Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 2:31 PM
Study NCT ID:
NCT05227794
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2022-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compassion Training and Mindfulness Training for Social Well-Being and Mental Health
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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).
It is predicted that CCT and MBSR will both increase positive mental health and both decrease negative mental health compared to the WL. It is hypothesized that there will be no differences between the effects of CCT and MBSR on participants' positive or negative mental health.
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).
It is predicted that CCT and MBSR will both increase positive mental health and both decrease negative mental health compared to the WL. It is hypothesized that there will be no differences between the effects of CCT and MBSR on participants' positive or negative mental health.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: