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

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ClinicalTrials.gov Identifier: NCT03261700
Recruitment Status : Not yet recruiting
First Posted : August 25, 2017
Last Update Posted : June 28, 2018
Sponsor:
Collaborators:
VA Boston Healthcare System
VA Connecticut 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 Phase 1

  Show Detailed Description

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
Estimated Study Start Date : October 22, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

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, 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, 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
Participants randomized to this arm will receive information about IPV and referrals to VA and community resources.
Other: Information and referral condition
Participants randomized to this arm will receive information about IPV and referrals to VA and community resources.
Other Name: Control condition




Primary Outcome Measures :
  1. Empowerment via the Personal Progress Scale Revised [ Time Frame: Change from baselineline empowerment at 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 14 weeks ]
    This scale is a self-report of change in general self-efficacy

  3. Patient activation via the Patient Activation Measure-13 [ Time Frame: Change from baseline patient activation at 14 weeks ]
    Measures change in patient knowledge, skill, and confidence for self-management


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

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

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

  4. Conflict Tactic Scales Revised [ Time Frame: Change from baseline IPV at 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 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



Information from the National Library of Medicine

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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 female
  • Are at least 18 years of age
  • A patient at VA Boston Healthcare System or VA Connecticut Healthcare System
  • Self- reported that they have experienced past-year physical, sexual, or psychological IPV
  • Ability to understand study procedures in English
  • 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
Contact: Katherine M Iverson, PhD MA BA (857) 364-2066 Katherine.Iverson@va.gov
Contact: Mary Driscoll, PhD (203) 932-5744 ext 3631 Mary.Driscoll3@va.gov

Locations
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Not yet recruiting
Boston, Massachusetts, United States, 02130
Contact: Katherine M Iverson, PhD MA BA    857-364-2066    Katherine.Iverson@va.gov   
Contact: Mary Driscoll, PhD    (203) 932-5744 ext 3631    Mary.Driscoll3@va.gov   
Principal Investigator: Katherine M. Iverson, PhD MA BA         
Sponsors and Collaborators
VA Office of Research and Development
VA Boston Healthcare System
VA Connecticut Healthcare System
Investigators
Principal Investigator: Katherine M. Iverson, PhD MA BA VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Publications of Results:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03261700     History of Changes
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: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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