| NCT ID | NCT07195019 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Butler Hospital |
| Condition | Distress, Psychological |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-08-27 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-08-27 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase 2 is a randomized controlled trial of integrative yoga and mindful self-compassion program vs. women's wellbeing education for women with a history of interpersonal violence exposure and heightened distress.
Eligibility Criteria
Inclusion Criteria: 1. Female 2. Ages 18-65 3. Report having experienced interpersonal violence (defined to include all forms throughout the lifespan, confirmed with the Trauma History Questionnaire (THQ\]) 4. Report being distressed, defined by a score of \>5 on the Kessler-6 screener 5. Speak and understand English well enough to understand questionnaires when they are read aloud 6. Have access to a telephone through owning one, a relative/friend, or an agency 7. Have access to a device that will support use of the video platform we are using to conduct assessments and for home practice yoga video sessions Exclusion Criteria: 1. Inability to be physically active, determined by a score \>1 on the Physical Activity Readiness Questionnaire (PAR-Q) and physician non-consent of participation 2. Planned surgery in next 6 months, as this would interfere with study participation 3. Pregnancy, as yoga should be modified for pregnancy Women who meet criteria for the following: 4. Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) 5. Lifetime history of psychotic disorders (DIAMOND) 6. Current probable severe substance use disorder (DIAMOND) 7. Current diagnosis of anorexia nervosa or history in past year (DIAMOND) 8. Moderate or high risk for suicide on the adapted Columbia Suicide Severity Rating Scale screen version-recent (C-SSRS) and/or endorsement of suicidal plan/intent in the past 3 months 9. Non-stable course of psychiatric treatments (medication, psychotherapy) for the last 8 weeks 10. Plan to move from the area in the next 6 months, as this may preclude study participation given enrollment timeframes 11. Self-report of experiencing intimate partner violence currently or within past six months (assessed by the Revised Conflict Tactics Scale 2 \[R-CTS2\]), as this would require a different type of intervention 12. Current weekly yoga practice or current participation in mindfulness-based programming, as these are the study interventions
Frequently Asked Questions
Who can join the NCT07195019 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Distress, Psychological. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07195019 currently recruiting?
Yes, NCT07195019 is actively recruiting participants. Visit ClinicalTrials.gov or contact Butler Hospital to inquire about joining.
Where is the NCT07195019 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT07195019 clinical trial?
NCT07195019 is sponsored by Butler Hospital. The trial plans to enroll 48 participants.