Intimate Partner Violence (IPV)Phase 1SOARNCT07546266
Yoga for Black and Brown Women Who Have Experienced Abuse From an Intimate Partner
A Phase 1 study testing Culturally-Tailored, Trauma-Informed Yoga (CT-TIY) and Enhanced Care as Usual (ECU) in people with Intimate Partner Violence (IPV) and Psychological Well Being, run by The University of Akron at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine if a culturally tailored and trauma-informed yoga (CT-TIY) program improves the overall well-being of Black and Brown women who have experienced IPV. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intimate Partner Violence (IPV), Psychological Well Being, Psychological Trauma, Historical
- What is being tested?
- Culturally-Tailored, Trauma-Informed Yoga (CT-TIY) and Enhanced Care as Usual (ECU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to 31 Dec 2027
- Phase
- Phase 1
- 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
- Self-identify as a Woman of Color (WOC).
- Lifetime experience of intimate partner violence (IPV)
- Age 18 years or older.
- Willingness to complete study procedures
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, 1 recruiting
- Recruiting
the University of Akron
Akron, Ohio, 44313
Dawn M Johnson, Ph.D., 330-972-2505
About this study
Official title: A Culturally Tailored, Trauma-Informed Yoga Program for Women of Color Who Have Experienced Intimate Partner Violence
The goal of this clinical trial is to determine if a culturally tailored and trauma-informed yoga (CT-TIY) program improves the overall well-being of Black and Brown women who have experienced IPV. The main questions it aims to answer are:
- What is the feasibility, acceptability, and safety of delivering the CT-TIY program?
- Do participants randomized to the CT-TIY program experience increases in our primary outcome of psychological well-being relative to women randomized to an enhanced care-as-usual control condition?
- Do participants randomized to the CT-TIY program experience improvements in our secondary outcomes of empowerment, resilience, health-related quality of life, collective self-esteem, and culturally specific coping relative to participants randomized to an enhanced care-as-usual control condition? Researchers will compare CT-TIY to enhanced care-as-usual to see if CT-TIY to determine the feasibility, acceptability, safety, as well as initial efficacy of the yoga program.
Read more
Participants randomized to the CT-TIY program will:
- Have 15 weeks to complete a target of 10 CT-TIY yoga classes
- Provide feedback on the CT-TIY program after each class they attend
- Complete assessments at Baseline, after completing the CT-TIY program (week 16), as well as 3-months (week 27) after completing the CT-TIY program
- Complete an exit interview where they provide feedback on their experiences in the yoga program
Participants randomized to the enhanced care-as-usual control condition will:
- Receive a referral to a domestic violence provider and the Futures without Violence General Health Safety Card, designed to help women recognize how their relationship impacts their health and the lives of their children, and provides information on safety planning and hotlines for support.
- Complete assessments at Baseline, week 16, and week 27 of the study.
Read the detailed description
Researchers will use a two-group, randomized controlled single-blind design with 40 women of color who have experienced intimate partner violence (WOC-IPV) who meet study criteria. After eligible participants have consented to participate and completed the baseline assessment, they will be randomized to CT-TIY or enhanced care as usual (ECU). The RA who completes assessments will be blind to intervention condition. Following the guidelines of Leon and colleagues, the primary purpose of this pilot study is to evaluate the feasibility and acceptability of the CT-TIY program, as well as the proposed recruitment, randomization, and retention procedures.
The Yoga Program (SOAR "Sisterhood Overcoming Adversity through Resilience"):
Before starting the yoga program, participants will attend a brief 20-min orientation session where they will meet 1-1 with a member of the research staff. This meeting will provide an overview of the program, provide yoga supplies (i.e., each participant will be provided their own mat, journal, and water bottle), and offer an opportunity for participants to ask questions privately (as opposed to within the yoga session). This session will also provide an opportunity to discuss safety concerns and how to address those concerns if any exist (e.g., safety practicing yoga at home, safely getting to yoga classes), as well as an opportunity for participants to decide that participating in the program may not be a safe option for them, given their current situation. This meeting will also emphasize that the yoga classes will provide invitations, where participants can take what they want and need from the class. Participants will be asked about physical limitations and health conditions and encouraged to speak to a medical professional to determine if the program is a good fit for them. Additionally, participants will be reminded that modifications will be provided for all activities and encouraged to listen to their bodies and do what feels comfortable in their bodies.
