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

Not Applicable

Recruiting

• Conditions: Distress

• Registration Number: NCT06657950
• Lead Sponsor: Butler Hospital

Brief Summary

Phase 1.2: Open Trial N=15 women survivors of interpersonal violence will be enrolled into a single-arm pilot trial to test the adapted integrative hatha yoga and mindful self-compassion program.

Detailed Description

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.

Study Timeline

• Study Start: 2024-09-10
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-22
• Study First Posted: 2024-10-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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. The total score range is from 4-20. Higher scores indicate greater feasibility.
Intervention Appropriateness Measure	Post intervention (month 3)	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.
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. The total score range is from 4-20. Higher scores indicate greater feasibility.
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.
Home Practice Questionnaire	Weekly	Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire.
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)	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 Outcome Measures

Name	Time	Method
Kessler Psychological Distress Scale-6 (K6)	Post intervention (month 3)	Distress at Month 3. The K6 is a six-item measure with each item measured on a 1-5 scale, and total score conversion ranging from 0-24. Higher scores indicate greater psychological distress.

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States