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

NCT ID: NCT06657950

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2025-05-30

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.

Conditions

Distress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental: Integrative hatha yoga and mindful self-compassion

12 weeks of adapted, integrative yoga and mindful self-compassion specifically designed to be administered to women survivors of interpersonal violence.

Group Type: EXPERIMENTAL

Integrative hatha yoga and mindful self-compassion

Intervention Type: BEHAVIORAL

12 weeks of integrative hatha yoga and mindful self-compassion training

Interventions

Integrative hatha yoga and mindful self-compassion

12 weeks of integrative hatha yoga and mindful self-compassion training

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

K23AT011917

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2203-003 Open

Identifier Type: -

Identifier Source: org_study_id