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Addressing the Health Concerns of VA Women With Sexual Trauma
NA trial testing SHE in Stress Disorders, Post-Traumatic in 153 participants. Completed in 1 May 2020.
| Lead sponsor | VISN 17 Center of Excellence |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 153 |
| Start date | 12 June 2017 |
| Primary completion | 30 August 2019 |
| Estimated completion | 1 May 2020 |
| Sites | 2 locations across United States |
VISN 17 Center of Excellence
Adults 18 to 65, female only, with Stress Disorders, Post-Traumatic or Intimate Partner Violence. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)
| Group | Value | 95% CI |
|---|---|---|
| Safety and Health Experiences Program | 1.38 | ± .85 |
| Control | 1.05 | ± .93 |
Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)
| Group | Value | 95% CI |
|---|---|---|
| Safety and Health Experiences Program | 1.14 | ± .81 |
| Control | 1.00 | ± .81 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Safety and Health Experiences Program | 7.32 | ± 10.41 |
| Control | 3.89 | ± 5.56 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Safety and Health Experiences Program | 4.59 | ± 7.34 |
| Control | 5.03 | ± 16.77 |
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).
| Group | Value | 95% CI |
|---|---|---|
| SHE/Safe and Healthy Experiences Intervention | 26.25 | ± 4.0 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Safety and Health Experiences Program | 1.42 | ± 1.43 |
| Control | 1.88 | ± 2.17 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Safety and Health Experiences Program | 1.48 | ± 1.67 |
| Control | 1.7 | ± 1.68 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Safety and Health Experiences Program | 4.52 | ± 5.54 |
| Control | 4.42 | ± 5.01 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Safety and Health Experiences Program | 4.65 | ± 5.07 |
| Control | 5.27 | ± 5.60 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Safety and Health Experiences Program | 11.25 | ± 13.87 |
| Control | 6.17 | ± 9.60 |
Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).
| Group | Value | 95% CI |
|---|---|---|
| Safety and Health Experiences Program | 45.26 | ± 17.01 |
| Control | 44.81 | ± 18.29 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Safety and Health Experiences Program | 7.03 | ± 11.76 |
| Control | 5.48 | ± 10.76 |
Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Safety and Health Experien… | Control |
|---|---|---|---|
| IPV-Physical-Sought no medical care | Injury, poisoning and procedural complications | — | — |
| Hospitalization-General medical issue | General disorders | — | — |
| Sexual assault-Non-IPV | Injury, poisoning and procedural complications | — | — |
| Hospitalization-Vertigo | General disorders | — | — |
| IPV-Verbal threat | Social circumstances | — | — |
| Hospitalization-Appendicitis | Surgical and medical procedures | — | — |
| Hospitalization-Suicide attempt | Psychiatric disorders | — | — |
| Hospitalization-Depression/Heavy drinking | Psychiatric disorders | — | — |
| Hospitalization-Abdominal surgery | Surgical and medical procedures | — | — |
| Hospitalization-General medical issue | Surgical and medical procedures | — | — |
| Physical assault-Non-IPV | Injury, poisoning and procedural complications | — | — |
| Car accident | Injury, poisoning and procedural complications | — | — |
| IPV-Physical-Doctor's Visit | Injury, poisoning and procedural complications | — | — |
| Hospitalization-Inpatient-Psych | Psychiatric disorders | — | — |
| Miscarriage | Pregnancy, puerperium and perinatal conditions | — | — |
| Reaction | System | Safety and Health Experien… | Control |
|---|---|---|---|
| Feeling unsafe at home-heard gunshots in neighborhood | Social circumstances | — | — |
Most-reported serious reactions: IPV-Physical-Sought no medical care, Hospitalization-General medical issue, Sexual assault-Non-IPV, Hospitalization-Vertigo, IPV-Verbal threat, Hospitalization-Appendicitis, Hospitalization-Suicide attempt, Hospitalization-Depression/Heavy drinking.
Data from ClinicalTrials.gov NCT02957747 adverse events section.
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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