Women's Wellbeing Study

Treatments for Improving Mood in Women

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.

Study Overview

• Status: Recruiting
• Conditions: Distress, Psychological
• Intervention / Treatment: Behavioral: Integrative Yoga & Mindful Self-Compassion training; Behavioral: Women's Wellbeing Education

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Recruiting
      • Butler Hospital
      • Contact: Research Coordinator; Phone Number: 401-455-6200, ext. 21070; Email: i-ymsc.study@butler.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrative Yoga and Mindful Self-Compassion (I-YMSC) training; 12 weeks of I-YMSC training	Behavioral: Integrative Yoga & Mindful Self-Compassion training; Group Integrative Yoga & Mindful Self-Compassion training for women with a history of interpersonal violence exposure and distress
Active Comparator: Women's Wellbeing Education (WWE); 12 weeks of group WWE	Behavioral: Women's Wellbeing Education; Group women's wellbeing education for women with a history of interpersonal violence exposure and distress

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Anxiety and Stress Scale (DASS-21)	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.	Baseline to post intervention (month 3)

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: September 19, 2025
• First Submitted That Met QC Criteria: September 19, 2025
• First Posted (Estimated): September 26, 2025

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1871144-2; K23AT011917 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No