Trial Outcomes & Findings for Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE) (NCT NCT03261700)
NCT ID: NCT03261700
Last Updated: 2023-07-27
Results Overview
Measures change in sense of personal empowerment; minimum value = 28 and maximum score = 196; higher scores indicate higher personal empowerment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline,10-week follow-up, and 14-week follow-up assessments
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
RISE
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
RISE
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Overall Study
The participant was not able to participate due to COVID-19 related stressors.
|
1
|
0
|
Baseline Characteristics
Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE)
Baseline characteristics by cohort
| Measure |
RISE
n=30 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 10.8 • n=93 Participants
|
40.5 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
39.1 years
STANDARD_DEVIATION 11.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Sexual orientation
Heterosexual
|
19 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Sexual orientation
Lesbian/Gay
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sexual orientation
Bisexual
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sexual orientation
Pansexual
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline,10-week follow-up, and 14-week follow-up assessmentsPopulation: Intent-to-treat (ITT) sample
Measures change in sense of personal empowerment; minimum value = 28 and maximum score = 196; higher scores indicate higher personal empowerment
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Empowerment Via the Personal Progress Scale Revised
Baseline
|
129.82 score on a scale
Interval 121.91 to 137.73
|
132.25 score on a scale
Interval 123.64 to 140.87
|
|
Empowerment Via the Personal Progress Scale Revised
10-Week Follow-up
|
146.13 score on a scale
Interval 137.8 to 154.46
|
137.24 score on a scale
Interval 129.85 to 144.63
|
|
Empowerment Via the Personal Progress Scale Revised
14-Week Follow-up
|
148.07 score on a scale
Interval 139.62 to 156.52
|
137.66 score on a scale
Interval 130.15 to 145.17
|
PRIMARY outcome
Timeframe: Baseline, 10-week follow-up, and 14-week follow-up assessmentsPopulation: Intent-to-Treat (ITT) sample
This scale is a self-report of change in general self-efficacy; minimum score = 4 and maximum score = 40; higher scores indicate higher self-efficacy
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Self-efficacy Via the General Self-Efficacy Scale
Baseline
|
28.7 score on a scale
Interval 27.04 to 30.36
|
29.90 score on a scale
Interval 27.98 to 31.82
|
|
Self-efficacy Via the General Self-Efficacy Scale
10-Week Follow-up
|
33.33 score on a scale
Interval 31.75 to 34.91
|
30.66 score on a scale
Interval 29.01 to 32.31
|
|
Self-efficacy Via the General Self-Efficacy Scale
14-Week Follow-up
|
34.07 score on a scale
Interval 32.53 to 35.61
|
30.52 score on a scale
Interval 28.95 to 32.09
|
PRIMARY outcome
Timeframe: Baseline, 10-week follow-up, and 14-week follow-up assessmentsPopulation: Intent-to-Treat (ITT) sample
Measures change in valued living, and congruence between stated values and past-week valued behavior; Composite scores range from 10 (minimum) to 100 (maximum). Higher scores reflect higher valued living (i.e., an indicator of higher quality of life)
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Valued Living Questionnaire
Baseline
|
49.88 score on a scale
Interval 42.97 to 56.79
|
48.88 score on a scale
Interval 42.87 to 54.89
|
|
Valued Living Questionnaire
10-Week Follow-up
|
63.27 score on a scale
Interval 56.68 to 69.86
|
53.44 score on a scale
Interval 46.86 to 60.02
|
|
Valued Living Questionnaire
14-Week Follow-Up
|
60.96 score on a scale
Interval 52.62 to 69.3
|
57.23 score on a scale
Interval 50.51 to 63.95
|
PRIMARY outcome
Timeframe: Baseline, 10-week follow-up, and 14-week follow-up assessmentsPopulation: Intent-to-Treat (ITT) Sample
Measures change in patient engagement in needed health care; scores are transferred to a theoretical 0-100 scale; higher scores indicate higher patient activation.
