Skip to content

Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE)

Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE): Tailoring and Evaluating a Patient-Centered Counseling Intervention for Women Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03261700
Acronym
RISE
Enrollment
60
Registered
2017-08-25
Start date
2018-10-22
Completion date
2020-11-23
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intimate Partner Violence, Self-efficacy

Keywords

women Veterans, interpersonal violence

Brief summary

Intimate partner violence (IPV) is a major health concern for women Veterans. IPV is associated with numerous physical and mental health conditions. VHA is implementing IPV screening programs to identify female patients who experience past-year IPV. Despite strong evidence that screening increases detection of IPV, less is established about how to intervene following IPV disclosure in health care settings, in order to improve health outcomes. Existing healthcare-based interventions result in minimal effects on health and well-being, likely because they are too brief and generic. In response, the PI has developed Recovering from IPV through Strengths and Empowerment (RISE), based on the IPV-related health care needs and preferences of women Veterans. RISE is designed to be delivered in primary care and is an individualized, variable-length, modular-based intervention that addresses * safety planning; * education on the health effects of IPV and warning signs; * increasing coping skills and self-care; * enhancing social support; * making difficult decisions; and * connecting with resources. This study is aimed at refining and evaluating RISE for use with female VA patients who have experienced past-year IPV. This brief counseling intervention is intended to be administered in conjunction with primary care, as this is a frequent point of healthcare contact for women Veterans and where disclosure of IPV is most prevalent.

Detailed description

Women are the fastest growing group of VHA patients, with their population recently increasing by 80%. Women Veterans (WV's) are at higher risk for IPV than their non-Veteran peers, with that 1 in 3 WVs report lifetime IPV, compared to 1 in 4 women in the general U.S. population. Research reports up to 30% of WVs experience past-year IPV. As a result, WVs are considered an important population for IPV screening and counseling interventions. In response, VHA Women's Health Services (WHS) and the IPV Assistance Program of Care Management and Social Work Services (CMSWS) are implementing IPV screening programs for women and are seeking an effective intervention to implement into care. Extant brief counseling interventions for IPV result in minimal effects on patients' health and safety. A recent review of IPV screening trials highlighted insufficient intensity of post-disclosure counseling interventions, concluding that existing interventions are too brief, unstructured, and generic. Such minimal intervention effects of the current standard of care have led leaders in the field to call for the development and testing of new and more comprehensive IPV interventions, especially for delivery in conjunction with primary care. The Recovering from IPV through Strengths and Empowerment (RISE) intervention fills this need. The PI, a clinical psychologist and health services researcher with expertise in and national recognition for IPV research and care, has developed an innovative IPV intervention to respond to this need. Recovering from IPV through Strengths and Empowerment (RISE) is based on the healthcare needs and preferences of WVs who have experienced IPV. RISE was developed using rigorous methods, building on the evidence base from the applicant's HSR&D CDA and on input of VHA primary care and behavioral health experts. RISE is based on empowerment, a highly relevant intervention model for women who experience IPV. It is an individualized, variable-length, modular-based intervention addressing key factors: * safety planning, * educating about the health effects of IPV and warning signs, * improving coping and self-care, * enhancing social support, * making difficult decisions, and * connecting with resources. RISE is rooted in empowerment and incorporates aspects of Motivational Interviewing, an evidence-based approach designed to facilitate behavior change that is widely used in VHA for numerous health issues. This timely research project addresses the critical gap in current IPV care. It will refine and formally evaluate RISE using established methods for rapid and efficient effectiveness testing, including a Hybrid 1 randomized clinical trial (RCT) to evaluate RISE that simultaneously gathers information on barriers to and facilitators of implementation. The study is guided by the first two phases of the Replicating Effective Programs (REP) framework, pre-conditions and pre-implementation. These phases emphasize tailoring interventions with stakeholder input and iterative cycles of pilot testing within routine practice conditions. Use of the REP framework will maximize the likelihood that RISE-should its effectiveness be demonstrated-can easily be integrated into routine care in VHA. The Specific Aims of this study are as follows: 1. Tailor and refine RISE to accommodate differences in service structures and personnel in different primary care settings through input from a Stakeholder Advisory Board, focus groups with WVs (four groups; n=24-32), and qualitative interviews with providers (n=24). 2. Conduct a formative evaluation of RISE with WVs (n=up to 20) to inform the development of a user-friendly, tailored implementation protocol and intervention manual. 3. Examine the effects of RISE on WVs' (n=60) individual psychosocial outcomes (e.g., empowerment, self-efficacy, health symptoms, service use, and quality of life) in an RCT that compares RISE to an information/referral condition. 3a. Evaluate the feasibility and acceptability of RISE in the context of the RCT. This study provides the groundwork to examine the effectiveness of RISE. The data will be used to demonstrate whether the effects of RISE appear promising to support a future-large scale effectiveness-implementation RCT, including the range of effect sizes that would be reasonable to expect in a future trial. The project was originally conducted at two Women's Health Practice-Based Research Network (PBRN) sites that have adopted IPV screening - the Women's Health Centers (WHC) at VA Boston Healthcare System and VA Connecticut Healthcare System. RCT study enrollment was discontinued at VA Connecticut in July 2019 due to low enrollment. The VA Boston Healthcare System serves as the sole site for data collection from July 2019 on and is the sourced of the RCT data. The COVID-19 pandemic resulted in modifications to IRB protocol to switch from in-person enrollment, assessments and sessions. There were several women actively involved in the trial during the initial shut-down. New recruitment and enrollment were temporarily hauled during early months of COVID-19, with virtual enrollment beginning as of July 2020. Recruitment and enrollment were completed in September 2020 because the enrollment goals were met and the planned sample size was obtained (N=60).

