Trial Outcomes & Findings for Addressing the Health Concerns of VA Women With Sexual Trauma (NCT NCT02957747)
NCT ID: NCT02957747
Last Updated: 2021-01-05
Results Overview
Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)
COMPLETED
NA
153 participants
Two months
2021-01-05
Participant Flow
Participant milestones
| Measure |
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.
|
Control
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
77
|
|
Overall Study
COMPLETED
|
66
|
69
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
| Measure |
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.
|
Control
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
10
|
5
|
Baseline Characteristics
Addressing the Health Concerns of VA Women With Sexual Trauma
Baseline characteristics by cohort
| Measure |
Safety and Health Experiences Program
n=76 Participants
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.
|
Control
n=77 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
76 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
43.46 years
STANDARD_DEVIATION 9.97 • n=99 Participants
|
43.63 years
STANDARD_DEVIATION 10.28 • n=107 Participants
|
43.55 years
STANDARD_DEVIATION 10.10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=99 Participants
|
77 participants
n=107 Participants
|
153 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Two monthsPopulation: intent to treat sample
Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)
Outcome measures
| Measure |
Safety and Health Experiences Program
n=76 Participants
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.
|
Control
n=77 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Change in Number of Health Risks
|
1.38 number of risks
Standard Deviation .85
|
1.05 number of risks
Standard Deviation .93
|
PRIMARY outcome
Timeframe: Four monthsPopulation: intent to treat sample
Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)
Outcome measures
| Measure |
Safety and Health Experiences Program
n=76 Participants
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.
|
Control
n=77 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Change in Number of Health Risks
|
1.14 number of risks
Standard Deviation .81
|
1.00 number of risks
Standard Deviation .81
|
SECONDARY outcome
Timeframe: 2 monthSelf-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).
Outcome measures
| Measure |
Safety and Health Experiences Program
n=76 Participants
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.
|
Control
n=77 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Adapted Treatment Services Review
|
7.32 score on a scale
Standard Deviation 10.41
|
3.89 score on a scale
Standard Deviation 5.56
|
SECONDARY outcome
Timeframe: 4 monthSelf-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).
Outcome measures
| Measure |
Safety and Health Experiences Program
n=76 Participants
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.
|
Control
n=77 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Adapted Treatment Services Review
|
4.59 score on a scale
Standard Deviation 7.34
|
5.03 score on a scale
Standard Deviation 16.77
|
SECONDARY outcome
Timeframe: time zero (completed immediately after participant receives intervention session)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).
Outcome measures
| Measure |
Safety and Health Experiences Program
n=76 Participants
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.
|
Control
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
The Client Satisfaction Questionnaire
|
26.25 score on a scale
Standard Deviation 4.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 monthAssesses 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).
Outcome measures
| Measure |
Safety and Health Experiences Program
n=76 Participants
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.
|
Control
n=77 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Effectiveness in Obtaining Resources Scale
|
1.42 score on a scale
Standard Deviation 1.43
|
1.88 score on a scale
Standard Deviation 2.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 monthAssesses 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).
Outcome measures
| Measure |
Safety and Health Experiences Program
n=76 Participants
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.
|
Control
n=77 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Effectiveness in Obtaining Resources Scale
|
1.48 score on a scale
Standard Deviation 1.67
|
1.7 score on a scale
Standard Deviation 1.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Four-monthsThe 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.
Outcome measures
| Measure |
Safety and Health Experiences Program
n=76 Participants
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.
|
Control
n=77 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Alcohol Use Disorder Identification Test (AUDIT)
|
4.52 score on a scale
Standard Deviation 5.54
|
4.42 score on a scale
Standard Deviation 5.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Two-monthsThe 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.
Outcome measures
| Measure |
Safety and Health Experiences Program
n=76 Participants
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.
|
Control
n=77 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Alcohol Use Disorder Identification Test (AUDIT)
|
4.65 score on a scale
Standard Deviation 5.07
|
5.27 score on a scale
Standard Deviation 5.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 month follow up30 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).
Outcome measures
| Measure |
Safety and Health Experiences Program
n=45 Participants
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.
|
Control
n=47 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Composite Abuse Scale
|
11.25 score on a scale
Standard Deviation 13.87
|
6.17 score on a scale
Standard Deviation 9.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 month follow-upSymptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).
Outcome measures
| Measure |
Safety and Health Experiences Program
n=55 Participants
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.
|
Control
n=43 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
PCL-5
|
45.26 score on a scale
Standard Deviation 17.01
|
44.81 score on a scale
Standard Deviation 18.29
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 month follow-up30 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).
Outcome measures
| Measure |
Safety and Health Experiences Program
n=45 Participants
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.
|
Control
n=47 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Composite Abuse Scale
|
7.03 score on a scale
Standard Deviation 11.76
|
5.48 score on a scale
Standard Deviation 10.76
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 month follow upSymptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).
Outcome measures
| Measure |
Safety and Health Experiences Program
n=55 Participants
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.
|
Control
n=42 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
PCL-5
|
47.16 score on a scale
Standard Deviation 17.54
|
42.91 score on a scale
Standard Deviation 19.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 month follow-upCalendar-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).
Outcome measures
| Measure |
Safety and Health Experiences Program
n=28 Participants
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.
|
Control
n=30 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
30-day Alcohol Timeline Follow Back
|
8.5 Drinks per week in the past month
Standard Deviation 11.27
|
8.24 Drinks per week in the past month
Standard Deviation 9.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 month follow upCalendar-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).
Outcome measures
| Measure |
Safety and Health Experiences Program
n=28 Participants
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.
|
Control
n=30 Participants
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
30-day Alcohol Timeline Follow Back
|
10.26 Drinks per week in the past month
Standard Deviation 10.84
|
8.26 Drinks per week in the past month
Standard Deviation 9.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: time zero (completed immediately after participant receives intervention session)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).
Outcome measures
| Measure |
Safety and Health Experiences Program
n=76 Participants
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.
|
Control
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Satisfaction With CIAS Software Scale
|
30.92 score on a scale
Standard Deviation .56
|
—
|
Adverse Events
Safety and Health Experiences Program
Control
Serious adverse events
| Measure |
Safety and Health Experiences Program
n=76 participants at risk
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.
|
Control
n=77 participants at risk
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
General disorders
Hospitalization-Vertigo
|
0.00%
0/76 • 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.
|
1.3%
1/77 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
IPV-Physical-Sought no medical care
|
9.2%
7/76 • Number of events 7 • 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.
|
9.1%
7/77 • Number of events 9 • 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.
|
|
Social circumstances
IPV-Verbal threat
|
1.3%
1/76 • Number of events 1 • 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.
|
0.00%
0/77 • 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.
|
|
Surgical and medical procedures
Hospitalization-Appendicitis
|
1.3%
1/76 • Number of events 1 • 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.
|
0.00%
0/77 • 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.
|
|
Psychiatric disorders
Hospitalization-Suicide attempt
|
1.3%
1/76 • Number of events 1 • 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.
|
0.00%
0/77 • 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.
|
|
General disorders
Hospitalization-General medical issue
|
1.3%
1/76 • Number of events 1 • 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.
|
2.6%
2/77 • Number of events 2 • 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.
|
|
Psychiatric disorders
Hospitalization-Depression/Heavy drinking
|
0.00%
0/76 • 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.
|
1.3%
1/77 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Hospitalization-Abdominal surgery
|
1.3%
1/76 • Number of events 1 • 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.
|
1.3%
1/77 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Hospitalization-General medical issue
|
0.00%
0/76 • 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.
|
1.3%
1/77 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Sexual assault-Non-IPV
|
2.6%
2/76 • Number of events 2 • 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.
|
0.00%
0/77 • 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.
|
|
Injury, poisoning and procedural complications
Physical assault-Non-IPV
|
1.3%
1/76 • Number of events 1 • 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.
|
0.00%
0/77 • 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.
|
|
Injury, poisoning and procedural complications
Car accident
|
0.00%
0/76 • 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.
|
1.3%
1/77 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
IPV-Physical-Doctor's Visit
|
1.3%
1/76 • Number of events 1 • 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.
|
0.00%
0/77 • 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.
|
|
Psychiatric disorders
Hospitalization-Inpatient-Psych
|
0.00%
0/76 • 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.
|
1.3%
1/77 • Number of events 1 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
0.00%
0/76 • 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.
|
1.3%
1/77 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Safety and Health Experiences Program
n=76 participants at risk
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.
|
Control
n=77 participants at risk
Participants randomized to this arm will receive referrals to VA and community resources
|
|---|---|---|
|
Social circumstances
Feeling unsafe at home-heard gunshots in neighborhood
|
0.00%
0/76 • 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.
|
1.3%
1/77 • Number of events 1 • 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.
|
Additional Information
Dr. Suzannah Creech, Ph.D.
VISN 17 Center of Excellence for Research on Returning War Veterans
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place