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Patient Activation Measure (PAM-13)
Baseline
|
65.89 score on a scale
Interval 59.19 to 72.58
|
64.62 score on a scale
Interval 58.64 to 70.61
|
|
Patient Activation Measure (PAM-13)
10-week follow-up assessment
|
76.5 score on a scale
Interval 69.49 to 83.51
|
69.24 score on a scale
Interval 64.3 to 74.19
|
|
Patient Activation Measure (PAM-13)
14-week follow-up assessment
|
75.5 score on a scale
Interval 67.87 to 83.13
|
70.12 score on a scale
Interval 65.5 to 74.65
|
SECONDARY outcome
Timeframe: Baseline, 10-week follow-up, and 14-week follow-up assessmentsPopulation: Intent-to-Treat (ITT) Sample
Measures change in DSM-5 PTSD symptom severity. Scores range from 0-80; higher scores reflect higher/worse PTSD symptoms.
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
PTSD Checklist for DSM-5
Baseline
|
41.92 score on a scale
Interval 35.98 to 47.85
|
39.97 score on a scale
Interval 34.2 to 45.73
|
|
PTSD Checklist for DSM-5
10-week assessment
|
29.97 score on a scale
Interval 22.69 to 36.72
|
36.97 score on a scale
Interval 31.25 to 42.68
|
|
PTSD Checklist for DSM-5
14-week assessment
|
32.73 score on a scale
Interval 25.11 to 40.35
|
32.13 score on a scale
Interval 25.61 to 38.65
|
SECONDARY outcome
Timeframe: Baseline, 10-week follow-up, and 14-week follow-up assessmentsPopulation: Intent-to-treat (ITT) sample
Measures change in depressive symptoms; This measure ranges from 0-60; higher scores reflect (worse) higher levels of symptoms
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Center for Epidemiological Studies-Depression Scale
Baseline
|
27.21 score on a scale
Interval 23.38 to 31.04
|
24.50 score on a scale
Interval 20.29 to 28.71
|
|
Center for Epidemiological Studies-Depression Scale
10-week follow-up
|
19.59 score on a scale
Interval 14.84 to 24.34
|
22.76 score on a scale
Interval 19.36 to 26.16
|
|
Center for Epidemiological Studies-Depression Scale
14-week follow-up
|
21.12 score on a scale
Interval 15.77 to 26.47
|
19.72 score on a scale
Interval 15.32 to 24.12
|
SECONDARY outcome
Timeframe: Baseline, 10-Week follow-up, and 14-Week follow-up AssessmentsPopulation: Intent-to-treat (ITT) sample
Measures change in physical-health related quality of life. Specifically, quantitative ratings of overall physical health functioning were rated on a Likert scale of 1-5 (1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor).
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
SF-12 Health Survey
Baseline
|
3 score on a scale
Standard Deviation .87
|
3 score on a scale
Standard Deviation .77
|
|
SF-12 Health Survey
10-Week Follow-Up
|
3 score on a scale
Standard Deviation .87
|
2 score on a scale
Standard Deviation .74
|
|
SF-12 Health Survey
14-Week Follow-Up
|
3 score on a scale
Standard Deviation .76
|
3 score on a scale
Standard Deviation .87
|
SECONDARY outcome
Timeframe: Baseline, 10-week follow-up, and 14-week follow-up assessmentsPopulation: ITT sample
Measures change in overall number of different IPV acts over time (i.e., total count score). This measure ranges from 0-33; higher scores reflect higher levels of IPV (i.e., a worse outcome).
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Conflict Tactic Scales Revised
Baseline
|
11.17 units on a scale (count scores)
Interval 8.15 to 14.2
|
11.67 units on a scale (count scores)
Interval 9.14 to 14.2
|
|
Conflict Tactic Scales Revised
10-Week Follow-up
|
3.37 units on a scale (count scores)
Interval 2.2 to 4.54
|
4.93 units on a scale (count scores)
Interval 2.56 to 7.3
|
|
Conflict Tactic Scales Revised
14-Week Follow-up
|
3.34 units on a scale (count scores)
Interval 1.17 to 5.51
|
2.8 units on a scale (count scores)
Interval 1.76 to 3.84
|
SECONDARY outcome
Timeframe: Baseline, 10-week follow-up, and 14-week follow-up assessmentsPopulation: Intent-to-treat (ITT) sample
Measures overall number of VA and non-VA health care visits (inclusive of physical, mental health, and social service use visits).