Interventions

BEHAVIORALRISE

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.

OTHERInformation 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).

Sponsors

VA Boston Healthcare System
CollaboratorFED
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Open label

Intervention model description

For the RCT (Aim 3), participants will be randomized to RISE or an information and referral condition.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants will be eligible to participate if they: * Self-identify as a woman * Are at least 18 years of age * A patient at VA Boston Healthcare System * Self- reported that they have experienced past-year physical, sexual, or psychological IPV * Ability to understand study procedures in English * Not exhibiting symptoms of mania or psychosis * Not actively in suicidal crisis warranting imminent hospitalization

Exclusion criteria

* Any violation of inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Empowerment Via the Personal Progress Scale RevisedBaseline,10-week follow-up, and 14-week follow-up assessmentsMeasures change in sense of personal empowerment; minimum value = 28 and maximum score = 196; higher scores indicate higher personal empowerment
Self-efficacy Via the General Self-Efficacy ScaleBaseline, 10-week follow-up, and 14-week follow-up assessmentsThis scale is a self-report of change in general self-efficacy; minimum score = 4 and maximum score = 40; higher scores indicate higher self-efficacy
Valued Living QuestionnaireBaseline, 10-week follow-up, and 14-week follow-up assessmentsMeasures 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)
Patient Activation Measure (PAM-13)Baseline, 10-week follow-up, and 14-week follow-up assessmentsMeasures change in patient engagement in needed health care; scores are transferred to a theoretical 0-100 scale; higher scores indicate higher patient activation.

