NCT07733531

Brief Summary

Intimate partner violence (IPV) can have serious and lasting effects on women's mental health and well-being. Chinese immigrant women in the United States often face additional barriers to obtaining IPV and mental health support, including language, cultural, and social challenges. There is a need for culturally appropriate interventions that improve access to care and address the mental health needs of this underserved population. The purpose of this study is to evaluate the efficacy of the Self-Compassion, Health, and Empowerment (SHE) intervention, a culturally tailored mobile health (mHealth) program designed for Chinese immigrant women experiencing IPV. Participants will be randomly assigned to either the SHE intervention or an attention control program and will complete study assessments over a 12-month follow-up period. The results of this study will help determine whether the SHE intervention improves mental health and well-being among Chinese immigrant women experiencing IPV and may provide evidence for an accessible, culturally appropriate intervention that can be implemented more broadly.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
364

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2030

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

4 years

First QC Date

July 24, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

EmpowermentSelf-compassionmindfulnesssafety

Outcome Measures

Primary Outcomes (3)

  • Depression symptoms

    The instrument used will be the Patient Health Questionnaire-9. The total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.

    Baseline and 6-week, 3-month, 6-month, and 12-month follow-ups

  • Anxiety symptoms

    The instrument used will be the Generalized Anxiety Disorder-7. The total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.

    Baseline and 6-week, 3-month, 6-month, and 12-month follow-ups

  • Symptoms of post-traumatic stress disorder (PTSD)

    The instrument used will be the PTSD Checklist for DSM-5. The total scores range from 0 to 80, with higher scores indicating more severe PTSD symptoms.

    Baseline and 6-week, 3-month, 6-month, and 12-month follow-ups

Secondary Outcomes (1)

  • Intimate partner violence

    Baseline and 6-week, 3-month, 6-month, and 12-month follow-ups

Study Arms (2)

The SHE intervention group

EXPERIMENTAL

The intervention will consist of 6 weekly sessions. Session 1 is a phone discussion about an IPV safety brochure covering IPV information, questions from the Danger Assessment, safety planning, options, and available resources. It also includes immigrant-specific content such as immigration-related abuse, legal options for immigrants, and resources for immigrant survivors. Sessions 2-6 will focus on providing mental health self-care resources, with a specific topic assigned each week (Deep Breathing, Progressive Muscle Relaxation, Mindful Self- Compassion, Mindfulness, and Loving-Kindness). Each session includes a video introduction on 1 of our 5 topics, with accompanying audio instructions for exercises. The interventionist will guide participants to review the video at the beginning of each session and encourage them to practice the exercises presented in that session daily for 1 week.

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

The attention control group

ACTIVE COMPARATOR

Participants in the attention control group will receive six weekly educational sessions on nutrition and health, matched in delivery mode, timing, and frequency of contacts with the intervention group.

Behavioral: Health and Nutrition Program

Interventions

The intervention will consist of 6 weekly sessions. Session 1 is a phone discussion about an IPV safety brochure covering IPV information, questions from the Danger Assessment, safety planning, options, and available resources. It also includes immigrant-specific content such as immigration-related abuse, legal options for immigrants, and resources for immigrant survivors. Sessions 2-6 will focus on providing mental health self-care resources, with a specific topic assigned each week (Deep Breathing, Progressive Muscle Relaxation, Mindful Self- Compassion, Mindfulness, and Loving-Kindness). Each session includes a video introduction on 1 of our 5 topics, with accompanying audio instructions for exercises. The interventionist will guide participants to review the video at the beginning of each session and encourage them to practice the exercises presented in that session daily for 1 week.

The SHE intervention group

It consists of six weekly educational sessions focused on nutrition and health. Each week, participants will view a video on a specific nutrition-related topic and complete a quiz/homework (e.g., food label identification, healthy meal planning). Reminder and check-in messages will be sent every other day via text messages to reinforce the content and respond to any participant questions.

The attention control group

Eligibility Criteria

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

You may qualify if:

  • Age 18 or older;
  • Self-identify as a woman;
  • Self-identify as Chinese;
  • Reside in the U.S.;
  • Self-report experiences of any physical, emotional, or sexual violence from an intimate partner within the past year;
  • Self-report symptoms of depression, anxiety, or post-traumatic stress disorder (PTSD).

You may not qualify if:

  • Those who cannot speak or understand Mandarin or English;
  • Those with substance use, suicidality, or who have 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

MeSH Terms

Conditions

Combat DisordersEmpowerment

Interventions

HealthMethods

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Population CharacteristicsInvestigative Techniques

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The data analyst will be masked.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 29, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2030

Study Completion (Estimated)

August 31, 2030

Last Updated

July 30, 2026

Record last verified: 2026-07

Locations