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

NCT05227794 | Completed DMC

• 1 other identifier: 2000031780
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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 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 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 Happiness on the 7-point Subjective Happiness Scale (SHS) at Week 10 (Post-Test)

  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)

  Baseline and Week 10

Other Outcomes (15)

• Change from Baseline in Self-Compassion on the 5-point Self-Compassion-Scale (SCS) at Week 10 (Post-Test)

  Baseline and Week 10

• Change from Baseline in Other-Oriented Compassion on the 5-point Sussex Oxford Compassion Scale for Others (SOCS-O) at Week 10 (Post-Test)

  Baseline and Week 10

• Change from Baseline in Mindfulness on the 5-point Five-Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) at Week 10 (Post-Test)

  Baseline and Week 10

Study Arms (3)

Compassion-Based Intervention

EXPERIMENTAL

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)

Mindfulness-Based Intervention

EXPERIMENTAL

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)

Waitlist Control (WL)

NO INTERVENTION

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.

Interventions

Compassion Cultivation Training (CCT) BEHAVIORAL

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.

Also known as: CCT

Compassion-Based Intervention

Mindfulness-Based Stress Reduction (MBSR) BEHAVIORAL

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.

Also known as: MBSR

Mindfulness-Based Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Enrollment of participants who identify as female will be capped at n = 180 out N = 360 (50%).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Center for Emotional Intelligence

New Haven, Connecticut, 06511, United States

Location

Related Publications (31)

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Related Links

• Compassion Cultivation Training

MeSH Terms

Conditions

Anxiety Disorders; Depression; Burnout, Psychological; Emotional Regulation; Psychological Well-Being

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Stress, Psychological; Self-Control; Social Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Marc Brackett, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• James Floman, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: February 16, 2022
• Primary Completion: May 2, 2022
• Study Completion: December 12, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)