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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yang Li
- Numéro de téléphone: 512-471-9075
- E-mail: yang.li@nursing.utexas.edu
Lieux d'étude
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Texas
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Austin, Texas, États-Unis, 78712
- The University of Texas at Austin
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Contact:
- Yang Li
- Numéro de téléphone: 512-471-9075
- E-mail: yang.li@nursing.utexas.edu
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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|
Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Depression symptoms
Délai: 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
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Intimate partner violence
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00007939
- 1R01NR022445-01A1 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
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