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NCT Number: NCT07195019

Women's Wellbeing Study

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location status: Recruiting

Location contact

Research Coordinator

CONTACT

[email protected]

401-455-6200, ext. 21070

About this study

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 education (WWE).

Participants will be women with a history of interpersonal violence exposure and heightened distress.

Participants will be randomized to Phase 2 groups of 12 weeks of I-YMSC or WWE. Forty-eight women will be enrolled.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Integrative Yoga & Mindful Self-Compassion training

Behavioral

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

Women's Wellbeing Education

Behavioral

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

Primary outcomes

  1. Feasibility

    Time frame: Post intervention (month 3)

    Feasibility assessed based on number of participants who remained in the intervention (retention).

  2. Feasibility of Intervention Measure

    Time frame: Post intervention (month 3)

    The Feasibility of Intervention Measure (FIM) construct comprises four items with each item measured on a 1-5 scale. The total score range is from 4-20. Higher scores indicate greater feasibility.

  3. Intervention Appropriateness Measure

    Time frame: Post intervention (month 3)

    The Intervention Appropriateness Measure (IAM) construct comprises four items with each item measured on a 1-5 scale. The total score range is from 4-20. Higher scores indicate greater feasibility.

  4. Acceptability of Intervention Measure

    Time frame: Post intervention (month 3)

    The Acceptability of Intervention Measure (AIM) comprises four items with each item measured on a 1-5 scale. The total score range is from 4-20. Higher scores indicate greater feasibility.

  5. The Client Satisfaction Questionnaire (CSQ-8)

    Time frame: Post intervention (month 3)

    Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.

  6. Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)

    Time frame: Post intervention (month 3)

    Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.

Secondary outcomes

  1. Depression Anxiety and Stress Scale (DASS-21)

    Time frame: Baseline to post intervention (month 3)

    Distress at Month 3. The DASS-21 is a 21-item measure with each item measured on a 0-3 scale, and total score conversion ranging from 0-63. Higher global scores indicate greater psychological distress.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Treatments for Improving Mood in Women

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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