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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05011552
Other study ID # STUDY00001645
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date March 3, 2023

Study information

Verified date April 2023
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 3, 2023
Est. primary completion date March 3, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 18 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. Exclusion Criteria: - Women are excluded if they report substance use or suicidality or having been in mental health care for severe mental illness.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Self-Compassion, Health, and Empowerment (SHE)
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 Control Condition
Women randomized to the control group will be provided with the same brochure and mental health care resources.

Locations

Country Name City State
United States The University of Texas At Austin Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intimate Partner Violence The Revised Conflict Tactics Scales (CTS2) It will be assessed at baseline before the start of the 8-week intervention.
Primary Intimate Partner Violence The Revised Conflict Tactics Scales (CTS2) It will be assessed immediately after the 8-week intervention.
Primary Intimate Partner Violence The Revised Conflict Tactics Scales (CTS2) It will be assessed 2 months after the 8-week intervention.
Primary Depression The Patient Health Questionnaire-9 (PHQ-9) It will be assessed at baseline before the start of the 8-week intervention.
Primary Depression The Patient Health Questionnaire-9 (PHQ-9) It will be assessed immediately after the 8-week intervention.
Primary Depression The Patient Health Questionnaire-9 (PHQ-9) It will be assessed 2 months after the 8-week intervention.
Primary Anxiety The Generalized Anxiety Disorder-7 (GAD-7) It will be assessed at baseline before the start of the 8-week intervention.
Primary Anxiety The Generalized Anxiety Disorder-7 (GAD-7) It will be assessed immediately after the 8-week intervention.
Primary Anxiety The Generalized Anxiety Disorder-7 (GAD-7) It will be assessed 2 months after the 8-week intervention.
Primary 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.
Primary Posttraumatic Stress Disorder (PTSD) The PTSD Checklist for DSM-5 (PCL-5) It will be assessed immediately after the 8-week intervention.
Primary Posttraumatic Stress Disorder (PTSD) The PTSD Checklist for DSM-5 (PCL-5) It will be assessed 2 months after the 8-week intervention.
Secondary Number of Safety Behaviors Taken by Participants The Intimate Partner Violence Strategies Index It will be assessed at baseline before the start of the 8-week intervention.
Secondary Number of Safety Behaviors Taken by Participants The Intimate Partner Violence Strategies Index It will be assessed immediately after the 8-week intervention.
Secondary Number of Safety Behaviors Taken by Participants The Intimate Partner Violence Strategies Index It will be assessed 2 months after the 8-week intervention.
Secondary Self-Compassion The Self-Compassion Scale-Short Form (SCS-SF) It will be assessed at baseline before the start of the 8-week intervention.
Secondary Self-Compassion The Self-Compassion Scale-Short Form (SCS-SF) It will be assessed immediately after the 8-week intervention.
Secondary Self-Compassion The Self-Compassion Scale-Short Form (SCS-SF) It will be assessed 2 months after the 8-week intervention.
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