NCT07546266

Brief Summary

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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
20mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

April 15, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

women of colorminority healthyogatrauma informedsister circlesdomestic violenceintimate partner violence

Outcome Measures

Primary Outcomes (1)

  • Ryff Psychological Wellbeing Scale

    42 item measure of psychological wellbeing with scores ranging from 42-294; higher scores = higher wellbeing

    Baseline, 16 weeks, 27 weeks

Secondary Outcomes (5)

  • Personal Progress Scale Revised

    Baseline, 16 weeks, 27 weeks

  • Connor-Davidson Resilience Scale 10

    Baseline, 16 weeks, 27 weeks

  • Short Form 8 Health Survey

    Baseline, 16 weeks, 27 weeks

  • Collective Self-Esteem Scale

    Baseline, 16 weeks, 27 weeks

  • Africultural Coping Systems Inventory

    Baseline, 16 weeks, 27 weeks

Study Arms (2)

Culturally Tailored, Trauma-Informed Yoga (CT-TIY)

EXPERIMENTAL

15 weekly sessions of the SOAR yoga program

Behavioral: Culturally-Tailored, Trauma-Informed Yoga (CT-TIY)

Enhanced Care as Usual (ECU)

OTHER

Referral to domestic violence provider and the Futures without Violence General Health Safety Card

Other: Enhanced Care as Usual (ECU)

Interventions

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.

Also known as: SOAR
Culturally Tailored, Trauma-Informed Yoga (CT-TIY)

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

Enhanced Care as Usual (ECU)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMust self-identify as women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the University of Akron

Akron, Ohio, 44313, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-BeingHistorical Trauma

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorPsychological TraumaStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Dawn Johnson, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to either a culturally tailored, trauma-informed yoga program or enhanced care as usual
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 22, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in this study (including text, tables, figures, and appendices) will be made available for use by other researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be made available upon completion of the study and publication of the primary findings. It is anticipated that archiving will occur within one year of the study's end date.
Access Criteria
De-identified individual participant data and supporting documents will be archived with the National Archive of Criminal Justice Data (NACJD). Interested researchers may access the data through the NACJD's established request and download procedures.

Locations