Dating and Sexual Violence Among Sexual Minority Women Living in Central New York (Project DAWN), Study B: Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in Blood Pressure
研究概览
简要总结
This project will test the ability of brief self-compassion training to attenuate physiological and subjective responses to induced stress among sexual minority women, transgender people, and nonbinary people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 18 years of age or older
- •Be fluent in English (i.e., speak and read English)
- •Have Internet access
- •Have a working email address
- •Self-identify sexual identity as LGBQ+ or another non-heterosexual identity AND gender identity as cisgender woman, transgender, nonbinary, or other gender minority identity
- •Currently live in Central NY
排除标准
- •Failing an inclusion criterion
- •Report having been hospitalized at an inpatient facility for psychiatric support within the past 6 months
- •Report being currently pregnant
- •Report a history of heart attack, unstable angina pectoris, heart failure, coronary heart disease, vascular, heart problems, stroke, or brain hemorrhage
- •Report being on blood pressure medication
- •Have resting systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 100 mmHg
结局指标
主要结局
Change in Blood Pressure
时间窗: Baseline, Immediate Follow-Up (40 minutes after Baseline), During TSST (45-50 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
Systolic and diastolic blood pressure will be measured with an Omron ocillometric blood pressure monitoring device before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
Change in Heart Rate Variability
时间窗: Baseline, Immediate Follow-Up (40 minutes after Baseline), During TSST (45-50 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
Heart rate variability will be measured with BIOPAC MP160 System before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
Change in Salivary Cortisol
时间窗: Baseline, Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
Salivary cortisol levels will be collected using Salimetrics saliva swabs before the intervention and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
Change in Subjective Stress
时间窗: Baseline, Immediate Follow-Up (40 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
Subjective stress reactivity will be measured with the six item State-Trait Anxiety Inventory (Marteau \& Bekker, 1993), the Positive and Negative Affect Schedule (PANAS), and three visual analog scales before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
Change in Heart Rate
时间窗: Baseline, Immediate Follow-Up (40 minutes after Baseline), During TSST (45-50 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
Heart rate will be measured with BIOPAC MP160 System before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
Change in Skin Conductance
时间窗: Baseline, Immediate Follow-Up (40 minutes after Baseline), During TSST (45-50 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
Skin conductance reactivity will be measured with the BIOPAC MP160 System before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
次要结局
- Change in PTSD Symptoms(Baseline, Follow-Up (1-month))
- Change in Substance Use(Baseline, Follow-Up (1-month))
- Change in Dissociation(Baseline, Immediate Follow-Up (40 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point))
- Change in Craving(Baseline, Immediate Follow-Up (40 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point))