Depression and Quality of LifeESDNCT07712796
Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence
A study testing Empowerment self-defense training in people with Depression and Quality of Life and Sexual Violence, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to culturally adapt and evaluate an empowerment self-defense (ESD) program (i.e., IMpower) for AI/AN women who have experienced SV in their lifetime and currently experiencing moderate to severe levels of depression and/or PTSD symptoms (primary outcomes). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression and Quality of Life, Sexual Violence, PTSD
- What is being tested?
- Empowerment self-defense training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 14 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identify as Indigenous (including American Indian or Alaska Native), including individuals who identify as multiracial and Indigenous.
- Identify as a woman, trans woman, and/or Two Spirit..
- Be 18 years of age or older.
- Have experienced sexual violence or unwanted sexual experiences.
- Report moderate to high levels of Meet criteria for depression and/or PTSD.
- NOT report high risk for suicidality
Show all 10Show fewer
- NOT report active psychosis
- Live on or near the Pine Ridge Indian Reservation.
- Be able to read and speak English.
- Report an ability and willingness to participate in the program sessions and related research activities, including surveys and potential exit interviews.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wahwala Iyohlogya/Peaceful Means
Pine Ridge, South Dakota, 57770
Thalia Wilson, Project Research Coordinator, BS, 605-430-9575, peacefulmeans@umich.edu
About this study
Official title: Development and Evaluation of a Culturally Grounded Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence: Open Pilot Trial
The purpose of this study is to culturally adapt and evaluate an empowerment self-defense (ESD) program (i.e., IMpower) for AI/AN women who have experienced SV in their lifetime and currently experiencing moderate to severe levels of depression and/or PTSD symptoms (primary outcomes). Previous research with non-AI/AN women finds that ESD reduces depression and PTSD symptoms, but no research has examined ESD among AI/AN survivors despite calls from our tribal partners to implement ESD with AI/AN adult women survivors. The investigators have assembled an interdisciplinary expert team and Elders/Traditional Knowledge Keepers (TKKs) as well as Survivor Advisory Board (SAB) in the proposed work.
Read the detailed description
American Indian/Alaska Native (AI/AN) women experience disproportionately high rates of sexual violence (SV) and subsequent symptoms of depression and posttraumatic stress disorder (PTSD) as well as related issues such as suicidality, problem drinking, sexual revictimization, and intimate partner violence (IPV). Science knows little about how to address mental health problems related to SV in AI/AN women, particularly those living in rural/remote tribal communities where access to quality care is limited or non-existent. Current best practices for AI/AN populations suggest that existing empirically supported treatments for mental health concerns have limited applicability and stress the need to develop and test culturally adapted interventions. The current proposal supports a culturally grounded mental health initiative that centers AI/AN voices, leverages the power of connection to others, and moves away from individualistic interventions.
Aim 1 (Adaptation) includes using an Indigenized ADAPT-ITT Model to refine IMpower into an Indigenized ESD for survivors (IMpower-Survivors) via ongoing feedback from the Topical Experts/TKKs and the SAB (Aim 1a), theatre testing IMpower-Survivors (Aim 1b), and an open pilot trial of the IMpower-Survivors with 14 AI/AN women survivors to further refine and evaluate the feasibility of the program and research procedures (Aim 1c).
Aim 2 (Evaluation) will include a pilot RCT of 100 AI/AN women who have experienced SV and have elevated PTSD and/or depressive symptoms randomly assigned to the treatment or wait list control condition. The investigators will assess the acceptability and feasibility of the IMpower-Survivors (Aim 2a) via program observations, post-session surveys, and exit interviews with AI/AN women who have survived SV. The investigators will test the hypotheses that IMpower-Survivors will lead to changes in intervention targets (reduced fear of future SV, reduced self-blame, increased empowerment, increased social support, and increased cultural identity) compared to the wait-list control condition (Aim 2b). The investigators will also examine the hypotheses that there will be reductions in symptoms of depression and PTSD (primary outcomes; Aim 2c) and suicidality, problem drinking, exposure to IPV, and sexual revictimization (secondary outcomes; Aim 2d) among AI/AN women survivors in the treatment condition compared to control.
