Clinical trial NCT05227794: Compassion Training and Mindfulness Training for Social Well-Being and Mental Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Stress
Burnout
Emotion Regulation
Social Acceptance
Loneliness
Compassion
Keywords: Mindfulness-Based Stress Reduction
Compassion Cultivation Training
Online Intervention
Undergraduate Students
Randomized Controlled Trial
Health Equity
Psychological Well-Being
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A three-arm randomized controlled trial will be conducted with eligible participants allocated to one of three parallel groups based on blinded randomization procedures (ratio of 1:1:1): 1) Compassion Cultivation Training (CCT), 2) Mindfulness-Based Stress Reduction (MBSR), and 3) Waitlist Control (WL). Randomization will take place after baseline assessment, so condition assignment does not influence pre-test data.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Currently enrolled as a full-time Yale College undergraduate student

Exclusion Criteria:

* 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 = 180.
* Participants will not be excluded based on any other demographic characteristics.

Primary outcomes:
measure: Change from Baseline in Loneliness on the 4-point UCLA-Loneliness Scale Short-Form (LS-SF) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Social Connectedness on the 6-point Social Connectedness Scale-Revised (SCS-R) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Perceived Social Support on the 5-point Medical Outcomes Study-Social Support Survey (MOS-SSS) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
Secondary outcomes:
measure: Change from Baseline in Perceived Stress on the 5-point Perceived Stress Scale (PSS) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: 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)
timeFrame: Baseline and Week 10
measure: 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)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Happiness on the 7-point Subjective Happiness Scale (SHS) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: 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)
timeFrame: Baseline and Week 10
measure: 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)
timeFrame: Baseline and Week 10
Other outcomes:
measure: Change from Baseline in Self-Compassion on the 5-point Self-Compassion-Scale (SCS) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Other-Oriented Compassion on the 5-point Sussex Oxford Compassion Scale for Others (SOCS-O) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Mindfulness on the 5-point Five-Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Emotion Regulation on the 5-point Cognitive Emotion Regulation Questionnaire (CERQ) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Positive and Negative Affect on the 5-point Affective Experiences Scale (AES) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Discrimination-Based Trauma on the 4-point Trauma Symptoms of Discrimination Scale (TSDS) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Daily Social Well-Being on the Latent Factor-Scored Daily Social Well-Being Index (D-SWI) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Daily Positive Mental Health on the Latent Factor-Scored Daily Positive Mental Health Index (D-PMHI) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Daily Negative Mental Health on the Latent Factor-Scored Daily Negative Mental Health Index (D-NMHI) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Peer-Rated Social Well-Being on the Latent Factor-Scored Peer-Rated Social Well-Being Index (P-SWI) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Peer-Rated Positive Mental Health on the Latent Factor-Scored Peer-Rated Positive Mental Health Index (P-PMHI) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Peer-Rated Negative Mental Health on the Latent Factor-Scored Peer-Rated Negative Mental Health Index (P-NMHI) at Week 10 (Post-Test)
timeFrame: Baseline and Week 10
measure: Change from Baseline in Social Well-Being on the Latent Factor-Scored Social Well-Being Index (SWI) at Week 22 (Post-Test)
timeFrame: Baseline and Week 22
measure: Change from Baseline in Positive Mental Health on the Latent Factor-Scored Positive Mental Index (PMHI) at Week 22 (Post-Test)
timeFrame: Baseline and Week 22
measure: Change from Baseline in Negative Mental Health on the Latent Factor-Scored Negative Mental Index (NMHI) at Week 22 (Post-Test)
timeFrame: Baseline and Week 22
Locations:
city: New Haven
country: United States
facility: Yale Center for Emotional Intelligence
state: Connecticut
Study officials:
affiliation: Yale University
name: Marc Brackett, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: James Floman, PhD
role: PRINCIPAL_INVESTIGATOR
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