Secondary

MeasureTime frameDescription
Physical, Mental and Social Service Care UseBaseline, 10-week follow-up, and 14-week follow-up assessmentsMeasures overall number of VA and non-VA health care visits (inclusive of physical, mental health, and social service use visits).
Client Services Questionnaire (CSQ-8)10-week follow-up assessmentMeasures satisfaction with treatment; Scores range from 8 to 32; higher scores reflect higher satisfaction with treatment (i.e., a better outcome)
Patient Health QuestionnaireBaseline, 10-week follow-up, and 14-week follow-up assessmentsMeasures change in somatic and physical health symptoms; score ranges from 0 to 30, with higher scores representing higher levels of physical health problems
Safety Behaviors ChecklistBaseline, 10-week follow-up, and 14-week follow-up assessmentsMeasures 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.
Center for Epidemiological Studies-Depression ScaleBaseline, 10-week follow-up, and 14-week follow-up assessmentsMeasures change in depressive symptoms; This measure ranges from 0-60; higher scores reflect (worse) higher levels of symptoms
Depression Anxiety Stress Scale- Anxiety SubscaleBaseline, 10-week follow-up, and 14-week follow-up assessmentsMeasures anxiety symptom severity; Scores range from 0-42, with higher scores indicating higher levels of anxiety.
Coping Strategies Inventory - Short FormBaseline, 10-week follow-up, and 14-week follow-up assessmentsMeasures engagement coping skills; Scores range from 8-40, with higher score reflecting better coping
Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.Assessed at 10-week follow-up or 14-week follow-up, values at the end of 14 weeks reportedSemi-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).
Connor-Davidson Resilience ScaleBaseline, 10-week follow-up, and 14-week follow-up assessmentsMeasures patient resilience; Scores range from 0-100,with higher scores reflecting higher resilience
PTSD Checklist for DSM-5Baseline, 10-week follow-up, and 14-week follow-up assessmentsMeasures change in DSM-5 PTSD symptom severity. Scores range from 0-80; higher scores reflect higher/worse PTSD symptoms.
SF-12 Health SurveyBaseline, 10-Week follow-up, and 14-Week follow-up AssessmentsMeasures 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).
Conflict Tactic Scales RevisedBaseline, 10-week follow-up, and 14-week follow-up assessmentsMeasures 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
30
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).
30
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyThe participant was not able to participate due to COVID-19 related stressors.10

Baseline characteristics

CharacteristicRISEEnhanced Care as Usual ConditionTotal
Age, Continuous37.7 years
STANDARD_DEVIATION 10.8
40.5 years
STANDARD_DEVIATION 13
39.1 years
STANDARD_DEVIATION 11.9
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants5 Participants12 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
23 Participants25 Participants48 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Black or African American
8 Participants5 Participants13 Participants
Race (NIH/OMB)
More than one race
3 Participants5 Participants8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
17 Participants16 Participants33 Participants
Region of Enrollment
United States
30 Participants30 Participants60 Participants
Sex: Female, Male
Female
30 Participants30 Participants60 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Sexual orientation
Bisexual
5 Participants4 Participants9 Participants
Sexual orientation
Heterosexual
19 Participants24 Participants43 Participants
Sexual orientation
Lesbian/Gay
3 Participants1 Participants4 Participants
Sexual orientation
Pansexual
3 Participants1 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 30
other
Total, other adverse events
0 / 300 / 30
serious
Total, serious adverse events
4 / 301 / 30

Outcome results

Primary

Empowerment Via the Personal Progress Scale Revised

Measures change in sense of personal empowerment; minimum value = 28 and maximum score = 196; higher scores indicate higher personal empowerment

Time frame: Baseline,10-week follow-up, and 14-week follow-up assessments

Population: Intent-to-treat (ITT) sample

ArmMeasureGroupValue (MEAN)
RISEEmpowerment Via the Personal Progress Scale RevisedBaseline129.82 score on a scale
RISEEmpowerment Via the Personal Progress Scale Revised10-Week Follow-up146.13 score on a scale
RISEEmpowerment Via the Personal Progress Scale Revised14-Week Follow-up148.07 score on a scale
Enhanced Care as Usual ConditionEmpowerment Via the Personal Progress Scale RevisedBaseline132.25 score on a scale
Enhanced Care as Usual ConditionEmpowerment Via the Personal Progress Scale Revised10-Week Follow-up137.24 score on a scale
Enhanced Care as Usual ConditionEmpowerment Via the Personal Progress Scale Revised14-Week Follow-up137.66 score on a scale
Comparison: Comparison of groups on Empowerment via the Personal Progress Scale Revisedp-value: <0.05Mixed Models Analysis
Primary

Patient Activation Measure (PAM-13)

Measures change in patient engagement in needed health care; scores are transferred to a theoretical 0-100 scale; higher scores indicate higher patient activation.

Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments

Population: Intent-to-Treat (ITT) Sample

ArmMeasureGroupValue (MEAN)
RISEPatient Activation Measure (PAM-13)Baseline65.89 score on a scale
RISEPatient Activation Measure (PAM-13)10-week follow-up assessment76.5 score on a scale
RISEPatient Activation Measure (PAM-13)14-week follow-up assessment75.5 score on a scale
Enhanced Care as Usual ConditionPatient Activation Measure (PAM-13)Baseline64.62 score on a scale
Enhanced Care as Usual ConditionPatient Activation Measure (PAM-13)10-week follow-up assessment69.24 score on a scale
Enhanced Care as Usual ConditionPatient Activation Measure (PAM-13)14-week follow-up assessment70.12 score on a scale
Primary

Self-efficacy Via the General Self-Efficacy Scale

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

Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments

Population: Intent-to-Treat (ITT) sample

ArmMeasureGroupValue (MEAN)
RISESelf-efficacy Via the General Self-Efficacy ScaleBaseline28.7 score on a scale
RISESelf-efficacy Via the General Self-Efficacy Scale10-Week Follow-up33.33 score on a scale
RISESelf-efficacy Via the General Self-Efficacy Scale14-Week Follow-up34.07 score on a scale
Enhanced Care as Usual ConditionSelf-efficacy Via the General Self-Efficacy ScaleBaseline29.90 score on a scale
Enhanced Care as Usual ConditionSelf-efficacy Via the General Self-Efficacy Scale10-Week Follow-up30.66 score on a scale
Enhanced Care as Usual ConditionSelf-efficacy Via the General Self-Efficacy Scale14-Week Follow-up30.52 score on a scale
Comparison: Comparison of groups on self-efficacy via the General Self-Efficacy Scalep-value: <0.05Mixed Models Analysis
Primary

Valued Living Questionnaire

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)

Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments

Population: Intent-to-Treat (ITT) sample

ArmMeasureGroupValue (MEAN)
RISEValued Living QuestionnaireBaseline49.88 score on a scale
RISEValued Living Questionnaire10-Week Follow-up63.27 score on a scale
RISEValued Living Questionnaire14-Week Follow-Up60.96 score on a scale
Enhanced Care as Usual ConditionValued Living QuestionnaireBaseline48.88 score on a scale
Enhanced Care as Usual ConditionValued Living Questionnaire10-Week Follow-up53.44 score on a scale
Enhanced Care as Usual ConditionValued Living Questionnaire14-Week Follow-Up57.23 score on a scale
Secondary

Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.

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).

Time frame: Assessed at 10-week follow-up or 14-week follow-up, values at the end of 14 weeks reported

Population: 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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
RISEBrief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.'Somewhat helpful'6 Participants
RISEBrief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.'Somewhat unhelpful'0 Participants
RISEBrief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.'Neither helpful or unhelpful'0 Participants
RISEBrief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.'Highly unhelpful'0 Participants
RISEBrief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.'Highly helpful'23 Participants
Enhanced Care as Usual ConditionBrief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.'Highly unhelpful'0 Participants
Enhanced Care as Usual ConditionBrief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.'Highly helpful'16 Participants
Enhanced Care as Usual ConditionBrief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.'Somewhat helpful'14 Participants
Enhanced Care as Usual ConditionBrief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.'Neither helpful or unhelpful'0 Participants
Enhanced Care as Usual ConditionBrief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.'Somewhat unhelpful'0 Participants
Secondary

Center for Epidemiological Studies-Depression Scale

Measures change in depressive symptoms; This measure ranges from 0-60; higher scores reflect (worse) higher levels of symptoms

Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments

Population: Intent-to-treat (ITT) sample

ArmMeasureGroupValue (MEAN)
RISECenter for Epidemiological Studies-Depression ScaleBaseline27.21 score on a scale
RISECenter for Epidemiological Studies-Depression Scale10-week follow-up19.59 score on a scale
RISECenter for Epidemiological Studies-Depression Scale14-week follow-up21.12 score on a scale
Enhanced Care as Usual ConditionCenter for Epidemiological Studies-Depression ScaleBaseline24.50 score on a scale
Enhanced Care as Usual ConditionCenter for Epidemiological Studies-Depression Scale10-week follow-up22.76 score on a scale
Enhanced Care as Usual ConditionCenter for Epidemiological Studies-Depression Scale14-week follow-up19.72 score on a scale
Secondary

Client Services Questionnaire (CSQ-8)

Measures satisfaction with treatment; Scores range from 8 to 32; higher scores reflect higher satisfaction with treatment (i.e., a better outcome)

Time frame: 10-week follow-up assessment

Population: Intent-to-Treat (ITT) Sample

ArmMeasureValue (MEAN)Dispersion
RISEClient Services Questionnaire (CSQ-8)29.30 score on a scaleStandard Deviation 2.78
Enhanced Care as Usual ConditionClient Services Questionnaire (CSQ-8)25.07 score on a scaleStandard Deviation 4.85
Secondary

Conflict Tactic Scales Revised

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).

Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments

Population: ITT sample

ArmMeasureGroupValue (MEAN)
RISEConflict Tactic Scales RevisedBaseline11.17 units on a scale (count scores)
RISEConflict Tactic Scales Revised10-Week Follow-up3.37 units on a scale (count scores)
RISEConflict Tactic Scales Revised14-Week Follow-up3.34 units on a scale (count scores)
Enhanced Care as Usual ConditionConflict Tactic Scales RevisedBaseline11.67 units on a scale (count scores)
Enhanced Care as Usual ConditionConflict Tactic Scales Revised10-Week Follow-up4.93 units on a scale (count scores)
Enhanced Care as Usual ConditionConflict Tactic Scales Revised14-Week Follow-up2.8 units on a scale (count scores)
Secondary

Connor-Davidson Resilience Scale

Measures patient resilience; Scores range from 0-100,with higher scores reflecting higher resilience

Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments

Population: Intent-to-treat (ITT) sample

ArmMeasureGroupValue (MEAN)
RISEConnor-Davidson Resilience ScaleBaseline25.43 score on a scale
RISEConnor-Davidson Resilience Scale10-Week Follow-Up29.67 score on a scale
RISEConnor-Davidson Resilience Scale14-Week Follow-Up29.65 score on a scale
Enhanced Care as Usual ConditionConnor-Davidson Resilience ScaleBaseline24.1 score on a scale
Enhanced Care as Usual ConditionConnor-Davidson Resilience Scale10-Week Follow-Up26 score on a scale
Enhanced Care as Usual ConditionConnor-Davidson Resilience Scale14-Week Follow-Up26.07 score on a scale
Secondary

Coping Strategies Inventory - Short Form

Measures engagement coping skills; Scores range from 8-40, with higher score reflecting better coping

Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments

Population: Intent-to-treat (ITT) sample

ArmMeasureGroupValue (MEAN)
RISECoping Strategies Inventory - Short FormBaseline26.42 mean score on a scale
RISECoping Strategies Inventory - Short Form10-Week Follow-Up27.30 mean score on a scale
RISECoping Strategies Inventory - Short Form14-Week Follow-Up26.92 mean score on a scale
Enhanced Care as Usual ConditionCoping Strategies Inventory - Short FormBaseline25.69 mean score on a scale
Enhanced Care as Usual ConditionCoping Strategies Inventory - Short Form10-Week Follow-Up25.74 mean score on a scale
Enhanced Care as Usual ConditionCoping Strategies Inventory - Short Form14-Week Follow-Up25.4 mean score on a scale
Secondary

Depression Anxiety Stress Scale- Anxiety Subscale

Measures anxiety symptom severity; Scores range from 0-42, with higher scores indicating higher levels of anxiety.

Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments

Population: Intent-to-treat (ITT) sample

ArmMeasureGroupValue (MEAN)
RISEDepression Anxiety Stress Scale- Anxiety SubscaleBaseline25.11 score on a scale
RISEDepression Anxiety Stress Scale- Anxiety Subscale10-Week Follow-Up22.67 score on a scale
RISEDepression Anxiety Stress Scale- Anxiety Subscale14-Week Follow-Up23.58 score on a scale
Enhanced Care as Usual ConditionDepression Anxiety Stress Scale- Anxiety SubscaleBaseline23.4 score on a scale
Enhanced Care as Usual ConditionDepression Anxiety Stress Scale- Anxiety Subscale10-Week Follow-Up22.98 score on a scale
Enhanced Care as Usual ConditionDepression Anxiety Stress Scale- Anxiety Subscale14-Week Follow-Up21.22 score on a scale
Secondary

Patient Health Questionnaire

Measures change in somatic and physical health symptoms; score ranges from 0 to 30, with higher scores representing higher levels of physical health problems

Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments

Population: Intent-to-treat (ITT) sample

ArmMeasureGroupValue (MEAN)
RISEPatient Health Questionnaire10-Week Follow-Up11.37 score on a scale
RISEPatient Health QuestionnaireBaseline12.52 score on a scale
RISEPatient Health Questionnaire14-Week Follow-Up11.42 score on a scale
Enhanced Care as Usual ConditionPatient Health QuestionnaireBaseline10.60 score on a scale
Enhanced Care as Usual ConditionPatient Health Questionnaire10-Week Follow-Up12.01 score on a scale
Enhanced Care as Usual ConditionPatient Health Questionnaire14-Week Follow-Up9.69 score on a scale
Secondary

Physical, Mental and Social Service Care Use

Measures overall number of VA and non-VA health care visits (inclusive of physical, mental health, and social service use visits).

Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments

Population: Intent-to-treat (ITT) sample

ArmMeasureGroupValue (MEAN)
RISEPhysical, Mental and Social Service Care UseBaseline8.27 visits
RISEPhysical, Mental and Social Service Care Use10-Week Follow-Up6.15 visits
RISEPhysical, Mental and Social Service Care Use14-Week Follow-Up4.62 visits
Enhanced Care as Usual ConditionPhysical, Mental and Social Service Care UseBaseline7.03 visits
Enhanced Care as Usual ConditionPhysical, Mental and Social Service Care Use10-Week Follow-Up6.24 visits
Enhanced Care as Usual ConditionPhysical, Mental and Social Service Care Use14-Week Follow-Up4.93 visits
Secondary

PTSD Checklist for DSM-5

Measures change in DSM-5 PTSD symptom severity. Scores range from 0-80; higher scores reflect higher/worse PTSD symptoms.

Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments

Population: Intent-to-Treat (ITT) Sample

ArmMeasureGroupValue (MEAN)
RISEPTSD Checklist for DSM-5Baseline41.92 score on a scale
RISEPTSD Checklist for DSM-510-week assessment29.97 score on a scale
RISEPTSD Checklist for DSM-514-week assessment32.73 score on a scale
Enhanced Care as Usual ConditionPTSD Checklist for DSM-5Baseline39.97 score on a scale
Enhanced Care as Usual ConditionPTSD Checklist for DSM-510-week assessment36.97 score on a scale
Enhanced Care as Usual ConditionPTSD Checklist for DSM-514-week assessment32.13 score on a scale
Secondary

Safety Behaviors Checklist

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.

Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments

Population: Intent-to-treat (ITT) sample

ArmMeasureGroupValue (MEAN)
RISESafety Behaviors ChecklistBaseline12.87 score on a scale
RISESafety Behaviors Checklist10-Week Follow-Up13.04 score on a scale
RISESafety Behaviors Checklist14-Week Follow-Up9.4 score on a scale
Enhanced Care as Usual ConditionSafety Behaviors ChecklistBaseline12.94 score on a scale
Enhanced Care as Usual ConditionSafety Behaviors Checklist10-Week Follow-Up12.39 score on a scale
Enhanced Care as Usual ConditionSafety Behaviors Checklist14-Week Follow-Up12.34 score on a scale
Secondary

SF-12 Health Survey

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).

Time frame: Baseline, 10-Week follow-up, and 14-Week follow-up Assessments

Population: Intent-to-treat (ITT) sample

ArmMeasureGroupValue (MEDIAN)Dispersion
RISESF-12 Health SurveyBaseline3 score on a scaleStandard Deviation 0.87
RISESF-12 Health Survey10-Week Follow-Up3 score on a scaleStandard Deviation 0.87
RISESF-12 Health Survey14-Week Follow-Up3 score on a scaleStandard Deviation 0.76
Enhanced Care as Usual ConditionSF-12 Health SurveyBaseline3 score on a scaleStandard Deviation 0.77
Enhanced Care as Usual ConditionSF-12 Health Survey10-Week Follow-Up2 score on a scaleStandard Deviation 0.74
Enhanced Care as Usual ConditionSF-12 Health Survey14-Week Follow-Up3 score on a scaleStandard Deviation 0.87

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026