Women's Wellbeing Study
Recruiting now · Not applicable
Conditions studied: Distress, Psychological
In brief
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.
Key facts
- Study ID
- NCT07195019
- Run by
- Butler Hospital
- People needed
- 48
- Starts
- 2025-08-27
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2025-09-26
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female
- Ages 18-65
- Report having experienced interpersonal violence (defined to include all forms throughout the lifespan, confirmed with the Trauma History Questionnaire (THQ])
- Report being distressed, defined by a score of >5 on the Kessler-6 screener
- Speak and understand English well enough to understand questionnaires when they are read aloud
- Have access to a telephone through owning one, a relative/friend, or an agency
- 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
You may not qualify if…
- Inability to be physically active, determined by a score >1 on the Physical Activity Readiness Questionnaire (PAR-Q) and physician non-consent of participation
- Planned surgery in next 6 months, as this would interfere with study participation
- Pregnancy, as yoga should be modified for pregnancy
- Women who meet criteria for the following:
- Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
- Lifetime history of psychotic disorders (DIAMOND)
- Current probable severe substance use disorder (DIAMOND)
- Current diagnosis of anorexia nervosa or history in past year (DIAMOND)
- 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
- Non-stable course of psychiatric treatments (medication, psychotherapy) for the last 8 weeks
- Plan to move from the area in the next 6 months, as this may preclude study participation given enrollment timeframes
- 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
- Current weekly yoga practice or current participation in mindfulness-based programming, as these are the study interventions
Where it is running
- Butler Hospital — Providence, Rhode Island, United States (enrolling)
Full record on ClinicalTrials.gov
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