an individual's use of alcohol. | Four-months |
| Alcohol Use Disorder Identification Test (AUDIT) | The AUDIT is a 10-item assessment for alcohol use problems, alcohol dependence and problem drinking. Participants respond to each item along 5-point scale ranging from 0 to 4, whereby higher scores reflect more severe alcohol use patterns. Responses are summed to reflect a total score ranging from 0 to 40, with higher scores reflecting higher severity of an individual's use of alcohol. | Two-months |
| Composite Abuse Scale | 30 item measure of chronicity and occurrence of intimate partner violence with current partner in past 12 months. Score range from 0-150; higher scores indicate more intimate partner violence (i.e., worse outcome). | 2 month follow up |
| PCL-5 | Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome). | 4 month follow-up |
| Composite Abuse Scale | 30 item measure of chronicity and occurrence of intimate partner violence with current partner in past 12 months. Score range from 0-150; higher scores indicate more intimate partner violence (i.e., worse outcome). | 4 month follow-up |
| PCL-5 | Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome). | 2 month follow up |
| 30-day Alcohol Timeline Follow Back | Calendar-assisted measure used to garner a retrospective account of drinking behavior. Scale is in standard alcoholic drinks in an average week in the past month. Higher numbers indicate more drinks per week (i.e., worse outcome). | 4 month follow-up |
| 30-day Alcohol Timeline Follow Back | Calendar-assisted measure used to garner a retrospective account of drinking behavior. Scale is in standard alcoholic drinks in an average week in the past month. Higher numbers indicate more drinks per week (i.e., worse outcome). | 2 month follow up |
| Satisfaction With CIAS Software Scale | Assesses participant satisfaction with the computerized software with items on likeability, ease of use, level of interest, and respectfulness. Score range is 7-35; higher numbers indicate higher satisfaction with the software (i.e., better outcome). | time zero (completed immediately after participant receives intervention session) |
| Waco |
| Texas |
| 76711 |
| United States |
| BG001 | Control | Participants randomized to this arm will receive referrals to VA and community resources |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Participants randomized to this arm will receive referrals to VA and community resources |
|
|
| Primary | Change in Number of Health Risks | Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes) | intent to treat sample | Posted | Mean | Standard Deviation | number of risks | Four months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 2 month |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 4 month |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | time zero (completed immediately after participant receives intervention session) |
|
|
|
| Other Pre-specified | Effectiveness in Obtaining Resources Scale | 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. Reporting the subscale for "Things I have been successful at." Score range 0-13; higher scores indicate obtaining more resources (i.e., better outcome). | Posted | Mean | Standard Deviation | score on a scale | 2 month |
|
|
|
| Other Pre-specified | Effectiveness in Obtaining Resources Scale | 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. Reporting the subscale for "Things I have been successful at." Score range 0-13; higher scores indicate obtaining more resources (i.e., better outcome). | Posted | Mean | Standard Deviation | score on a scale | 4 month |
|
|
|
| Other Pre-specified | Alcohol Use Disorder Identification Test (AUDIT) | The AUDIT is a 10-item assessment for alcohol use problems, alcohol dependence and problem drinking. Participants respond to each item along 5-point scale ranging from 0 to 4, whereby higher scores reflect more severe alcohol use patterns. Responses are summed to reflect a total score ranging from 0 to 40, with higher scores reflecting higher severity of an individual's use of alcohol. | Posted | Mean | Standard Deviation | score on a scale | Four-months |
|
|
|
| Other Pre-specified | Alcohol Use Disorder Identification Test (AUDIT) | The AUDIT is a 10-item assessment for alcohol use problems, alcohol dependence and problem drinking. Participants respond to each item along 5-point scale ranging from 0 to 4, whereby higher scores reflect more severe alcohol use patterns. Responses are summed to reflect a total score ranging from 0 to 40, with higher scores reflecting higher severity of an individual's use of alcohol. | Posted | Mean | Standard Deviation | score on a scale | Two-months |
|
|
|
| Other Pre-specified | Composite Abuse Scale | 30 item measure of chronicity and occurrence of intimate partner violence with current partner in past 12 months. Score range from 0-150; higher scores indicate more intimate partner violence (i.e., worse outcome). | Posted | Mean | Standard Deviation | score on a scale | 2 month follow up |
|
|
|
| Other Pre-specified | PCL-5 | Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome). | Posted | Mean | Standard Deviation | score on a scale | 4 month follow-up |
|
|
|
| Other Pre-specified | Composite Abuse Scale | 30 item measure of chronicity and occurrence of intimate partner violence with current partner in past 12 months. Score range from 0-150; higher scores indicate more intimate partner violence (i.e., worse outcome). | Posted | Mean | Standard Deviation | score on a scale | 4 month follow-up |
|
|
|
| Other Pre-specified | PCL-5 | Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome). | Posted | Mean | Standard Deviation | score on a scale | 2 month follow up |
|
|
|
| Other Pre-specified | 30-day Alcohol Timeline Follow Back | Calendar-assisted measure used to garner a retrospective account of drinking behavior. Scale is in standard alcoholic drinks in an average week in the past month. Higher numbers indicate more drinks per week (i.e., worse outcome). | Posted | Mean | Standard Deviation | Drinks per week in the past month | 4 month follow-up |
|
|
|
| Other Pre-specified | 30-day Alcohol Timeline Follow Back | Calendar-assisted measure used to garner a retrospective account of drinking behavior. Scale is in standard alcoholic drinks in an average week in the past month. Higher numbers indicate more drinks per week (i.e., worse outcome). | Posted | Mean | Standard Deviation | Drinks per week in the past month | 2 month follow up |
|
|
|
| Other Pre-specified | Satisfaction With CIAS Software Scale | Assesses participant satisfaction with the computerized software with items on likeability, ease of use, level of interest, and respectfulness. Score range is 7-35; higher numbers indicate higher satisfaction with the software (i.e., better outcome). | Posted | Mean | Standard Deviation | score on a scale | time zero (completed immediately after participant receives intervention session) |
|
|
|
| 0 |
| 76 |
| 15 |
| 76 |
| 0 |
| 76 |
| EG001 | Control | Participants randomized to this arm will receive referrals to VA and community resources | 0 | 77 | 12 | 77 | 1 | 77 |
| IPV-Physical-Sought no medical care | Injury, poisoning and procedural complications | Systematic Assessment |
|
| IPV-Verbal threat | Social circumstances | Systematic Assessment |
|
| Hospitalization-Appendicitis | Surgical and medical procedures | Systematic Assessment |
|
| Hospitalization-Suicide attempt | Psychiatric disorders | Systematic Assessment |
|
| Hospitalization-General medical issue | General disorders | Systematic Assessment |
|
| Hospitalization-Depression/Heavy drinking | Psychiatric disorders | Systematic Assessment |
|
| Hospitalization-Abdominal surgery | Surgical and medical procedures | Systematic Assessment |
|
| Hospitalization-General medical issue | Surgical and medical procedures | Systematic Assessment |
|
| Sexual assault-Non-IPV | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Physical assault-Non-IPV | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Car accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| IPV-Physical-Doctor's Visit | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hospitalization-Inpatient-Psych | Psychiatric disorders | Systematic Assessment |
|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| D064419 | Chemically-Induced Disorders |