Women's Wellbeing Study

Butler Hospital

Status: Enrolling

Conditions: Distress, Psychological

Treatments: Behavioral: Integrative Yoga & Mindful Self-Compassion training; Behavioral: Women's Wellbeing Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07195019

1871144-2

K23AT011917 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

In Phase 2, the investigators will conduct a pilot randomized controlled trial (RCT) of 12 weeks of integrative yoga and mindful self-compassion training (I-YMSC) vs. 12 weeks of women's wellbeing education (WWE).

Participants will be women with a history of interpersonal violence exposure and heightened distress.

Participants will be randomized to Phase 2 groups of 12 weeks of I-YMSC or WWE. Forty-eight women will be enrolled.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

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

Experimental group

Description:

12 weeks of I-YMSC training

Treatment:

Behavioral: Integrative Yoga & Mindful Self-Compassion training

Women's Wellbeing Education (WWE)

Active Comparator group

Description:

12 weeks of group WWE

Treatment:

Behavioral: Women's Wellbeing Education