Butler Hospital
Providence, Rhode Island, 02906, United States
Location status: Recruiting
NCT Number: NCT07195019
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.
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Request Info18 year–65 year
Female
Interventional
Not applicable
Providence, Rhode Island, 02906, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Women who meet criteria for the following:
Group Integrative Yoga & Mindful Self-Compassion training for women with a history of interpersonal violence exposure and distress
Group women's wellbeing education for women with a history of interpersonal violence exposure and distress
Time frame: Post intervention (month 3)
Feasibility assessed based on number of participants who remained in the intervention (retention).
Time frame: Post intervention (month 3)
The Feasibility of Intervention Measure (FIM) construct comprises four items with each item measured on a 1-5 scale. The total score range is from 4-20. Higher scores indicate greater feasibility.
Time frame: Post intervention (month 3)
The Intervention Appropriateness Measure (IAM) construct comprises four items with each item measured on a 1-5 scale. The total score range is from 4-20. Higher scores indicate greater feasibility.
Time frame: Post intervention (month 3)
The Acceptability of Intervention Measure (AIM) comprises four items with each item measured on a 1-5 scale. The total score range is from 4-20. Higher scores indicate greater feasibility.
Time frame: Post intervention (month 3)
Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.
Time frame: Post intervention (month 3)
Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.
Time frame: Baseline to post intervention (month 3)
Distress at Month 3. The DASS-21 is a 21-item measure with each item measured on a 0-3 scale, and total score conversion ranging from 0-63. Higher global scores indicate greater psychological distress.
Butler Hospital
Other
Treatments for Improving Mood in Women
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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