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Physical, Mental and Social Service Care Use
Baseline
|
8.27 visits
Interval 6.31 to 10.23
|
7.03 visits
Interval 5.29 to 8.77
|
|
Physical, Mental and Social Service Care Use
10-Week Follow-Up
|
6.15 visits
Interval 4.44 to 7.86
|
6.24 visits
Interval 4.69 to 7.79
|
|
Physical, Mental and Social Service Care Use
14-Week Follow-Up
|
4.62 visits
Interval 3.18 to 6.05
|
4.93 visits
Interval 3.35 to 6.52
|
SECONDARY outcome
Timeframe: 10-week follow-up assessmentPopulation: Intent-to-Treat (ITT) Sample
Measures satisfaction with treatment; Scores range from 8 to 32; higher scores reflect higher satisfaction with treatment (i.e., a better outcome)
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Client Services Questionnaire (CSQ-8)
|
29.30 score on a scale
Standard Deviation 2.78
|
25.07 score on a scale
Standard Deviation 4.85
|
SECONDARY outcome
Timeframe: Baseline, 10-week follow-up, and 14-week follow-up assessmentsPopulation: Intent-to-treat (ITT) sample
Measures change in somatic and physical health symptoms; score ranges from 0 to 30, with higher scores representing higher levels of physical health problems
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Patient Health Questionnaire
Baseline
|
12.52 score on a scale
Interval 10.41 to 14.63
|
10.60 score on a scale
Interval 9.03 to 12.16
|
|
Patient Health Questionnaire
10-Week Follow-Up
|
11.37 score on a scale
Interval 9.33 to 13.41
|
12.01 score on a scale
Interval 10.27 to 13.75
|
|
Patient Health Questionnaire
14-Week Follow-Up
|
11.42 score on a scale
Interval 8.99 to 13.85
|
9.69 score on a scale
Interval 8.01 to 11.36
|
SECONDARY outcome
Timeframe: Baseline, 10-week follow-up, and 14-week follow-up assessmentsPopulation: Intent-to-treat (ITT) sample
Measures the present use of safety behaviors participants are currently using to protect themselves. Each of the 15 items of this measure corresponds to a specific safety behavior. Participant indicates whether they have used each behavior using a dichotomous response option (yes = 1; no = 0). Scores are summed, with total scores ranging from 0-15. Higher scores indicate a higher number of safety behaviors enacted.
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Safety Behaviors Checklist
Baseline
|
12.87 score on a scale
Interval 11.97 to 13.77
|
12.94 score on a scale
Interval 12.09 to 13.79
|
|
Safety Behaviors Checklist
10-Week Follow-Up
|
13.04 score on a scale
Interval 11.59 to 14.49
|
12.39 score on a scale
Interval 10.79 to 13.99
|
|
Safety Behaviors Checklist
14-Week Follow-Up
|
9.4 score on a scale
Interval 6.85 to 11.95
|
12.34 score on a scale
Interval 10.75 to 13.93
|
SECONDARY outcome
Timeframe: Baseline, 10-week follow-up, and 14-week follow-up assessmentsPopulation: Intent-to-treat (ITT) sample
Measures patient resilience; Scores range from 0-100,with higher scores reflecting higher resilience
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Connor-Davidson Resilience Scale
10-Week Follow-Up
|
29.67 score on a scale
Interval 27.24 to 32.09
|
26 score on a scale
Interval 23.9 to 28.1
|
|
Connor-Davidson Resilience Scale
14-Week Follow-Up
|
29.65 score on a scale
Interval 26.9 to 32.41
|
26.07 score on a scale
Interval 23.8 to 28.34
|
|
Connor-Davidson Resilience Scale
Baseline
|
25.43 score on a scale
Interval 23.28 to 27.59
|
24.1 score on a scale
Interval 21.87 to 26.33
|
SECONDARY outcome
Timeframe: Baseline, 10-week follow-up, and 14-week follow-up assessmentsPopulation: Intent-to-treat (ITT) sample
Measures anxiety symptom severity; Scores range from 0-42, with higher scores indicating higher levels of anxiety.
