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Yoga for Black and Brown Women Who Have Experienced Abuse From an Intimate Partner

Study acronym: SOAR
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Recruitment opened
    • Secondary endpoints revised (5)
    • Study description shortened, about 107 words
    • Site details revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07546266
Lead Sponsor The University of Akron
Conditions
(from sponsor)
Intimate Partner Violence (IPV), Psychological Well Being, Psychological Trauma, Historical
Related terms Historical Trauma, Psychological Well-Being
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov