Self-Compassion, Health, and Empowerment
SHE RCT
2 other identifiers
interventional
364
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
Longer than P75 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
July 29, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2030
Study Completion
Last participant's last visit for all outcomes
August 31, 2030
July 30, 2026
July 1, 2026
4 years
July 24, 2026
July 28, 2026
Conditions
Keywords
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
EXPERIMENTALThe 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 attention control group
ACTIVE COMPARATORParticipants 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.
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.
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.
Eligibility Criteria
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
- Yang Lilead
Study Sites (1)
The University of Texas at Austin
Austin, Texas, 78712, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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