- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07546266
Yoga for Black and Brown Women Who Have Experienced Abuse From an Intimate Partner (SOAR)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Dawn Johnson, Ph.D.
- Phone Number: 330-972-7111
- Email: johnsod@uakron.edu
Study Locations
-
-
Ohio
-
Akron, Ohio, United States, 44313
- Recruiting
- the University of Akron
-
Contact:
- Dawn M Johnson, Ph.D.
- Phone Number: 330-972-2505
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Culturally Tailored, Trauma-Informed Yoga (CT-TIY)
15 weekly sessions of the SOAR yoga program
|
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.
Other Names:
|
|
Other: Enhanced Care as Usual (ECU)
Referral to domestic violence provider and the Futures without Violence General Health Safety Card
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline, 16 weeks, 27 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Personal Progress Scale Revised
Time Frame: Baseline, 16 weeks, 27 weeks
|
28 item scale measuring empowerment with scores ranging from 28 to 196; higher scores = higher empowerment
|
Baseline, 16 weeks, 27 weeks
|
|
Connor-Davidson Resilience Scale 10
Time Frame: Baseline, 16 weeks, 27 weeks
|
10 item measure of resilience with scores ranging from 0 to 40; higher scores = higher empowerment
|
Baseline, 16 weeks, 27 weeks
|
|
Short Form 8 Health Survey
Time Frame: Baseline, 16 weeks, 27 weeks
|
8 item measure of health-related quality of life with scores ranging from 0 to 100; higher scores = greater health-related quality of life
|
Baseline, 16 weeks, 27 weeks
|
|
Collective Self-Esteem Scale
Time Frame: Baseline, 16 weeks, 27 weeks
|
a 16-item measure of collective self-esteem with scores ranging from 16 to 112; higher scores = higher collective self-esteem
|
Baseline, 16 weeks, 27 weeks
|
|
Africultural Coping Systems Inventory
Time Frame: Baseline, 16 weeks, 27 weeks
|
30-item measure of cultural specific coping strategies , with scores ranging from 0-90; higher scores = more use of cultural specific coping strategies
|
Baseline, 16 weeks, 27 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2025-95
- 15JOVW-24-GG01529 (Other Grant/Funding Number: Office for Violence Against Women)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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