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Depression Anxiety Stress Scale- Anxiety Subscale
Baseline
|
25.11 score on a scale
Interval 21.83 to 28.38
|
23.4 score on a scale
Interval 20.68 to 26.12
|
|
Depression Anxiety Stress Scale- Anxiety Subscale
10-Week Follow-Up
|
22.67 score on a scale
Interval 18.92 to 26.41
|
22.98 score on a scale
Interval 20.72 to 25.24
|
|
Depression Anxiety Stress Scale- Anxiety Subscale
14-Week Follow-Up
|
23.58 score on a scale
Interval 19.88 to 27.28
|
21.22 score on a scale
Interval 19.02 to 23.42
|
SECONDARY outcome
Timeframe: Baseline, 10-week follow-up, and 14-week follow-up assessmentsPopulation: Intent-to-treat (ITT) sample
Measures engagement coping skills; Scores range from 8-40, with higher score reflecting better coping
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Coping Strategies Inventory - Short Form
Baseline
|
26.42 mean score on a scale
Interval 25.22 to 27.61
|
25.69 mean score on a scale
Interval 24.66 to 26.71
|
|
Coping Strategies Inventory - Short Form
14-Week Follow-Up
|
26.92 mean score on a scale
Interval 25.72 to 28.13
|
25.4 mean score on a scale
Interval 24.5 to 26.3
|
|
Coping Strategies Inventory - Short Form
10-Week Follow-Up
|
27.30 mean score on a scale
Interval 25.99 to 28.61
|
25.74 mean score on a scale
Interval 24.71 to 26.78
|
SECONDARY outcome
Timeframe: Assessed at 10-week follow-up or 14-week follow-up, values at the end of 14 weeks reportedPopulation: Intent-to-Treat sample with completed helpfulness ratings at the 10- or 14-week follow-up assessments. From the RISE condition, 26 participants completed this assessment at the 10-week follow-up, and the remaining 3 completed it at the 14-week follow-up. From the Information and Referral condition, 29 participants completed this assessment at the 10-week follow-up and 1 participant completed it at the 14-week follow-up. Thus, the data represents summed count scores for each endorsed answer.
Semi-structured qualitative interview questions developed for the purpose of this study to assess participants' perceptions of the acceptability, with a particular item to assess overall helpfulness of the intervention. Specifically, quantitative ratings of overall helpfulness were rated on a Likert scale of 1-5 (1=highly helpful, 2 = somewhat helpful, 3 = neither helpful nor unhelpful, 4 = somewhat unhelpful, 5=highly unhelpful).
Outcome measures
| Measure |
RISE
n=29 Participants
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 Participants
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.
'Neither helpful or unhelpful'
|
0 Participants
|
0 Participants
|
|
Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.
'Somewhat unhelpful'
|
0 Participants
|
0 Participants
|
|
Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.
'Highly helpful'
|
23 Participants
|
16 Participants
|
|
Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.
'Somewhat helpful'
|
6 Participants
|
14 Participants
|
|
Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.
'Highly unhelpful'
|
0 Participants
|
0 Participants
|
Adverse Events
RISE
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Care as Usual Condition
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RISE
n=30 participants at risk
This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
|
Enhanced Care as Usual Condition
n=30 participants at risk
This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
|
|---|---|---|
|
General disorders
hospitalized for medical condition
|
13.3%
4/30 • 10-14 weeks following enrollment
|
3.3%
1/30 • 10-14 weeks following enrollment
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Katherine Iverson, PI
National Center for PTSD, located at the VA Boston Healthcare System
Phone: 857-364-2066
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place