Език: EN EN
← Назад към резултатите
Предстои набиране Фаза 1 NCT07546266

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

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Intimate Partner Violence (IPV) Psychological Well Being Psychological Trauma, Historical

Спонсор: The University of Akron

Налично на: БГ
Обобщение
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.
Описание
We 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 (see below). 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 goal is to lay the groundwork for a successful, fully powered RCT. In this pilot RCT, we will assess the feasibility, acceptability, and safety of the intervention and research design and examine within-group changes of our primary outcome of psychological well-being and secondary outcomes of empowerment, resilience, health-related quality of life, collective self-esteem, and culturally specific coping. All participants will complete assessments at baseline, 16 weeks, and 27 weeks. Our inclusion criteria are: (1) 18 years of age or older, (2) Self-identify as Black or Brown woman/Woman of Color, (3) Lifetime experience of IPV, and (4) Willingness to complete yoga program and research 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 y
Кой може да участва
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
Интервенции
Culturally-Tailored, Trauma-Informed Yoga (CT-TIY)
BEHAVIORAL
Enhanced Care as Usual (ECU)
OTHER
Места на провеждане 1
САЩ (1)
the University of Akron
Akron , Ohio
Dawn M Johnson, Ph.D.
Технически детайли
Статус
Предстои набиране
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Само жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
15.05.2026
Крайна дата
31.12.2027
Регистрационен номер
NCT07546266
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.