NCT03261700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 22, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 30, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

August 17, 2017

Results QC Date

December 1, 2021

Last Update Submit

July 26, 2023

Conditions

Keywords

women Veteransinterpersonal violence

Outcome Measures

Primary Outcomes (4)

  • 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

    Baseline,10-week follow-up, and 14-week follow-up assessments

  • 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

    Baseline, 10-week follow-up, and 14-week follow-up assessments

  • 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)

    Baseline, 10-week follow-up, and 14-week follow-up assessments

  • 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.

    Baseline, 10-week follow-up, and 14-week follow-up assessments

Secondary Outcomes (12)

  • PTSD Checklist for DSM-5

    Baseline, 10-week follow-up, and 14-week follow-up assessments

  • Center for Epidemiological Studies-Depression Scale

    Baseline, 10-week follow-up, and 14-week follow-up assessments

  • SF-12 Health Survey

    Baseline, 10-Week follow-up, and 14-Week follow-up Assessments

  • Conflict Tactic Scales Revised

    Baseline, 10-week follow-up, and 14-week follow-up assessments

  • Physical, Mental and Social Service Care Use

    Baseline, 10-week follow-up, and 14-week follow-up assessments

  • +7 more secondary outcomes

Study Arms (2)

RISE

EXPERIMENTAL

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

Information and referral condition

ACTIVE COMPARATOR

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

Interventions

RISEBEHAVIORAL

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.

Also known as: Recovering from IPV through Strengths and Empowerment
RISE

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).

Also known as: Control condition
Information and referral condition

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identify as female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

Related Publications (10)

  • Dardis CM, Dichter ME, Iverson KM. Empowerment, PTSD and revictimization among women who have experienced intimate partner violence. Psychiatry Res. 2018 Aug;266:103-110. doi: 10.1016/j.psychres.2018.05.034. Epub 2018 May 30.

    PMID: 29859496BACKGROUND
  • Grillo AR, Danitz SB, Dichter ME, Driscoll MA, Gerber MR, Hamilton AB, Wiltsey-Stirman S, Iverson KM. Strides Toward Recovery From Intimate Partner Violence: Elucidating Patient-Centered Outcomes to Optimize a Brief Counseling Intervention for Women. J Interpers Violence. 2021 Aug;36(15-16):NP8431-NP8453. doi: 10.1177/0886260519840408. Epub 2019 Apr 17.

    PMID: 30994401BACKGROUND
  • Iverson KM, Dardis CM, Grillo AR, Galovski TE, Pogoda TK. Associations between traumatic brain injury from intimate partner violence and future psychosocial health risks in women. Compr Psychiatry. 2019 Jul;92:13-21. doi: 10.1016/j.comppsych.2019.05.001. Epub 2019 May 14.

    PMID: 31203176BACKGROUND
  • Danitz SB, Stirman SW, Grillo AR, Dichter ME, Driscoll M, Gerber MR, Gregor K, Hamilton AB, Iverson KM. When user-centered design meets implementation science: integrating provider perspectives in the development of an intimate partner violence intervention for women treated in the United States' largest integrated healthcare system. BMC Womens Health. 2019 Nov 27;19(1):145. doi: 10.1186/s12905-019-0837-8.

    PMID: 31771557BACKGROUND
  • Iverson KM, Danitz SB, Driscoll M, Vogt D, Hamilton AB, Gerber MR, Wiltsey Stirman S, Shayani DR, Suvak MK, Dichter ME. Recovering from intimate partner violence through Strengths and Empowerment (RISE): Development, pilot testing, and refinement of a patient-centered brief counseling intervention for women. Psychol Serv. 2022;19(Suppl 2):102-112. doi: 10.1037/ser0000544. Epub 2021 Jun 10.

    PMID: 34110870BACKGROUND
  • Iverson KM, Danitz SB, Shayani DR, Vogt D, Stirman SW, Hamilton AB, Mahoney CT, Gerber MR, Dichter ME. Recovering From Intimate Partner Violence Through Strengths and Empowerment: Findings From a Randomized Clinical Trial. J Clin Psychiatry. 2021 Nov 23;83(1):21m14041. doi: 10.4088/JCP.21m14041.

  • Shayani DR, Danitz SB, Low SK, Hamilton AB, Iverson KM. Women Tell All: A Comparative Thematic Analysis of Women's Perspectives on Two Brief Counseling Interventions for Intimate Partner Violence. Int J Environ Res Public Health. 2022 Feb 22;19(5):2513. doi: 10.3390/ijerph19052513.

  • Davin KR, Dardis CM, Barth MR, Iverson KM. Prospective mental health effects of intimate partner stalking among women veterans. Psychol Trauma. 2022 Jul;14(5):751-758. doi: 10.1037/tra0001144. Epub 2021 Nov 4.

  • Iverson KM, Dardis CM, Cowlishaw S, Webermann AR, Shayani DR, Dichter ME, Mitchell KS, Mattocks KM, Gerber MR, Portnoy GR. Effects of Intimate Partner Violence During COVID-19 and Pandemic-Related Stress on the Mental and Physical Health of Women Veterans. J Gen Intern Med. 2022 Sep;37(Suppl 3):724-733. doi: 10.1007/s11606-022-07589-z. Epub 2022 Aug 30.

  • Webermann AR, Dardis CM, Iverson KM. The role of general self-efficacy in intimate partner violence and symptoms of posttraumatic stress disorder among women veterans. J Trauma Stress. 2022 Jun;35(3):868-878. doi: 10.1002/jts.22794. Epub 2022 Jan 31.

Results Point of Contact

Title
Dr. Katherine Iverson, PI
Organization
National Center for PTSD, located at the VA Boston Healthcare System

Study Officials

  • Katherine M. Iverson, PhD MA BA

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open label
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: For the RCT (Aim 3), participants will be randomized to RISE or an information and referral condition.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 25, 2017

Study Start

October 22, 2018

Primary Completion

November 23, 2020

Study Completion

November 23, 2020

Last Updated

July 27, 2023

Results First Posted

March 30, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations