the University of Akron
Akron, Ohio, 44313, United States
Location status: Recruiting
NCT Number: NCT07546266
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 1
Akron, Ohio, 44313, United States
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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: SOAR
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
Time frame: Baseline, 16 weeks, 27 weeks
42 item measure of psychological wellbeing with scores ranging from 42-294; higher scores = higher wellbeing
Time frame: Baseline, 16 weeks, 27 weeks
28 item scale measuring empowerment with scores ranging from 28 to 196; higher scores = higher empowerment
Time frame: Baseline, 16 weeks, 27 weeks
10 item measure of resilience with scores ranging from 0 to 40; higher scores = higher empowerment
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
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
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
Contact information is provided by the study sponsor or research team.
The University of Akron
Other
A Culturally Tailored, Trauma-Informed Yoga Program for Women of Color Who Have Experienced Intimate Partner Violence
Acronym: SOAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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