*NOTE: This registration is for the open pilot trial (Aim 1c).
- Conditions
- Depression and Quality of Life, Sexual Violence, PTSD, Suicidal Ideation, Problem Drinking
- Being tested
- Empowerment self-defense training
- Keywords
- Native American, Sexual violence, Depression
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Suicidal Ideation, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment self-defense trainingBehavioural
Participants will take part in the empowerment self-defense (ESD) program delivered in a small-group format. Sessions will be facilitated by trained facilitators and will focus on empowerment, personal safety skills, boundary setting, communication strategies, and trauma-informed discussions relevant to survivors of sexual violence.
Sessions will follow a structured curriculum designed to provide participants with practical skills for recognizing risk, setting boundaries, and responding to potentially harmful situations.
Facilitators delivering the program receive training in trauma-informed practice and are already certified to teach the ESD curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Open Pilot Trial | Experimental | Empowerment self-defense curriculum and practical skills training for Indigenous women survivors. Receives: Behavioral: Empowerment self-defense training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Participant responses to depressive symptoms in the past two weeks using items from the Patient Health Questionnaire (PHQ-9). The 9-item scale includes likert options ranging from 0 = Not at all to 3 = Nearly every day. Higher scores indicate more depressive symptoms.
Measured: Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
PTSD
Participant responses to items from the PTSD checklist for DSM-5 to measure post traumatic stress disorder behaviors in the past month. The 20-item scale includes likert response options ranging from 0 = Not at all to 4 = Extremely with higher scores indicating more trauma related stress.
Measured: Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion)
Secondary outcomes (6)
Suicidal Ideation
Participants will respond to items on the Suicidal Ideation Attributes Scale. This is a five measure with a slider scale from 0=never to 10=always. A score greater or equal to 21 is an elevated suicide risk. A score of 0 - 20: Indicates the presence of suicidal thoughts but generally reflects a lower behavioral risk. A score of 21 or higher: Indicates a higher risk of suicidal thoughts and behavior.
Measured: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Alcohol Misuse
Participants will respond to items on the Alcohol Use Disorders Identification Test. This measures the participants alcohol use. This is a 10 item multiple choice option scale. For items 1-8, 0=never, 1=monthly or less, 2=2-4 times a month, 3=2-3 times a week, 4=4 or more times a week/daily/almost daily. For item 2 (special response) 0=1 or 2 drinks, 1=3 or 4 drinks, 2=5 or 6 drinks, 3=7 to 9 drinks, 4=10 or more drinks. For items 9-10, choices are 0=No, 2=Yes, but not in the last month, 4=Yes, during the last month.
The AUDIT (a 10-question survey) is scored from 0 to 40 with higher scores indicating hazardous or harmful alcohol consumption and a higher probability of alcohol dependence.
Measured: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Drug Use
Participants will respond to items on the Drug Use Disorders Identification Test. This measures the participants use of drugs other than alcohol. This is a 11 items measure with multiple choice options. For items 1-2 the options are 0=Never, 1=Once a month or less often, 2=2-4 times month, 3=2-3 times a week, 4=4 times a week or more often. For item 3, the choices are 0=0, 1=1-2, 2=3-4, 3=5-6, 4=7 or more. For items 4-9, the choices are 0=never, 1=Less often than once a month, 2=Every month, 3=Every week, 4=Daily or almost every day. For items 10-11, the choices are 0=no, 1=Yes, but not over the past month, 2=Yes, over the past month.
A higher score on the DUDIT (Drug Use Disorders Identification Test) indicates a higher likelihood of harmful drug use, substance abuse, or drug dependence.
