The Yale Equity in Student Well-Being Project: The Effects of 8-Week Online Compassion Cultivation Training (CCT) and Mindfulness-Based Stress Reduction (MBSR) on Diverse University Students' Social Well-Being and Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Change from Baseline in Perceived Social Support on the 5-point Medical Outcomes Study-Social Support Survey (MOS-SSS) at Week 10 (Post-Test)
研究概览
简要总结
Study Design, Aims, and Population:
The present study is a three-arm randomized controlled trial (RCT). The primary aim is to test the relative efficacy of two 8-week online interventions - Compassion Cultivation Training (CCT) and Mindfulness-Based Stress Reduction (MBSR) - in promoting diverse university students' social well-being (i.e., reduced loneliness, and enhanced social connectedness and perceived social support) compared to a Waitlist (WL) control group.
The secondary aim is to examine the effects of CCT versus MBSR on the mental health of diverse university students compared to the WL group. Mental health is defined in this research as both positive mental health (i.e., happiness, positive emotions, meaning and purpose) and negative mental health (i.e., stress, anxiety, and depression).
Additionally, another aim is to enroll 75% students of color and 50% male identifying students, whose social well-being and mental health is currently understudied, to better represent the sociodemographic diversity of the university student population in the literature.
Study Rationale:
The COVID-19 pandemic triggered widespread disruptions in social connections and relational bonds that robustly support a variety of mental and physical health-protective processes. University students' social well-being may have been especially impacted as universities provide a central context for socialization. At the same time, the pandemic exacerbated a pre-existing rise in cases of mental health conditions in university students. If found effective, online-based CCT and MBSR might serve as scalable psychological interventions to foster social thriving and mental health among diverse university students.
详细描述
Primary Aim and Hypotheses:
The primary aim is to study the main effects of CCT and MBSR (vs. WL, and compared to each other) on self-report measures of participant social well-being (i.e., loneliness, social connectedness, and perceived social support).
It is predicted that CCT will enhance social well-being compared to MBSR and to the WL, and that MBSR will enhance social well-being compared to the WL.
Secondary Aim and Hypotheses:
The secondary aim is to study the main effects of CCT and MBSR (vs. WL, and compared to each other) on self-report measures of participant mental health. This includes changes in positive mental health (i.e., happiness, positive emotions, and meaning and purpose) and negative mental health (i.e., stress, anxiety symptoms, and depression symptoms).
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participant Masking: Yes (partial)
Participants will not be informed of the training they are randomly assigned. However, participants assigned to the waitlist will know they are in the control group (as they will not receive any training). Thus, comparisons between CCT and MBSR will be masked, but comparisons between CCT and MBSR with the control will not.
Outcomes Assessor Masking: Yes (partial)
For all self-reported outcomes (Primary Outcomes), partial participant blinding to condition will necessarily imply partial outcomes assessor blinding. Specifically, for CCT vs. MBSR comparisons, outcomes assessor blinding for self-reports will be masked, but comparisons between CCT and MBSR with the control will not be masked. For all peer rating outcomes (Other Outcomes), full outcomes assessor blinding will be possible (peers will not know what training group participants are in).
Masking Conclusion:
Double-blinding of the trial is possible (but see the above notes).
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
- •Currently enrolled as a full-time Yale College undergraduate student
排除标准
- •Current clinical mental health condition diagnosis made by a licensed medical professional (as self-reported by participants), including: major depressive disorder, anxiety disorder, bipolar disorder, borderline personality disorder, psychotic disorder, post-traumatic stress disorder, substance use disorder, and/or self-harm/attempted suicide/suicide ideation.
- •Demographic Eligibility Criteria:
- •To enroll 75% participants of color (BIPOC) and 50% male identifying participants. Enrollment of participants who identify as White will be capped at n = 90, and participants who identify as female will be capped at n =
- •Participants will not be excluded based on any other demographic characteristics.
结局指标
主要结局
Change from Baseline in Perceived Social Support on the 5-point Medical Outcomes Study-Social Support Survey (MOS-SSS) at Week 10 (Post-Test)
时间窗: Baseline and Week 10
The MOS-SSS will be administered to measure perceived social support among college students (dropping the tangible support subscale due to lack of population relevance). Participants indicate their perceived level of current social support using a five-point Likert scale ranging from 1 (None of the time) to 5 (All of the time). The MOS-SSS will be used as one measure out of three that will be aggregated into a single Social Well-Being Index (SWI) using latent variable modeling. Change = (Week 10 Score - Baseline Score)
Change from Baseline in Loneliness on the 4-point UCLA-Loneliness Scale Short-Form (LS-SF) at Week 10 (Post-Test)
时间窗: Baseline and Week 10
The UCLA LS-SF is a 10-item short-form to measure an individual's subjective feelings of loneliness and feelings of social isolation. Participants rate each item on a four-point scale ranging from 1 (I never feel this way) to 4 (I often feel this way). The UCLA LS-SF will be used as one measure out of three that will be aggregated into a single Social Well-Being Index (SWI) using latent variable modeling. Change = (Week 10 Score - Baseline Score)
Change from Baseline in Social Connectedness on the 6-point Social Connectedness Scale-Revised (SCS-R) at Week 10 (Post-Test)
时间窗: Baseline and Week 10
The 20-items SCS-R captures students' experience of closeness with others and maintaining and seeking connections. Sample items include "I am able to connect with other people," and "I am able to relate to my peers" "I see myself as a loner" and "I feel like an outsider." Items are rated on a six-point Likert-type scale ranging from 1 = "Strongly disagree" to 6 = "Strongly agree." The SCS-R will be used as one measure out of three that will be aggregated into a single Social Well-Being Index (SWI) using latent variable modeling. Change = (Week 10 Score - Baseline Score)
次要结局
- Change from Baseline in Positive Emotions on the 5-point Positive Emotions subscale of the Modified Differential Emotions Scale (mDES) at Week 10 (Post-Test)(Baseline and Week 10)
- Change from Baseline in Perceived Stress on the 5-point Perceived Stress Scale (PSS) at Week 10 (Post-Test)(Baseline and Week 10)
- Change from Baseline in Depression on the 5-point Patient-Reported Outcomes Measurement Information System Depression Short-Form (PROMIS-D-SF) at Week 10 (Post-Test)(Baseline and Week 10)
- Change from Baseline in Meaning and Purpose on the 5-point Patient-Reported Outcomes Measurement Information System Meaning and Purpose Scale Short-Form (PROMIS-MP-SF) at Week 10 (Post-Test)(Baseline and Week 10)
- Change from Baseline in Anxiety on the 5-point Patient-Reported Outcomes Measurement Information System Anxiety Short-Form (PROMIS-A-SF) at Week 10 (Post-Test)(Baseline and Week 10)
- Change from Baseline in Happiness on the 7-point Subjective Happiness Scale (SHS) at Week 10 (Post-Test)(Baseline and Week 10)