Yoga and Mindfulness for Psychological Distress
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Butler Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for English-speaking women aged 18-65 who have experienced interpersonal violence and are feeling distressed. They must have access to a device for video sessions, a telephone, and not be pregnant or suffering from certain mental health conditions like current mania or severe substance use disorder.Inclusion Criteria
Speak and understand English well enough to understand questionnaires when read aloud
Have access to a device that will support use of the video platform used for assessments and home practice yoga video sessions
Report having experienced interpersonal violence confirmed with the Trauma History Questionnaire (THQ)
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Exclusion Criteria
Pregnancy
Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
Lifetime history of psychotic disorders (DIAMOND)
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Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo 12 weeks of integrative yoga and mindful self-compassion training or women's wellbeing education
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Integrative Yoga & Mindful Self-Compassion training
- Women's Wellbeing Education
Trial Overview The study compares an integrative yoga and mindful self-compassion program with a women's wellbeing education program to see which is better at reducing psychological distress in women with a history of interpersonal violence.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Integrative Yoga and Mindful Self-Compassion (I-YMSC) trainingExperimental Treatment1 Intervention
12 weeks of I-YMSC training
Group II: Women's Wellbeing Education (WWE)Active Control1 Intervention
12 weeks of group WWE
Find a Clinic Near You
Who Is Running the Clinical Trial?
Butler Hospital
Lead Sponsor
Trials
133
Recruited
16,700+
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Trials
886
Recruited
677,000+
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