Status:
RECRUITING
Women's Wellbeing Study
Lead Sponsor:
Butler Hospital
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Distress, Psychological
Eligibility:
FEMALE
18-65 years
Phase:
NA
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 heighte...
Detailed Description
In Phase 2, the investigators will conduct a pilot randomized controlled trial (RCT) of 12 weeks of integrative yoga and mindful self-compassion training (I-YMSC) vs. 12 weeks of women's wellbeing edu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07195019
Start Date
August 27 2025
End Date
May 31 2027
Last Update
September 26 2025
Active Locations (1)
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1
Butler Hospital
Providence, Rhode Island, United States, 02906