Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03261700
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03261700
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : August 13, 2020
Sponsor:
Collaborator:
VA Boston Healthcare System
Information provided by (Responsible Party):
VA Office of Research and Development

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;
  • 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.

Condition or disease Intervention/treatment Phase
Intimate Partner Violence Empowerment Behavioral: RISE Other: Information and referral condition Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: For the RCT (Aim 3), participants will be randomized to RISE or an information and referral condition.
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE): Tailoring and Evaluating a Patient-Centered Counseling Intervention for Women Veterans
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
Experimental: 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, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
Behavioral: 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.
Other Name: Recovering from IPV through Strengths and Empowerment

Active Comparator: Information and referral 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.
Other: 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).
Other Name: Control condition




Primary Outcome Measures :
  1. Empowerment via the Personal Progress Scale Revised [ Time Frame: Change from baselineline empowerment at 10 and 14 weeks ]
    Measures change in sense of personal empowerment

  2. Self-efficacy via the General Self-Efficacy Scale [ Time Frame: Change from baseline self-efficacy at 10 and 14 weeks ]
    This scale is a self-report of change in general self-efficacy

  3. Valued Living Questionnaire [ Time Frame: Change from baseline congruent behaviors at 10 and 14 weeks ]
    Measures change in valued living, and congruence between stated values and past-week valued behavior

  4. Patient Activation Measure [ Time Frame: Change from baseline patient activation at 10 and 14 weeks ]
    Measures change in patient engagement in needed health care


Secondary Outcome Measures :
  1. PTSD Checklist-5 [ Time Frame: Change from baseline PTSD symptoms at 10 and 14 weeks ]
    Measures change in DSM-5 PTSD symptoms

  2. Center for Epidemiological Studies-Depression Scale [ Time Frame: Change from baseline depression symptoms at 10 and 14 weeks ]
    Measures change in depressive symptoms

  3. SF-12 Health Survey [ Time Frame: Change from baseline physical-health related quality of life at 10 and 14 weeks ]
    Measures change in physical-health related quality of life

  4. Conflict Tactic Scales Revised [ Time Frame: Change from baseline IPV at 10 and 14 weeks ]
    Measures change in physical, sexual, and psychological IPV

  5. Physical, Mental and Social Service Care Use [ Time Frame: Change from baseline VA and non-VA health care and social service use at 10 and 14 weeks ]
    Measures change in VA and non-VA physical and mental health use and social service use

  6. Client Services Questionnaire [ Time Frame: 10 weeks ]
    Measures acceptability of treatment

  7. Patient Health Questionnaire [ Time Frame: Change from baseline somatic and physical health symtpoms at 10 and 14 weeks ]
    Measures change in somatic and physical health symptoms

  8. Safety Behaviors Checklist [ Time Frame: Change from baseline safety behavior use at 10 and 14 weeks ]
    Measures change in patients' behaviors to safeguard themselves against IPV

  9. Connor-Davidson Resilience Scale [ Time Frame: Change from baseline resilience at 10 and 14 weeks ]
    Measures change in patient resilience

  10. Depression Anxiety Stress Scale- Anxiety Subscale [ Time Frame: Change from baseline anxiety at 10 and 14 weeks ]
    Measures change in anxiety symtpoms

  11. Coping Strategies Inventory - Short Form [ Time Frame: Change from baseline coping skills at 10 and 14 weeks ]
    Measures engagement and disengagement coping skills

  12. Brief semi-structured interview to assess acceptability and feasibility of the intervention [ Time Frame: 10 and 14 weeks ]
    Semi-structured interview questions developed for the purpose of this study assess participants' perceptions of the intervention, including acceptability and feasibility, as well as barriers to treatment engagement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identify as female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261700


Contacts
Layout table for location contacts
Contact: Katherine M Iverson, PhD MA BA (857) 364-2066 Katherine.Iverson@va.gov
Contact: Sara B Danitz, PhD (857) 364-6854 Sara.Danitz@va.gov

Locations
Layout table for location information
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Katherine M Iverson, PhD MA BA    857-364-2066    Katherine.Iverson@va.gov   
Contact: Sara B Danitz, PhD    (857) 364-6854    Sara.Danitz@va.gov   
Principal Investigator: Katherine M. Iverson, PhD MA BA         
Sponsors and Collaborators
VA Office of Research and Development
VA Boston Healthcare System
Investigators
Layout table for investigator information
Principal Investigator: Katherine M. Iverson, PhD MA BA VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Publications:
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03261700    
Other Study ID Numbers: IIR 16-062
1I01HX002178-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
women Veterans
interpersonal violence