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

Yale University

Status: Completed

Conditions: Compassion; Social Acceptance; Burnout; Loneliness; Emotion Regulation; Depression; Anxiety; Stress

Treatments: Behavioral: Compassion Cultivation Training (CCT); Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Study type: Interventional

Funder types: Other

Identifiers

NCT05227794

2000031780

Details and patient eligibility

About

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.

Full 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.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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290 participants in 3 patient groups

Compassion-Based Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Compassion Cultivation Training (CCT)

Mindfulness-Based Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Waitlist Control (WL)

No Intervention group

Description:

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.