Treatments for Improving Mood in Women Survivors of Interpersonal Violence: A Community-Engaged Study-1.2

In Phase 1.2, the investigators will conduct an open single-arm pilot trial of a 12 week adapted integrative hatha yoga and self-compassion program.

The investigators will enroll 15 women survivors of interpersonal violence in the open pilot trial.

• Integrative hatha yoga and mindful self-compassion (Behavioral): 12 weeks of integrative hatha yoga and mindful self-compassion training

Primary outcomes

• Participant Retention - Feasibility [Post intervention (month 3)]: Feasibility assessed based on number of participants who remained in the intervention (retention).
• Feasibility of Intervention Measure [Post intervention (month 3)]: The Feasibility of Intervention Measure (FIM) construct comprises four items with each item measured on a 1-5 scale, constituting the score range. Higher scores indicate greater feasibility.
• Intervention Appropriateness Measure [Post intervention (month 3)]: The Intervention Appropriateness Measure (IAM) construct constitutes four items with each item measured on a 1-5 scale, comprising the total score range. Higher scores indicate greater intervention appropriateness.
• Acceptability of Intervention Measure [Post intervention (month 3)]: The Acceptability of Intervention Measure (AIM) comprises four items with each item measured on a 1-5 scale, constituting the total score range. Higher scores indicate greater acceptability.
• The Client Satisfaction Questionnaire (CSQ-8) [Post intervention (month 3)]: 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.
• Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) [Mid intervention (month 1.5) and Post intervention (month 3)]: 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.

Secondary outcomes

• Depression Anxiety and Stress Scale (DASS-21) [Post intervention (month 3)]: 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.

Sex: Female, ages: 18 Years to 65 Years

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

Participant flow

Outcome results

• Participant Retention - Feasibility (Primary), Count of participants, Participants: Experimental: Integrative Hatha Yoga and Mindful Self-compassion 9
• Feasibility of Intervention Measure (Primary), Mean, Units on a scale: Experimental: Integrative Hatha Yoga and Mindful Self-compassion 4.86 +/- 0.42
• Intervention Appropriateness Measure (Primary), Mean, Units on a scale: Experimental: Integrative Hatha Yoga and Mindful Self-compassion 4.89 +/- 0.33
• Acceptability of Intervention Measure (Primary), Mean, Units on a scale: Experimental: Integrative Hatha Yoga and Mindful Self-compassion 4.94 +/- 0.17
• The Client Satisfaction Questionnaire (CSQ-8) (Primary), Mean, Units on a scale: Experimental: Integrative Hatha Yoga and Mindful Self-compassion 31.44 +/- 1.01
• Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) (Primary), Number, Adverse events: Experimental: Integrative Hatha Yoga and Mindful Self-compassion 6
• Depression Anxiety and Stress Scale (DASS-21) (Secondary), Mean, Units on a scale: Experimental: Integrative Hatha Yoga and Mindful Self-compassion 17.78 +/- 18.45

Adverse events

Time frame: From enrollment until end of follow-up, up to 4 months

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2025-04-21)
• Informed Consent Form (PDF, 2025-01-30)

NIH grants: K23AT011917