Skip to main content
OpenTrials
Completed

NCT Number: NCT03573778

IHEAL Trial: Effectiveness of a Health Promotion Intervention for Women Who Have Experienced Intimate Partner Violence

Living with an abusive partner has many negative impacts on women's health, safety and the quality of their lives. These issues often continue when women separate, or take steps to separate, from an abusive partner, and can make it more difficult to create a new life. However, few supports are available to help women manage their health and other challenges around the time of separation.

The Intervention for Health Enhancement and Living (iHEAL) was specifically developed to support women at this time. In iHEAL, women work with a Registered Nurse on issues that affect that their health and well-being in 10 and 18 visits that take place in a safe, private location over a 6 month period. The woman decides which issues she would like to work on, with nurses providing personalized help and support that fits with the woman's needs, goals and wishes. This includes helping her connect to local services if she chooses.

The purpose of this study is to learn whether iHEAL can improve the health and quality of life of women who have separated, or are taking steps to separate, from an abusive partner. To do this, 280 Canadian women from 3 provinces will be offered either iHEAL nurse visits or information about community services that they can use on their own. All participants will complete online surveys when they first start the study and 6 12, and 18 months later to examine whether there are changes in their health, quality of life, confidence and/or control. We also want to learn whether iHEAL is more helpful for some groups of women and whether any benefits to women that are identified outweigh the costs of providing the intervention. A small group of ~30-40 women will be asked to take part in an interview about what is was like to take part in this study when they complete the trial so that we can learn how to further improve iHEAL.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intimate Partner Violence

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

For a detailed description of the study rationale, hypotheses, research questions and methods, please see:

Ford-Gilboe, M., Varcoe, C., Scott-Storey, K. et al. Longitudinal effectiveness of a woman-led, nurse delivered health promotion intervention for women who have experienced intimate partner violence: iHEAL randomized controlled trial. BMC Public Health 24, 398 (2024). https://doi.org/10.1186/s12889-023-17578-4.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Woman
  • 19 years of age or older
  • Able to speak, read and understand English
  • Residing in specific communities in Ontario, British Columbia or New Brunswick
  • Planning to remain in area for next 6 months
  • Experienced physical, sexual, and/or psychological abuse, including coercive control from a current or former partner in the previous 12 months
  • Planning to separate OR in the process of separating OR separated from an abusive partner in the previous 3 years
  • Has access to the internet, and a safe computer, tablet, or smart phone
  • Has a safe email address

Exclusion criteria

  • Man
  • Under 19 years of age
  • Cannot read, speak, understand English
  • Living outside of the selected study sites, or living in the area but planning to relocate within 6 months
  • No experience of physical, sexual, or psychological abuse, including coercive control, from a current or former partner in the previous 12 months
  • Planning to stay with an abusive partner OR separated more than 3 years ago
  • No access to the internet, or safe computer, tablet or smart phone
  • No access to safe email and mailing address

Treatment and study plan

iHEAL

Behavioral

Women work with a Registered Nurse in 10-18 visits (over 6 months) that focus on 6 inter-related 6 components (areas): Safeguarding, Managing Symptoms, Getting Basics, Cautiously Connecting, Regenerating Family, Renewing Self. Using a standard 3 phase process, and guided by 5 principles, the nurse discusses each of these components with the woman in order to identify the woman's needs, experiences and priorities. The nurse then provides personalized support to assist the woman in address the concerns that she sees as most important for her health and well-being; this support includes linking women to existing services if she chooses.

Information about Community Services

Behavioral

Women are provided with information about community services appropriate for women experiencing intimate partner violence and consistent with what service providers might recommend (usual care). Women are encouraged to use this information as they see fit.

Primary outcomes

  1. Changes in Quality of Life on the Quality of Life Scale (Sullivan)

    Time frame: baseline, 6 months

    9 item self-report measure developed to assess quality of life across domains important to women who have experienced intimate partner violence. Total scores range from 9 to 63. Higher scores reflect higher levels of quality of life.

  2. Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)

    Time frame: baseline, 6 months

    17 item self-report measure of PTSD symptoms designed for use in community samples and to assess probability of meeting diagnostic criteria for PTSD.

Secondary outcomes

  1. Changes in Quality of Life on the Quality of Life Scale (Sullivan)

    Time frame: baseline, 12 months

    9 item self-report measure developed to assess quality of life across domains important to women who have experienced intimate partner violence

  2. Changes in Quality of Life on the Quality of Life Scale (Sullivan)

    Time frame: Baseline, 18 months

    9 item self-report measure developed to assess quality of life across domains important to women who have experienced intimate partner violence

  3. Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)

    Time frame: Baseline, 12 months

    17 item self-report measure of PTSD symptoms designed for use in community samples and to assess probability of meeting diagnostic criteria for PTSD

  4. Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)

    Time frame: Baseline, 18 months

    17 item self-report measure of PTSD symptoms designed for use in community samples and to assess probability of meeting diagnostic criteria for PTSD

  5. Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised (CESD-R).

