Women's Wellbeing Study

NCT07195019 | Recruiting DMC

• 2 other identifiers: 1871144-2K23AT011917
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Distress, Psychological

Outcome Measures

Primary Outcomes (6)

• Feasibility

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

  Post intervention (month 3)

• Feasibility of Intervention Measure

  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.

  Post intervention (month 3)

• Intervention Appropriateness Measure

  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.

  Post intervention (month 3)

• Acceptability of Intervention Measure

  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.

  Post intervention (month 3)

• The Client Satisfaction Questionnaire (CSQ-8)

  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.

  Post intervention (month 3)

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

  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.

  Post intervention (month 3)

Secondary Outcomes (1)

• Depression Anxiety and Stress Scale (DASS-21)

  Baseline to post intervention (month 3)

Study Arms (2)

Integrative Yoga and Mindful Self-Compassion (I-YMSC) training

EXPERIMENTAL

12 weeks of I-YMSC training

Behavioral: Integrative Yoga & Mindful Self-Compassion training

Women's Wellbeing Education (WWE)

ACTIVE COMPARATOR

12 weeks of group WWE

Behavioral: Women's Wellbeing Education

Interventions

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

Integrative Yoga and Mindful Self-Compassion (I-YMSC) training

Women's Wellbeing Education BEHAVIORAL

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

Women's Wellbeing Education (WWE)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Butler Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)