Measured: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Suicide
Participant responses to items from the Columbia Suicide Severity Rating Scale (C-SSRS) Self Report to measure suicide and life-threatening behavior in the past month. The 6-item scale includes two response options ranging from 0 = No to 1 = Yes with higher scores indicating severity of suicidal ideation. Low risk : score of 1-2; Moderate risk: score of 3 or certain history; High risk: score of 4-6 A higher score indicates increased levels of suicide risk and future suicidal behavior.
Measured: Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Intimate Partner Violence
Participants will respond to items on the Conflict Tactics Scale Revised including subscales: psychological aggression, physical assault, sexual coercion or injury. This scale measures the participant's relationship with their partner in the past month. The scale is an 78 item multiple choice scale with the ranges of 0=Once in the past month, 1=Once in the past month, 2=Twice in the past month, 3=3-5 times in the past month, 4=6-10 times in the past month, 5=11-20 times in the past month, and 6=More than 20 times int he past month.
A higher score indicates a higher frequency and severity of intimate partner violence. A higher score on the negotiation subscale indicates better outcomes to resolve relationship conflicts.
Measured: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Sexual Victimization
Participants will respond to selected items on the Sexual Experiences Survey Victimization Version-Acts Collapsed. This is a scale divided into 4 sections: Non-contact, Cybersex, Contact and Sexual Pressure. Non-contact is 3 items with a scale from 0-10+ times since participant's 14th birthday, Cybersex is 2 items with a scale from 0-10+ times since participant's 14th birthday, Contact is 9 items with 4 subitems each with a scale from 0-10+ times since participant's 14th birthday, and Sexual Pressure is 3 items with 4 subitems each with a scale from 0-10+ times since participant's 14th birthday.
A higher score indicates a higher lifetime prevalence, frequency, or severity of unwanted sexual experiences or sexual exploitation.
Measured: Collected during the pre-test (enrollment) for lifetime and past 30 days AND post-test for past 30 days (within 1 week of intervention conclusion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion14 Jun 2028 (estimated)
- Study completion14 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression and Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Katie M Edwards, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712796
- Sponsor's protocol ID
- HUM00291298
- Other IDs
- R34MH139782
- Acronym
- ESD
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Culturally Grounded Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence: Open Pilot Trial
- ClinicalTrials.gov ID
- NCT07712796
- Acronym / sponsor ID
- ESD / HUM00291298
- Conditions
- Depression and Quality of Life, Sexual Violence, PTSD, Suicidal Ideation, Problem Drinking
- Keywords
- Native American, Sexual violence, Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 14 Jun 2028 (estimated)
- Study completion
- 14 Jun 2028 (estimated)
- First posted
- 20 Jul 2026 (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.
The purpose of this study is to culturally adapt and evaluate an empowerment self-defense (ESD) program (i.e., IMpower) for AI/AN women who have experienced SV in their lifetime and currently experiencing moderate to severe levels of depression and/or PTSD symptoms (primary outcomes). Previous research with non-AI/AN women finds that ESD reduces depression and PTSD symptoms, but no research has examined ESD among AI/AN survivors despite calls from our tribal partners to implement ESD with AI/AN adult women survivors. The investigators have assembled an interdisciplinary expert team and Elders/Traditional Knowledge Keepers (TKKs) as well as Survivor Advisory Board (SAB) in the proposed work.
Detailed description
American Indian/Alaska Native (AI/AN) women experience disproportionately high rates of sexual violence (SV) and subsequent symptoms of depression and posttraumatic stress disorder (PTSD) as well as related issues such as suicidality, problem drinking, sexual revictimization, and intimate partner violence (IPV). Science knows little about how to address mental health problems related to SV in AI/AN women, particularly those living in rural/remote tribal communities where access to quality care is limited or non-existent. Current best practices for AI/AN populations suggest that existing empirically supported treatments for mental health concerns have limited applicability and stress the need to develop and test culturally adapted interventions. The current proposal supports a culturally grounded mental health initiative that centers AI/AN voices, leverages the power of connection to others, and moves away from individualistic interventions.
Aim 1 (Adaptation) includes using an Indigenized ADAPT-ITT Model to refine IMpower into an Indigenized ESD for survivors (IMpower-Survivors) via ongoing feedback from the Topical Experts/TKKs and the SAB (Aim 1a), theatre testing IMpower-Survivors (Aim 1b), and an open pilot trial of the IMpower-Survivors with 14 AI/AN women survivors to further refine and evaluate the feasibility of the program and research procedures (Aim 1c).
Aim 2 (Evaluation) will include a pilot RCT of 100 AI/AN women who have experienced SV and have elevated PTSD and/or depressive symptoms randomly assigned to the treatment or wait list control condition. The investigators will assess the acceptability and feasibility of the IMpower-Survivors (Aim 2a) via program observations, post-session surveys, and exit interviews with AI/AN women who have survived SV. The investigators will test the hypotheses that IMpower-Survivors will lead to changes in intervention targets (reduced fear of future SV, reduced self-blame, increased empowerment, increased social support, and increased cultural identity) compared to the wait-list control condition (Aim 2b). The investigators will also examine the hypotheses that there will be reductions in symptoms of depression and PTSD (primary outcomes; Aim 2c) and suicidality, problem drinking, exposure to IPV, and sexual revictimization (secondary outcomes; Aim 2d) among AI/AN women survivors in the treatment condition compared to control.
*NOTE: This registration is for the open pilot trial (Aim 1c).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention
| Arm | Type | Receives |
|---|---|---|
| Open Pilot Trial | Experimental | Behavioral: Empowerment self-defense trainingEmpowerment self-defense curriculum and practical skills training for Indigenous women survivors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Identify as Indigenous (including American Indian or Alaska Native), including individuals who identify as multiracial and Indigenous.
- Identify as a woman, trans woman, and/or Two Spirit..
- Be 18 years of age or older.
- Have experienced sexual violence or unwanted sexual experiences.
- Report moderate to high levels of Meet criteria for depression and/or PTSD.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Empowerment self-defense trainingParticipants will take part in the empowerment self-defense (ESD) program delivered in a small-group format. Sessions will be facilitated by trained facilitators and will focus on empowerment, personal safety skills, boundary setting, communication strategies, and trauma-informed discussions relevant to survivors of sexual violence. Sessions will follow a structured curriculum designed to provide participants with practical skills for recognizing risk, setting boundaries, and responding to potentially harmful situations. Facilitators delivering the program receive training in trauma-informed practice and are already certified to teach the ESD curriculum. | Behavioural | Open Pilot Trial |
Primary outcome
Depression
Time frame: Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Participant responses to depressive symptoms in the past two weeks using items from the Patient Health Questionnaire (PHQ-9). The 9-item scale includes likert options ranging from 0 = Not at all to 3 = Nearly every day. Higher scores indicate more depressive symptoms.
PTSD
Time frame: Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion)
Participant responses to items from the PTSD checklist for DSM-5 to measure post traumatic stress disorder behaviors in the past month. The 20-item scale includes likert response options ranging from 0 = Not at all to 4 = Extremely with higher scores indicating more trauma related stress.
6 secondary outcomes
Suicidal Ideation
Time frame: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Alcohol Misuse
Time frame: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Drug Use
Time frame: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Suicide
Time frame: Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Intimate Partner Violence
Time frame: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Sexual Victimization
Time frame: Collected during the pre-test (enrollment) for lifetime and past 30 days AND post-test for past 30 days (within 1 week of intervention conclusion).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Survivor Empowerment Self-DefenseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment self-defense training in people with Depression and Quality of Life and Sexual Violence, run by University of Michigan 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 10 inclusion and 0 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: opening soon, as of the sponsor's last update on 21 Aug 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Edwards (Principal Investigator),, PHD (734-647-8812, edkatie@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.