Intimate Partner ViolenceNCT05011552
Feasibility Study for Abused Chinese Immigrant Women
A study testing Self-Compassion, Health, and Empowerment (SHE) in people with Intimate Partner Violence and Depression, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence, Depression, Anxiety
- What is being tested?
- Self-Compassion, Health, and Empowerment (SHE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 3 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Women are excluded if they report substance use or suicidality or having been in mental health care for severe mental illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas At Austin
Austin, Texas, 78712
About this study
Official title: Self-Compassion, Health, and Empowerment: A Feasibility Intervention Study for Chinese Immigrant Women With Intimate Partner Violence in the U.S.
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.
- Conditions
- Intimate Partner Violence, Depression, Anxiety, PTSD
- Being tested
- Self-Compassion, Health, and Empowerment (SHE), The Control Condition
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Compassion, Health, and Empowerment (SHE)Behavioural
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 ConditionBehavioural
Women randomized to the control group will be provided with the same brochure and mental health care resources.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | Not described Receives: Behavioral: Self-Compassion, Health, and Empowerment (SHE) |
| The control group | Placebo comparator | Not described Receives: Behavioral: The Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intimate Partner Violence
The Revised Conflict Tactics Scales (CTS2)
Measured: It will be assessed at baseline before the start of the 8-week intervention.
Intimate Partner Violence
The Revised Conflict Tactics Scales (CTS2)
Measured: It will be assessed immediately after the 8-week intervention.
Intimate Partner Violence
The Revised Conflict Tactics Scales (CTS2)
Measured: It will be assessed 2 months after the 8-week intervention.
Depression
The Patient Health Questionnaire-9 (PHQ-9)
Measured: It will be assessed at baseline before the start of the 8-week intervention.
Depression
The Patient Health Questionnaire-9 (PHQ-9)
Measured: It will be assessed immediately after the 8-week intervention.
Depression
The Patient Health Questionnaire-9 (PHQ-9)
Measured: It will be assessed 2 months after the 8-week intervention.
Anxiety
The Generalized Anxiety Disorder-7 (GAD-7)
Measured: It will be assessed at baseline before the start of the 8-week intervention.
Anxiety
The Generalized Anxiety Disorder-7 (GAD-7)
Measured: It will be assessed immediately after the 8-week intervention.
Anxiety
The Generalized Anxiety Disorder-7 (GAD-7)
Measured: It will be assessed 2 months after the 8-week intervention.
Posttraumatic Stress Disorder (PTSD)
The PTSD Checklist for DSM-5 (PCL-5)
Measured: It will be assessed at baseline before the start of the 8-week intervention.
Posttraumatic Stress Disorder (PTSD)
The PTSD Checklist for DSM-5 (PCL-5)
Measured: It will be assessed immediately after the 8-week intervention.
Posttraumatic Stress Disorder (PTSD)
The PTSD Checklist for DSM-5 (PCL-5)
Measured: It will be assessed 2 months after the 8-week intervention.
Secondary outcomes (6)
Number of Safety Behaviors Taken by Participants
The Intimate Partner Violence Strategies Index
Measured: It will be assessed at baseline before the start of the 8-week intervention.
Number of Safety Behaviors Taken by Participants
The Intimate Partner Violence Strategies Index
Measured: It will be assessed immediately after the 8-week intervention.
Number of Safety Behaviors Taken by Participants
The Intimate Partner Violence Strategies Index
Measured: It will be assessed 2 months after the 8-week intervention.
Self-Compassion
The Self-Compassion Scale-Short Form (SCS-SF)
Measured: It will be assessed at baseline before the start of the 8-week intervention.
Self-Compassion
The Self-Compassion Scale-Short Form (SCS-SF)
Measured: It will be assessed immediately after the 8-week intervention.
Self-Compassion
The Self-Compassion Scale-Short Form (SCS-SF)
Measured: It will be assessed 2 months after the 8-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Mar 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Li, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011552
- Sponsor's protocol ID
- STUDY00001645
- Status last verified
- Apr 2023
- First submitted
- 10 Aug 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li Y, Rhee H, Bullock LFC, McCaw B, Bloom T. Self-Compassion, Health, and Empowerment: A Pilot Randomized Controlled Trial for Chinese Immigrant Women Experiencing Intimate Partner Violence. J Interpers Violence. 2024 Apr;39(7-8):1571-1595. doi: 10.1177/08862605231207624. Epub 2023 Oct 30.
