Self-Compassion, Health, and Empowerment (SHE RCT)
Self-Compassion, Health, and Empowerment: A Randomized Controlled Trial for Chinese Immigrant Women Experiencing Intimate Partner Violence
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Intimate partner violence (IPV) is a major public health problem that has profound effects on women's physical and mental health. Immigrant women are at increased risk for IPV and often face substantial barriers to accessing support and health services. Chinese immigrants are the largest Asian ethnic group in the United States, yet Chinese immigrant women experiencing IPV remain an underserved population. Cultural stigma, limited English proficiency, immigration-related concerns, social isolation, and limited availability of culturally and linguistically appropriate services contribute to disparities in access to IPV and mental health care.
Mental health problems, including depression, anxiety, and post-traumatic stress disorder (PTSD), are common among women who have experienced IPV. However, few evidence-based interventions have been developed specifically for Chinese immigrant women, and existing services often do not adequately address the cultural and structural barriers that limit access to care.
The Self-Compassion, Health, and Empowerment (SHE) intervention was developed to address these unmet needs. SHE is a culturally tailored, mobile health (mHealth) intervention that combines safety planning and empowerment strategies with self-compassion and relaxation practices to improve psychological well-being. Delivering the intervention remotely through telephone and text messaging is intended to increase accessibility, reduce barriers related to transportation, geography, stigma, and privacy, and facilitate engagement among Chinese immigrant women.
This study is a two-arm randomized controlled trial designed to evaluate the efficacy of the SHE intervention compared with an attention control condition. Participants will be randomly assigned to receive either the SHE intervention or a health education attention control program delivered with the same schedule and frequency of participant contact. The study will evaluate the effects of the intervention on mental health outcomes, including symptoms of depression, anxiety, and PTSD, as well as IPV experiences and other psychosocial outcomes, from baseline through 12 months of follow-up.
The findings from this study will provide evidence regarding the efficacy of a culturally tailored mHealth intervention to improve mental health and well-being among Chinese immigrant women experiencing IPV. If effective, the SHE intervention has the potential to increase access to culturally appropriate support and reduce disparities in mental health care for this underserved population.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Yang Li
- Telefonnummer: 512-471-9075
- E-mail: yang.li@nursing.utexas.edu
Studiesteder
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Texas
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Austin, Texas, Forenede Stater, 78712
- The University of Texas at Austin
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Kontakt:
- Yang Li
- Telefonnummer: 512-471-9075
- E-mail: yang.li@nursing.utexas.edu
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: The SHE intervention group
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.
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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.
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Aktiv komparator: The attention control group
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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Depression symptoms
Tidsramme: Baseline and 6-week, 3-month, 6-month, and 12-month follow-ups
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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.
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Baseline and 6-week, 3-month, 6-month, and 12-month follow-ups
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Anxiety symptoms
Tidsramme: Baseline and 6-week, 3-month, 6-month, and 12-month follow-ups
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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.
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Baseline and 6-week, 3-month, 6-month, and 12-month follow-ups
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Symptoms of post-traumatic stress disorder (PTSD)
Tidsramme: Baseline and 6-week, 3-month, 6-month, and 12-month follow-ups
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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.
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Baseline and 6-week, 3-month, 6-month, and 12-month follow-ups
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Intimate partner violence
Tidsramme: Baseline and 6-week, 3-month, 6-month, and 12-month follow-ups
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The instrument used will be the Revised Conflict Tactics Scales.
Item scores within each subscale were summed, with higher scores indicating more frequent experiences of the corresponding behaviors.
The scale consists of five subscales: negotiation (6 items; score range = 0-150), psychological aggression (8 items; score range = 0-200), physical assault (12 items; score range = 0-300), sexual coercion (7 items; score range = 0-175), and injury (6 items; score range = 0-150).
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Baseline and 6-week, 3-month, 6-month, and 12-month follow-ups
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00007939
- 1R01NR022445-01A1 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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