NCT05011552

Brief Summary

Intimate partner violence (IPV) is a serious social and public health issue. In the U.S., more than 1 in 3 women experience physical or sexual violence, and/or stalking by an intimate partner during their lifetime. IPV has significant physical and mental health consequences such as injury, chronic pain, and depression. Chinese immigrants have been overlooked and underserved and represent an especially vulnerable group of IPV victims, as they are less likely to seek help through IPV service agencies, women's shelters, hospitals, or law enforcement. Effective IPV intervention programs that are culturally appropriate, accessible, and acceptable are essential to this underserved population. However, no studies have been conducted with abused Chinese immigrant women to help them deal with IPV and reduce mental health consequences. Therefore, the study adapted a structured IPV intervention from the Domestic Violence Enhanced Home Visitation Program (DOVE) as well as incorporate self-compassion and relaxation techniques for Chinese immigrant women experiencing IPV. The intervention is called Self-Compassion, Health, and Empowerment (SHE). The study will test the feasibility and acceptability of the SHE to reduce IPV and improve mental health well-being for abused Chinese immigrant women residing in the US.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

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 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

August 10, 2021

Last Update Submit

April 14, 2023

Conditions

Intimate Partner ViolenceDepressionAnxietyPTSD

Outcome Measures

Primary Outcomes (12)

  • Intimate Partner Violence

    The Revised Conflict Tactics Scales (CTS2)

    It will be assessed at baseline before the start of the 8-week intervention.

  • Intimate Partner Violence

    The Revised Conflict Tactics Scales (CTS2)

    It will be assessed immediately after the 8-week intervention.

  • Intimate Partner Violence

    The Revised Conflict Tactics Scales (CTS2)

    It will be assessed 2 months after the 8-week intervention.

  • Depression

    The Patient Health Questionnaire-9 (PHQ-9)

    It will be assessed at baseline before the start of the 8-week intervention.

  • Depression

    The Patient Health Questionnaire-9 (PHQ-9)

    It will be assessed immediately after the 8-week intervention.

  • Depression

    The Patient Health Questionnaire-9 (PHQ-9)

    It will be assessed 2 months after the 8-week intervention.

  • Anxiety

    The Generalized Anxiety Disorder-7 (GAD-7)

    It will be assessed at baseline before the start of the 8-week intervention.

  • Anxiety

    The Generalized Anxiety Disorder-7 (GAD-7)

    It will be assessed immediately after the 8-week intervention.

  • Anxiety

    The Generalized Anxiety Disorder-7 (GAD-7)

    It will be assessed 2 months after the 8-week intervention.

  • Posttraumatic Stress Disorder (PTSD)

    The PTSD Checklist for DSM-5 (PCL-5)

    It will be assessed at baseline before the start of the 8-week intervention.

  • Posttraumatic Stress Disorder (PTSD)

    The PTSD Checklist for DSM-5 (PCL-5)

    It will be assessed immediately after the 8-week intervention.

  • Posttraumatic Stress Disorder (PTSD)

    The PTSD Checklist for DSM-5 (PCL-5)

    It will be assessed 2 months after the 8-week intervention.

Secondary Outcomes (6)

  • Number of Safety Behaviors Taken by Participants

    It will be assessed at baseline before the start of the 8-week intervention.

  • Number of Safety Behaviors Taken by Participants

    It will be assessed immediately after the 8-week intervention.

  • Number of Safety Behaviors Taken by Participants

    It will be assessed 2 months after the 8-week intervention.

  • Self-Compassion

    It will be assessed at baseline before the start of the 8-week intervention.

  • Self-Compassion

    It will be assessed immediately after the 8-week intervention.

  • +1 more secondary outcomes

Study Arms (2)

The intervention group

EXPERIMENTAL
Behavioral: Self-Compassion, Health, and Empowerment (SHE)

The control group

PLACEBO COMPARATOR
Behavioral: The Control Condition

Interventions

Self-Compassion, Health, and Empowerment (SHE)BEHAVIORAL

The SHE intervention includes 8 weekly sessions and 24-hour access to the intervener for any additional support needed. The first and last sessions will be delivered over the phone with the woman based on a brochure. The brochure describes the four major components: a) IPV information, b) Danger Assessment, c) Safety Planning, and d) Resources. It will be discussed with the woman in an interactive manner so that the woman is encouraged to describe her experiences and choose her options as they proceed. Session 2-7 focus on providing mental health self-care resources, which are deep breathing, progressive muscle relaxation, visualization, general introduction and overview of self-compassion, mindfulness, and loving-kindness.

The intervention group
The Control ConditionBEHAVIORAL

Women randomized to the control group will be provided with the same brochure and mental health care resources.

The control group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older and female, self-identify as Chinese, reside in the U.S., have been in an intimate relationship at time of participation, and have experienced IPV within the current relationship.

You may not qualify if:

  • Women are excluded if they report substance use or suicidality or having been in mental health care for severe mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas At Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

  • Li Y, Rhee H, Bullock LFC, McCaw B, Bloom T. Self-Compassion, Health, and Empowerment: A Pilot Randomized Controlled Trial for Chinese Immigrant Women Experiencing Intimate Partner Violence. J Interpers Violence. 2024 Apr;39(7-8):1571-1595. doi: 10.1177/08862605231207624. Epub 2023 Oct 30.

    PMID: 37902465DERIVED

MeSH Terms

Conditions

DepressionAnxiety DisordersStress Disorders, Post-Traumatic

Interventions

Health

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 10, 2021

First Posted

August 18, 2021

Study Start

March 1, 2022

Primary Completion

March 3, 2023

Study Completion

March 3, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

US(1)