    Time frame: Baseline, 6 months

    20 item self-report measure of depressive symptoms in community samples, including probability of meeting criteria for major depressive disorder. Total scores range from 0 to 60. Higher scores reflect higher levels of depressive symptoms.

  6. Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised

    Time frame: Baseline, 12 months

    20 item self-report measure of depressive symptoms in community samples, including probability of meeting criteria for major depressive disorder

  7. Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised

    Time frame: Baseline, 18 months

    20 item self-report measure of depressive symptoms in community samples, including probability of meeting criteria for major depressive disorder

  8. Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)

    Time frame: Baseline, 6 months

    7 item self-report measure of chronic pain intensity and disability, including 4 "grades" that capture level of disability (from no to high)

  9. Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)

    Time frame: Baseline, 12 months

    7 item self-report measure of chronic pain intensity and disability, including 4 "grades" that capture level of disability (from no to high)

  10. Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)

    Time frame: Baseline, 18 months

    7 item self-report measure of chronic pain intensity and disability, including 4 "grades" that capture level of disability (from no to high)

  11. Changes in Personal Control on the Personal Agency Scale (Smith)

    Time frame: Baseline, 6 months

    8 item self-report scale that measures an individual's sense of control and efforts to act on their own behalf. Total scores range from 8 to 32. Higher scores reflect higher levels of personal agency.

  12. Changes in Personal Control on the Personal Agency Scale (Smith)

    Time frame: Baseline, 12 months

    8 item self-report scale that measures an individual's sense of control and efforts to act on their own behalf. Total scores range from 8 to 32. Higher scores reflect higher levels of personal agency.

  13. Changes in Personal Control on the Personal Agency Scale (Smith)

    Time frame: Baseline, 18 months

    8 item self-report scale that measures an individual's sense of control and efforts to act on their own behalf. Total scores range from 8 to 32. Higher scores reflect higher levels of personal agency.

  14. Changes in Confidence (self-efficacy) on investigator-developed scale

    Time frame: Baseline, 6 months

    10 item self-report scale that measures women's confidence in engaging in a set of actions that fit with key goals of the iHEAL on 100 mm visual analogue scales. total scores range from 0 to 100. Higher scores reflect higher levels of confidence.

  15. Changes in Confidence (self-efficacy) on investigator-developed scale

    Time frame: Baseline, 12 months

    10 item self-report scale that measures women's confidence in engaging in a set of actions that fit with key goals of the iHEAL on 100 mm visual analogue scales. Total scores range from 0 to 100. Higher scores reflected higher levels of confidence.

  16. Changes in Confidence (self-efficacy) on investigator-developed scale

    Time frame: Baseline, 18 months

    10 item self-report scale that measures women's confidence in engaging in a set of actions that fit with key goals of the iHEAL on 100 mm visual analogue scales. Total scores range from 0 -100. Higher scores reflect higher levels of confidence.

  17. Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)

    Time frame: Baseline, 6 months

    10 item self-report measure of the intensity of coercive control experienced by women in response to intimate partner violence. Total scores range from 10 to 60. Higher scores reflect higher levels of experiences of coercive control.

  18. Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)

    Time frame: Baseline, 12 months

    10 item self-report measure of the intensity of coercive control experienced by women in response to intimate partner violence. Total scores range from 10 to 60. Higher scores reflect higher levels of experiences of coercive control.

  19. Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)

    Time frame: Baseline, 18 months

    10 item self-report measure of the intensity of coercive control experienced by women in response to intimate partner violence. Total scores range from 10-60. Higher scores reflect higher levels of experiences of coercive control.

Other outcomes

  1. Severity of Intimate Partner Violence on the Composite Abuse Scale Revised - Short Form (CASr-SF)

    Time frame: Baseline, 6, 12, 18 months

    15 item validated measure of severity of intimate partner violence

  2. Problem Drinking on the AUDIT

    Time frame: Baseline, 6, 12, 18 months

    Self-report measure of alcohol mis-use

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Collaborators

  • Johns Hopkins University
  • McMaster University
  • Public Health Agency of Canada (PHAC)
  • University of British Columbia
  • University of New Brunswick
  • Université de Montréal

Registry information

Official study title

iHEAL in Context: Effectiveness of a Health Promotion Intervention for Women Who Have Experienced Intimate Partner Violence (iHEAL Trial)

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jun 29, 2018
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.