Feasibility Study for Abused Chinese Immigrant Women

Depression Clinical Trial

Official title:

Self-Compassion, Health, and Empowerment: A Feasibility Intervention Study for Chinese Immigrant Women With Intimate Partner Violence in the U.S.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05011552
• Other study ID #: STUDY00001645
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Intimate Partner Violence
• PTSD

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.