Each yoga class will be 75 minutes in length, although unlike yoga classes offered in the community, the entire 75 minutes will not be active movement. The focus of this yoga program is not exercise, but mindful reflection and movement. The general structure of yoga classes will be the same: (1) Time to settle in and be present in the body (this will include affirmations, journal prompts, essential oils), (2) Opening Ritual (e.g., chime, opening song, collective breath), (3) Mind-Theme (some education related to the theme), (4) Breathwork, (5) Mindful Movement/Asana, (6) Closing Rituals (e.g., Namaste, Ase, or Amen). Participants will be provided with consent cards at the beginning of each session- one side indicates that the participant is ok being touched and open to manual assists in session, and the other side indicates that the participant is not open to manual assists during the session). Manual assists will only be offered to those who indicate with their consent card that they are open to such assists (e.g., adjusting participants' poses so that they get the most out of the pose).
- Conditions
- Intimate Partner Violence (IPV), Psychological Well Being, Psychological Trauma, Historical
- Being tested
- Culturally-Tailored, Trauma-Informed Yoga (CT-TIY), Enhanced Care as Usual (ECU)
- Keywords
- women of color, minority health, yoga, trauma informed, sister circles, domestic violence, intimate partner violence
- Medical subject headings
- Psychological Well-Being, Historical Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally-Tailored, Trauma-Informed Yoga (CT-TIY)Behavioural
Also called SOAR
Participants will be offered 15 weekly yoga classes and encouraged to attend at least 10 classes. Each class will be 75 minutes long. Yoga classes will include time to settle in, opening and closing rituals, breathwork and mindful movement. Childcare and transportation assistance (e.g., bus passes, gas cards) will be provided.
Enhanced Care as Usual (ECU)Other
Participants will be offered a referral to a local domestic violence provider, as well as the Futures without Violence General health Safety Card which is designed to help women recognize how their relationship impacts their health and the lives of their children, and provides information on safety planning and hotlines for support
| Study group | Role | What they receive |
|---|---|---|
| Culturally Tailored, Trauma-Informed Yoga (CT-TIY) | Experimental | 15 weekly sessions of the SOAR yoga program Receives: Behavioral: Culturally-Tailored, Trauma-Informed Yoga (CT-TIY) |
| Enhanced Care as Usual (ECU) | Other | Referral to domestic violence provider and the Futures without Violence General Health Safety Card Receives: Other: Enhanced Care as Usual (ECU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ryff Psychological Wellbeing Scale
42 item measure of psychological wellbeing with scores ranging from 42-294; higher scores = higher wellbeing
Measured: Baseline, 16 weeks, 27 weeks
Secondary outcomes (5)
Personal Progress Scale Revised
28 item scale measuring empowerment with scores ranging from 28 to 196; higher scores = higher empowerment
Measured: Baseline, 16 weeks, 27 weeks
Connor-Davidson Resilience Scale 10
10 item measure of resilience with scores ranging from 0 to 40; higher scores = higher empowerment
Measured: Baseline, 16 weeks, 27 weeks
Short Form 8 Health Survey
8 item measure of health-related quality of life with scores ranging from 0 to 100; higher scores = greater health-related quality of life
Measured: Baseline, 16 weeks, 27 weeks
Collective Self-Esteem Scale
a 16-item measure of collective self-esteem with scores ranging from 16 to 112; higher scores = higher collective self-esteem
Measured: Baseline, 16 weeks, 27 weeks
Africultural Coping Systems Inventory
30-item measure of cultural specific coping strategies , with scores ranging from 0-90; higher scores = more use of cultural specific coping strategies
Measured: Baseline, 16 weeks, 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner Violence (IPV)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either a culturally tailored, trauma-informed yoga program or enhanced care as usual
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Akron
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546266
- Sponsor's protocol ID
- IRB-2025-95
- Other IDs
- 15JOVW-24-GG01529
- Acronym
- SOAR
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study (including text, tables, figures, and appendices) will be made available for use by other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally Tailored, Trauma-Informed Yoga Program for Women of Color Who Have Experienced Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT07546266
- Acronym / sponsor ID
- SOAR / IRB-2025-95
- Conditions
- Intimate Partner Violence (IPV), Psychological Well Being, Psychological Trauma, Historical
- Keywords
- women of color, minority health, yoga, trauma informed, sister circles, domestic violence, intimate partner violence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of AkronUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Apr 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 goal of this clinical trial is to determine if a culturally tailored and trauma-informed yoga (CT-TIY) program improves the overall well-being of Black and Brown women who have experienced IPV. The main questions it aims to answer are:
- What is the feasibility, acceptability, and safety of delivering the CT-TIY program?
- Do participants randomized to the CT-TIY program experience increases in our primary outcome of psychological well-being relative to women randomized to an enhanced care-as-usual control condition?
- Do participants randomized to the CT-TIY program experience improvements in our secondary outcomes of empowerment, resilience, health-related quality of life, collective self-esteem, and culturally specific coping relative to participants randomized to an enhanced care-as-usual control condition? Researchers will compare CT-TIY to enhanced care-as-usual to see if CT-TIY to determine the feasibility, acceptability, safety, as well as initial efficacy of the yoga program.
Participants randomized to the CT-TIY program will:
- Have 15 weeks to complete a target of 10 CT-TIY yoga classes
- Provide feedback on the CT-TIY program after each class they attend
- Complete assessments at Baseline, after completing the CT-TIY program (week 16), as well as 3-months (week 27) after completing the CT-TIY program
- Complete an exit interview where they provide feedback on their experiences in the yoga program
Participants randomized to the enhanced care-as-usual control condition will:
- Receive a referral to a domestic violence provider and the Futures without Violence General Health Safety Card, designed to help women recognize how their relationship impacts their health and the lives of their children, and provides information on safety planning and hotlines for support.
- Complete assessments at Baseline, week 16, and week 27 of the study.
Detailed description
Researchers will use a two-group, randomized controlled single-blind design with 40 women of color who have experienced intimate partner violence (WOC-IPV) who meet study criteria. After eligible participants have consented to participate and completed the baseline assessment, they will be randomized to CT-TIY or enhanced care as usual (ECU). The RA who completes assessments will be blind to intervention condition. Following the guidelines of Leon and colleagues, the primary purpose of this pilot study is to evaluate the feasibility and acceptability of the CT-TIY program, as well as the proposed recruitment, randomization, and retention procedures.
The Yoga Program (SOAR "Sisterhood Overcoming Adversity through Resilience"):
Before starting the yoga program, participants will attend a brief 20-min orientation session where they will meet 1-1 with a member of the research staff. This meeting will provide an overview of the program, provide yoga supplies (i.e., each participant will be provided their own mat, journal, and water bottle), and offer an opportunity for participants to ask questions privately (as opposed to within the yoga session). This session will also provide an opportunity to discuss safety concerns and how to address those concerns if any exist (e.g., safety practicing yoga at home, safely getting to yoga classes), as well as an opportunity for participants to decide that participating in the program may not be a safe option for them, given their current situation. This meeting will also emphasize that the yoga classes will provide invitations, where participants can take what they want and need from the class. Participants will be asked about physical limitations and health conditions and encouraged to speak to a medical professional to determine if the program is a good fit for them. Additionally, participants will be reminded that modifications will be provided for all activities and encouraged to listen to their bodies and do what feels comfortable in their bodies.
