ClinicalTrials.Veeva

Menu

Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence (ESD)

University of Michigan logo

University of Michigan

Status

Not yet enrolling

Conditions

Suicidal Ideation
Depression and Quality of Life
PTSD
Sexual Violence
Problem Drinking

Treatments

Behavioral: Empowerment self-defense training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07712796
HUM00291298
R34MH139782 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment

14 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • 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
  • 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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Open Pilot Trial
Experimental group
Description:
Empowerment self-defense curriculum and practical skills training for Indigenous women survivors.
Treatment:
Behavioral: Empowerment self-defense training

Trial contacts and locations

1

Loading...

Central trial contact

Katie Edwards (Principal Investigator),, PHD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems