Treatments for Improving Mood in Women Survivors of Interpersonal Violence: A Community-Engaged S… (NCT06657950) | Clinical Trial Compass
CompletedNot Applicable
Treatments for Improving Mood in Women Survivors of Interpersonal Violence: A Community-Engaged Study-1.2
United States11 participantsStarted 2024-09-10
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female
. Ages 18-65
. Report having experienced interpersonal violence (defined to include all forms throughout the lifespan, confirmed with the Trauma History Questionnaire (THQ\])
. Report being distressed, defined by a score of \>5 on the Kessler-6 screener
. Speak and understand English well enough to understand questionnaires when they are read aloud
. Have access to a telephone through owning one, a relative/friend, or an agency
. 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
. Inability to be physically active, determined by a score \>1 on the Physical Activity Readiness Questionnaire (PAR-Q) and physician non-consent of participation
. Planned surgery in next 6 months, as this would interfere with study participation
. Pregnancy, as yoga should be modified for pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participant Retention - Feasibility
Timeframe: Post intervention (month 3)
2
Feasibility of Intervention Measure
Timeframe: Post intervention (month 3)
3
Intervention Appropriateness Measure
Timeframe: Post intervention (month 3)
4
Acceptability of Intervention Measure
Timeframe: Post intervention (month 3)
5
The Client Satisfaction Questionnaire (CSQ-8)
Timeframe: Post intervention (month 3)
6
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
Timeframe: Mid intervention (month 1.5) and Post intervention (month 3)
. Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
. Lifetime history of psychotic disorders (DIAMOND)
. Current probable severe substance use disorder (DIAMOND)
. Current diagnosis of anorexia nervosa or history in past year (DIAMOND)
. 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