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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

153 participants

Primary outcome timeframe

Two months

Results posted on

2021-01-05

Participant Flow

Participant milestones

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

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

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 months

Population: intent to treat sample

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

Outcome measures

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 months

Population: intent to treat sample

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

Outcome measures

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 month

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).

Outcome measures

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 month

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).

Outcome measures

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

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 month

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).

Outcome measures

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 month

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).

Outcome measures

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-months

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.

Outcome measures

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-months

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.

Outcome measures

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 up

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).

Outcome measures

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-up

Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).

Outcome measures

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-up

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).

Outcome measures

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 up

Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).

Outcome measures

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-up

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).

Outcome measures

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 up

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).

Outcome measures

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

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

Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 12 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

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

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

Phone: 254-297-3025

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place