Compassion Training and Mindfulness Training for Social Well-Being and Mental Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anxiety, Depression, Stress, Burnout, Emotion Regulation, Social Acceptance, Loneliness, Compassion

Intervention / Treatment
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* Behavioral: Compassion Cultivation Training (CCT)
* Behavioral: Mindfulness-Based Stress Reduction (MBSR)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compassion-Based Intervention<br>Participants in this condition are assigned to an empirically supported 8-week online compassion-based intervention protocol. The intervention includes a weekly 2-hour educational session and a recommendation of 15-30-mins of daily meditation, and real-world assignments to practice compassion. | Behavioral: Compassion Cultivation Training (CCT)<br>* CCT is a secular, empirically supported 8-week program that integrates meditation practices, interactive discussions, and educational lectures to improve self-compassion and other-oriented compassion, emotion and stress management, and happiness and well-being. It includes a weekly 2-hour educational lecture with discussion and in-class exercises, a recommendation of 15-30 minutes of daily meditation, and real-world assignments to practice compassion. The program is taught by a certified instructor with more than 5 years experience.<br>* Other names: CCT;|
| Experimental: Mindfulness-Based Intervention<br>Participants in this condition are assigned to an empirically supported 8-week online mindfulness-based intervention protocol. The intervention includes a weekly 2-hour educational session, a recommendation of 15-30 minutes of daily meditation, and an optional 6-hour one-day retreat. | Behavioral: Mindfulness-Based Stress Reduction (MBSR)<br>* MBSR is among the most studied mindfulness-based interventions in the literature and is a secular, 8-week psycho-educational group-based intervention. The program structure (slightly modified to match CCT) includes a weekly 2-hour class, a prescription of 15-30-minutes of daily mindfulness practice, and a one-day optional retreat (6 hours) between week six and seven. The program is taught by a certified instructor with more than 5 years experience.<br>* Other names: MBSR;|
| No Intervention: Waitlist Control (WL)<br>The WL control group will complete all study assessments on the same schedule as the intervention arms. At the time of the final follow-up assessment, participants will be randomly assigned to one of the interventions (CCT or MBSR) with the same instructors. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Loneliness on the 4-point UCLA-Loneliness Scale Short-Form (LS-SF) at Week 10 (Post-Test) | 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) | Baseline and Week 10 | 
| Change from Baseline in Social Connectedness on the 6-point Social Connectedness Scale-Revised (SCS-R) at Week 10 (Post-Test) | 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) | Baseline and Week 10 | 
| Change from Baseline in Perceived Social Support on the 5-point Medical Outcomes Study-Social Support Survey (MOS-SSS) at Week 10 (Post-Test) | 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) | Baseline and Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Perceived Stress on the 5-point Perceived Stress Scale (PSS) at Week 10 (Post-Test) | The 14-item PSS measures the degree to which situations in one's life are appraised as stressful. Respondents report how frequently they feel stress or have difficulty coping with life stresses. Items include questions that ask about the frequency of negative experiences (e.g., In the last week, how often have you felt that you were unable to control the important things in your life?) and positive experiences (e.g., In the last week, how often have you felt that things were going your way?). Responses range from 0 = never to 4 = very often. The PSS will be used as one measure of three that will be aggregated into a single Negative Mental Health Index (NMHI) using latent variable modeling. Change = (Week 10 Score - Baseline Score) | 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) | The PROMIS-A-SF is an 8-item measure to assess symptoms of anxiety among adults. The PROMIS anxiety items focus on fear and hyperarousal. The items in the PROMIS negative affect bank use a 7-day time frame and a five-point rating scale ranging from 1 (Never) to 5 (Always). The PROMIS-A-SF will be used as one measure of three that will be aggregated into a single Negative Mental Health Index (NMHI) using latent variable modeling. Change = (Week 10 Score - Baseline Score) | 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) | The PROMIS-D-SF is an 8-item measure to assess symptoms of depression among adults. The PROMIS depression items focus on affective and cognitive manifestations of depression. The items in the PROMIS negative affect bank use a 7-day time frame and a five-point rating scale ranging from 1 (Never) to 5 (Always). The PROMIS-D-SF will be used as one measure of three that will be aggregated into a single Negative Mental Health Index (NMHI) using latent variable modeling. Change = (Week 10 Score - Baseline Score) | Baseline and Week 10 | 
| Change from Baseline in Happiness on the 7-point Subjective Happiness Scale (SHS) at Week 10 (Post-Test) | The SHS is a 4-item scale that assesses global subjective happiness. One item asks respondents to characterize themselves on happiness using absolute ratings (1 = not a very happy person to 7 = a very happy person). Another item asks respondents to provide ratings of their happiness relative to their peers (1 = less happy to 7 = more happy). The final two items offer brief descriptions of happy and unhappy individuals and ask respondents the extent to which each characterization describes them (1 = not at all to 7 = a great deal). The 4 items are averaged with higher scores reflecting greater happiness (total score range: 1 = not at all happy to 7 = very happy). The SHS will be used as one measure of three that will be aggregated into a single Positive Mental Health Index (PMHI) using latent variable modeling. Change = (Week 10 Score - Baseline Score) | Baseline and Week 10 | 
| 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) | The Positive Emotions subscale of the Modified Differential Emotions Scale (mDES) measures the frequency one experiences 10 positive emotion word triads (e.g., 'serene-content-peaceful' and 'grateful-appreciative-thankful') 'over the past 2 weeks.' A composite score for positive emotions is created by averaging across the 10 positive emotion word triad items. Responses are made on a 5-point scale: 0 = never; 1 = rarely; 2 = some of the time; 3 = often; 4 = most of the time. The Positive Emotions subscale of the mDES will be used as one measure of three that will be aggregated into a single Positive Mental Health Index (PMHI) using latent variable modeling. Change = (Week 10 Score - Baseline Score) | 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) | The Patient-Reported Outcomes Measurement Information System Meaning and Purpose Scale Short-Form (PROMIS-MP-SF) is comprised of four items. These four items are averaged to create a meaning and purpose mean score. The items are rated on a scale ranging from 1 (not at all) to 5 (very much). The PROMIS-MP-SF will be used as one measure of three that will be aggregated into a single Positive Mental Health Index (PMHI) using latent variable modeling. Change = (Week 10 Score - Baseline Score) | Baseline and Week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial, Psychological Well-Being, Mindfulness-Based Stress Reduction, Compassion Cultivation Training, Online Intervention, Undergraduate Students, Health Equity