RecruitingNot ApplicableNCT07195019

Women's Wellbeing Study

Treatments for Improving Mood in Women


Sponsor

Butler Hospital

Enrollment

48 participants

Start Date

Aug 27, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

  • 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 Criteria13

  • 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

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Interventions

BEHAVIORALIntegrative Yoga & Mindful Self-Compassion training

Group Integrative Yoga \& Mindful Self-Compassion training for women with a history of interpersonal violence exposure and distress

BEHAVIORALWomen's Wellbeing Education

Group women's wellbeing education for women with a history of interpersonal violence exposure and distress


Locations(1)

Butler Hospital

Providence, Rhode Island, United States

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NCT07195019


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