Clinical trial NCT06657950: Treatments for Improving Mood in Women Survivors of Interpersonal Violence: A Community-Engaged Study-1.2
Official title: Adaptation and Pilot Study of Integrative Yoga and Mindful Self-Compassion (I-YMSC) to Improve Mood in Women Survivors of Interpersonal Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distress
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-10-26
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Feasibility
timeFrame: Post intervention (month 3)
measure: Feasibility of Intervention Measure
timeFrame: Post intervention (month 3)
measure: Intervention Appropriateness Measure
timeFrame: Post intervention (month 3)
measure: Acceptability of Intervention Measure
timeFrame: Post intervention (month 3)
measure: The Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post intervention (month 3)
measure: Home Practice Questionnaire
timeFrame: Weekly
measure: Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
timeFrame: Mid intervention (month 1.5) and Post intervention (month 3)
Secondary outcomes:
measure: Depression Anxiety and Stress Scale (DASS-21)
timeFrame: Post intervention (month 3)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References: