Recruiting

Integrative Yoga & Mindful Self-Compassion

Sponsor:

Butler Hospital

Code:

NCT07195019

Conditions

Distress, Psychological

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Integrative Yoga & Mindful Self-Compassion training

Women's Wellbeing Education

Study Details

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

Study ID

NCT07195019

Start date

Aug 27, 2025

Status verified date

Sep, 2025

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

12 weeks of I-YMSC training

active comparator: Women's Wellbeing Education (WWE)

12 weeks of group WWE

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

Women's Wellbeing Education

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

Primary outcome measure

  • Feasibility [ Time Frame: Post intervention (month 3) ]
  • Feasibility of Intervention Measure [ Time Frame: Post intervention (month 3) ]
  • Intervention Appropriateness Measure [ Time Frame: Post intervention (month 3) ]
  • Acceptability of Intervention Measure [ Time Frame: Post intervention (month 3) ]
  • The Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Post intervention (month 3) ]
  • Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) [ Time Frame: Post intervention (month 3) ]

Central Contacts and Locations

Locations

Butler Hospital

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

More Information

Sponsor

Butler Hospital

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Butler Hospital on 2025-09-26.