Each yoga class will be 75 minutes in length, although unlike yoga classes offered in the community, the entire 75 minutes will not be active movement. The focus of this yoga program is not exercise, but mindful reflection and movement. The general structure of yoga classes will be the same: (1) Time to settle in and be present in the body (this will include affirmations, journal prompts, essential oils), (2) Opening Ritual (e.g., chime, opening song, collective breath), (3) Mind-Theme (some education related to the theme), (4) Breathwork, (5) Mindful Movement/Asana, (6) Closing Rituals (e.g., Namaste, Ase, or Amen). Participants will be provided with consent cards at the beginning of each session- one side indicates that the participant is ok being touched and open to manual assists in session, and the other side indicates that the participant is not open to manual assists during the session). Manual assists will only be offered to those who indicate with their consent card that they are open to such assists (e.g., adjusting participants' poses so that they get the most out of the pose).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either a culturally tailored, trauma-informed yoga program or enhanced care as usual
| Arm | Type | Receives |
|---|---|---|
| Culturally Tailored, Trauma-Informed Yoga (CT-TIY) | Experimental | Behavioral: Culturally-Tailored, Trauma-Informed Yoga (CT-TIY)15 weekly sessions of the SOAR yoga program |
| Enhanced Care as Usual (ECU) | Other | Other: Enhanced Care as Usual (ECU)Referral to domestic violence provider and the Futures without Violence General Health Safety Card |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-identify as a Woman of Color (WOC).
- Lifetime experience of intimate partner violence (IPV)
- Age 18 years or older.
- Willingness to complete study procedures
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 |
|---|---|---|
| Culturally-Tailored, Trauma-Informed Yoga (CT-TIY)Also: SOARParticipants will be offered 15 weekly yoga classes and encouraged to attend at least 10 classes. Each class will be 75 minutes long. Yoga classes will include time to settle in, opening and closing rituals, breathwork and mindful movement. Childcare and transportation assistance (e.g., bus passes, gas cards) will be provided. | Behavioural | Culturally Tailored, Trauma-Informed Yoga (CT-TIY) |
| Enhanced Care as Usual (ECU)Participants will be offered a referral to a local domestic violence provider, as well as the Futures without Violence General health Safety Card which is designed to help women recognize how their relationship impacts their health and the lives of their children, and provides information on safety planning and hotlines for support | Other | Enhanced Care as Usual (ECU) |
Primary outcome
Ryff Psychological Wellbeing Scale
Time frame: Baseline, 16 weeks, 27 weeks
42 item measure of psychological wellbeing with scores ranging from 42-294; higher scores = higher wellbeing
5 secondary outcomes
Personal Progress Scale Revised
Time frame: Baseline, 16 weeks, 27 weeks
Connor-Davidson Resilience Scale 10
Time frame: Baseline, 16 weeks, 27 weeks
Short Form 8 Health Survey
Time frame: Baseline, 16 weeks, 27 weeks
Collective Self-Esteem Scale
Time frame: Baseline, 16 weeks, 27 weeks
Africultural Coping Systems Inventory
Time frame: Baseline, 16 weeks, 27 weeks
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 28 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study (including text, tables, figures, and appendices) will be made available for use by other researchers.
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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 Phase 1 study testing Culturally-Tailored, Trauma-Informed Yoga (CT-TIY) and Enhanced Care as Usual (ECU) in people with Intimate Partner Violence (IPV) and Psychological Well Being, run by The University of Akron 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 4 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: looking for participants now, as of the sponsor's last update on 28 Apr 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dawn Johnson, Ph.D. (330-972-7111, johnsod@uakron.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ryff Psychological Wellbeing Scale (time frame: Baseline, 16 weeks, 27 weeks). 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 28 Apr 2026.