Women's Wellbeing Study

NCT ID: NCT07195019

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-27
• Study Completion Date: 2027-05-31

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.

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 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.

Conditions

Distress, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

12 weeks of I-YMSC training

Group Type: EXPERIMENTAL

Integrative Yoga & Mindful Self-Compassion training

Intervention Type: BEHAVIORAL

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

Women's Wellbeing Education (WWE)

12 weeks of group WWE

Group Type: ACTIVE_COMPARATOR

Women's Wellbeing Education

Intervention Type: BEHAVIORAL

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

Interventions

Integrative Yoga & Mindful Self-Compassion training

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

Intervention Type: BEHAVIORAL

Women's Wellbeing Education

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Female

2. Ages 18-65

3. Report having experienced interpersonal violence (defined to include all forms throughout the lifespan, confirmed with the Trauma History Questionnaire (THQ])

4. Report being distressed, defined by a score of >5 on the Kessler-6 screener

5. Speak and understand English well enough to understand questionnaires when they are read aloud

6. Have access to a telephone through owning one, a relative/friend, or an agency

7. 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

1. Inability to be physically active, determined by a score >1 on the Physical Activity Readiness Questionnaire (PAR-Q) and physician non-consent of participation

2. Planned surgery in next 6 months, as this would interfere with study participation

3. Pregnancy, as yoga should be modified for pregnancy

Women who meet criteria for the following:

4. Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)

5. Lifetime history of psychotic disorders (DIAMOND)

6. Current probable severe substance use disorder (DIAMOND)

7. Current diagnosis of anorexia nervosa or history in past year (DIAMOND)

8. 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

9. Non-stable course of psychiatric treatments (medication, psychotherapy) for the last 8 weeks

10. Plan to move from the area in the next 6 months, as this may preclude study participation given enrollment timeframes

11. 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

12. Current weekly yoga practice or current participation in mindfulness-based programming, as these are the study interventions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Butler Hospital

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Research Coordinator

Role: primary

i-ymsc.study@butler.org

401-455-6200, ext. 21070

Other Identifiers

K23AT011917

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1871144-2

Identifier Type: -

Identifier Source: org_study_id