About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Culturally-Tailored, Trauma-Informed Yoga (CT-TIY)
BehavioralParticipants 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 interventionParticipants 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
Treatment groups
Trial outcomes
Primary outcomes
Ryff Psychological Wellbeing Scale
42 item measure of psychological wellbeing with scores ranging from 42-294; higher scores = higher wellbeing
Secondary outcomes
Personal Progress Scale Revised
28 item scale measuring empowerment with scores ranging from 28 to 196; higher scores = higher empowerment
Connor-Davidson Resilience Scale 10
10 item measure of resilience with scores ranging from 0 to 40; higher scores = higher empowerment
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
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
Sponsors and contacts
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