Treatments for Improving Mood in Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Women who meet criteria for the following:
- •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
- •Non-stable course of psychiatric treatments (medication, psychotherapy) for the last 8 weeks
- •Plan to move from the area in the next 6 months, as this may preclude study participation given enrollment timeframes
- •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
- •Current weekly yoga practice or current participation in mindfulness-based programming, as these are the study interventions
结局指标
主要结局
Feasibility
时间窗: Post intervention (month 3)
Feasibility assessed based on number of participants who remained in the intervention (retention).
Feasibility of Intervention Measure
时间窗: 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.
Intervention Appropriateness Measure
时间窗: 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.
Acceptability of Intervention Measure
时间窗: 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.
The Client Satisfaction Questionnaire (CSQ-8)
时间窗: 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.
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
时间窗: 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.
次要结局
- Depression Anxiety and Stress Scale (DASS-21)(Baseline to post intervention (month 3))