PubMed 37902465
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Compassion, Health, and Empowerment: A Feasibility Intervention Study for Chinese Immigrant Women With Intimate Partner Violence in the U.S.
- ClinicalTrials.gov ID
- NCT05011552
- Acronym / sponsor ID
- STUDY00001645
- Conditions
- Intimate Partner Violence, Depression, Anxiety, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: Self-Compassion, Health, and Empowerment (SHE) |
| The control group | Placebo comparator | Behavioral: The Control Condition |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Women are excluded if they report substance use or suicidality or having been in mental health care for severe mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | The intervention group |
| The Control ConditionWomen randomized to the control group will be provided with the same brochure and mental health care resources. | Behavioural | The control group |
Primary outcome
Intimate Partner Violence
Time frame: It will be assessed at baseline before the start of the 8-week intervention.
The Revised Conflict Tactics Scales (CTS2)
Intimate Partner Violence
Time frame: It will be assessed immediately after the 8-week intervention.
The Revised Conflict Tactics Scales (CTS2)
Intimate Partner Violence
Time frame: It will be assessed 2 months after the 8-week intervention.
The Revised Conflict Tactics Scales (CTS2)
Depression
Time frame: It will be assessed at baseline before the start of the 8-week intervention.
The Patient Health Questionnaire-9 (PHQ-9)
Depression
Time frame: It will be assessed immediately after the 8-week intervention.
The Patient Health Questionnaire-9 (PHQ-9)
Depression
Time frame: It will be assessed 2 months after the 8-week intervention.
The Patient Health Questionnaire-9 (PHQ-9)
Anxiety
Time frame: It will be assessed at baseline before the start of the 8-week intervention.
The Generalized Anxiety Disorder-7 (GAD-7)
Anxiety
Time frame: It will be assessed immediately after the 8-week intervention.
The Generalized Anxiety Disorder-7 (GAD-7)
Anxiety
Time frame: It will be assessed 2 months after the 8-week intervention.
The Generalized Anxiety Disorder-7 (GAD-7)
Posttraumatic Stress Disorder (PTSD)
Time frame: It will be assessed at baseline before the start of the 8-week intervention.
The PTSD Checklist for DSM-5 (PCL-5)
Posttraumatic Stress Disorder (PTSD)
Time frame: It will be assessed immediately after the 8-week intervention.
The PTSD Checklist for DSM-5 (PCL-5)
Posttraumatic Stress Disorder (PTSD)
Time frame: It will be assessed 2 months after the 8-week intervention.
The PTSD Checklist for DSM-5 (PCL-5)
6 secondary outcomes
Number of Safety Behaviors Taken by Participants
Time frame: It will be assessed at baseline before the start of the 8-week intervention.
Number of Safety Behaviors Taken by Participants
Time frame: It will be assessed immediately after the 8-week intervention.
Number of Safety Behaviors Taken by Participants
Time frame: It will be assessed 2 months after the 8-week intervention.
Self-Compassion
Time frame: It will be assessed at baseline before the start of the 8-week intervention.
Self-Compassion
Time frame: It will be assessed immediately after the 8-week intervention.
Self-Compassion
Time frame: It will be assessed 2 months after the 8-week intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 37902465Li Y, Rhee H, Bullock LFC, McCaw B, Bloom T. Self-Compassion, Health, and Empowerment: A Pilot Randomized Controlled Trial for Chinese Immigrant Women Experiencing Intimate Partner Violence. J Interpers Violence. 2024 Apr;39(7-8):1571-1595. doi: 10.1177/08862605231207624. Epub 2023 Oct 30.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Compassion, Health, and Empowerment (SHE) in people with Intimate Partner Violence and Depression, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intimate Partner Violence (time frame: It will be assessed at baseline before the start of the 8-week intervention.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05011552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.