Integrative yoga and mindful self‑compassion for women with past interpersonal violence and distress

Treatments for Improving Mood in Women

This trial will test whether a 12-week integrative yoga and mindful self-compassion program helps women aged 18–65 with a history of interpersonal violence and elevated distress compared with a women's wellbeing education program.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Butler Hospital (Academic / other)
• Locations: 1 site (Providence, Rhode Island)
• Trial ID: NCT07195019 on ClinicalTrials.gov

What this trial studies

This is a pilot randomized controlled trial enrolling 48 women with lifetime interpersonal violence exposure and elevated distress to compare 12 weeks of integrative yoga plus mindful self-compassion training (I-YMSC) versus 12 weeks of women's wellbeing education (WWE). Participants are randomized to one of the two 12-week intervention arms and will complete study assessments over the intervention period. Eligible participants must be female, 18–65, report interpersonal violence on the Trauma History Questionnaire, have a Kessler-6 distress score >5, speak English, and have phone and video-capable device access; those unable to be physically active, pregnant, or planning surgery are excluded. The interventions include group-based instruction and home practice, with some study activities conducted via a video platform.

Who should consider this trial

Good fit: Women aged 18–65 who report a history of interpersonal violence, have elevated distress (K6 >5), can participate in physical activity, speak English, and have access to a telephone and a video-capable device are ideal candidates.

Not a fit: Women who are pregnant, medically unable to engage in physical activity, planning surgery in the next six months, or lacking required phone/video access are unlikely to be eligible or to benefit from this program.

Why it matters

Potential benefit: If successful, the program could reduce psychological distress and improve coping and wellbeing for women who have experienced interpersonal violence.

How similar studies have performed: Previous trials of yoga, mindfulness, and self-compassion interventions have shown promising reductions in distress and trauma-related symptoms, but the combined integrative I-YMSC approach in this exact form has limited prior testing.

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

Where this trial is running

Providence, Rhode Island

• Butler Hospital — Providence, Rhode Island, United States (Recruiting)

Conditions Distress, Psychological