AnxietyNCT05227794

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

A study testing Compassion Cultivation Training (CCT) and Mindfulness-Based Stress Reduction (MBSR) in people with Anxiety and Depression, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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'… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Anxiety, Depression, Stress
What is being tested?: Compassion Cultivation Training (CCT) and Mindfulness-Based Stress Reduction (MBSR)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 290 participants
Where: 1 siteUnited States
Study dates: 16 Feb 2022to 12 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Currently enrolled as a full-time Yale College undergraduate student

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Yale Center for Emotional Intelligence
New Haven, Connecticut, 06511

Other trials in United States

About this study

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 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.

Read the 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.

Conditions: Anxiety, Depression, Stress, Burnout, Emotion Regulation, Social Acceptance
Being tested: Compassion Cultivation Training (CCT), Mindfulness-Based Stress Reduction (MBSR)
Keywords: Mindfulness-Based Stress Reduction, Compassion Cultivation Training, Online Intervention, Undergraduate Students, Randomized Controlled Trial, Health Equity, Psychological Well-Being
Medical subject headings: Anxiety Disorders, Depression, Burnout, Psychological, Emotional Regulation, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Compassion Cultivation Training (CCT)Behavioural
Also called CCT
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.
Mindfulness-Based Stress Reduction (MBSR)Behavioural
Also called MBSR
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.

Study groups in NCT05227794
Study group	Role	What they receive
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. Receives: 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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: 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)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline and Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 202212 Dec 2022

First posted7 Feb 2022
Study start16 Feb 2022
Primary completion2 May 2022
Study completion12 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (31)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Outcomes assessor
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05227794
Sponsor's protocol ID: 2000031780
Status last verified: Feb 2023
First submitted: 26 Jan 2022
Last updated: 13 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lipson SK, Lattie EG, Eisenberg D. Increased Rates of Mental Health Service Utilization by U.S. College Students: 10-Year Population-Level Trends (2007-2017). Psychiatr Serv. 2019 Jan 1;70(1):60-63. doi: 10.1176/appi.ps.201800332. Epub 2018 Nov 5.
PubMed 30394183
Wang X, Hegde S, Son C, Keller B, Smith A, Sasangohar F. Investigating Mental Health of US College Students During the COVID-19 Pandemic: Cross-Sectional Survey Study. J Med Internet Res. 2020 Sep 17;22(9):e22817. doi: 10.2196/22817.
PubMed 32897868
Kirby JN. Compassion interventions: The programmes, the evidence, and implications for research and practice. Psychol Psychother. 2017 Sep;90(3):432-455. doi: 10.1111/papt.12104. Epub 2016 Sep 24.
PubMed 27664071
Kirby JN, Tellegen CL, Steindl SR. A Meta-Analysis of Compassion-Based Interventions: Current State of Knowledge and Future Directions. Behav Ther. 2017 Nov;48(6):778-792. doi: 10.1016/j.beth.2017.06.003. Epub 2017 Jun 21.
PubMed 29029675
Goldin, P. R., & Jazaieri, H. (2017). The compassion cultivation training (CCT) program. In E. M. Seppala, E. Simon-Thomas, S. L. Brown, M. C. Worline, C. D. Cameron, & J. R. Doty (Eds.), The Oxford Handbook of Compassion Science (pp. 235-245). Oxford University Press.
Goldberg SB, Riordan KM, Sun S, Davidson RJ. The Empirical Status of Mindfulness-Based Interventions: A Systematic Review of 44 Meta-Analyses of Randomized Controlled Trials. Perspect Psychol Sci. 2022 Jan;17(1):108-130. doi: 10.1177/1745691620968771. Epub 2021 Feb 16.
PubMed 33593124
Kabat-Zinn, J. (2003). Mindfulness-based stress reduction (MBSR). Constructivism in the Human Sciences, 8(2), 73.
Kabat-Zinn, J. (2013). Full catastrophe living, revised edition: how to cope with stress, pain and illness using mindfulness meditation. Hachette, UK.
Sedlmeier P, Eberth J, Schwarz M, Zimmermann D, Haarig F, Jaeger S, Kunze S. The psychological effects of meditation: a meta-analysis. Psychol Bull. 2012 Nov;138(6):1139-71. doi: 10.1037/a0028168. Epub 2012 May 14.
PubMed 22582738
Sedlmeier, P., Loße, C. & Quasten, L.C. (2018). Psychological effects of meditation for healthy practitioners: an update. Mindfulness 9, 371-387. https://doi.org/10.1007/s12671-017-0780-4
Sun S, Goldberg SB, Loucks EB, Brewer JA. Mindfulness-based interventions among people of color: A systematic review and meta-analysis. Psychother Res. 2022 Mar;32(3):277-290. doi: 10.1080/10503307.2021.1937369. Epub 2021 Jun 7.
PubMed 34098859
Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001 Apr 17;134(8):663-94. doi: 10.7326/0003-4819-134-8-200104170-00012.
PubMed 11304107
Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 Jun 1;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232. Epub 2010 Mar 24.
PubMed 20335313
Bohlmeijer E, ten Klooster PM, Fledderus M, Veehof M, Baer R. Psychometric properties of the five facet mindfulness questionnaire in depressed adults and development of a short form. Assessment. 2011 Sep;18(3):308-20. doi: 10.1177/1073191111408231. Epub 2011 May 17.
PubMed 21586480
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05227794
Acronym / sponsor ID: 2000031780
Conditions: Anxiety, Depression, Stress, Burnout, Emotion Regulation, Social Acceptance
Keywords: Mindfulness-Based Stress Reduction, Compassion Cultivation Training, Online Intervention, Undergraduate Students, Randomized Controlled Trial, Health Equity, Psychological Well-Being
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Study start: 16 Feb 2022 (actual)
Primary completion: 2 May 2022 (actual)
Study completion: 12 Dec 2022 (actual)
First posted: 7 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study Design, Aims, and Population:

Study Rationale:

Detailed description

Primary Aim and Hypotheses:

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:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
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.

Arm	Type	Receives
Compassion-Based Intervention	Experimental	Behavioral: Compassion Cultivation Training (CCT)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.
Mindfulness-Based Intervention	Experimental	Behavioral: Mindfulness-Based Stress Reduction (MBSR)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.
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Currently enrolled as a full-time Yale College undergraduate student

Key exclusion criteria (4 listed)

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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Compassion Cultivation Training (CCT)Also: CCTCCT 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.	Behavioural	Compassion-Based Intervention
Mindfulness-Based Stress Reduction (MBSR)Also: MBSRMBSR 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.	Behavioural	Mindfulness-Based Intervention

Primary outcome

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

6 secondary outcomes

Change from Baseline in Perceived Stress on the 5-point Perceived Stress Scale (PSS) at Week 10 (Post-Test)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and Week 10
Change from Baseline in Happiness on the 7-point Subjective Happiness Scale (SHS) at Week 10 (Post-Test)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and Week 10

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
Background: PubMed 30394183Lipson SK, Lattie EG, Eisenberg D. Increased Rates of Mental Health Service Utilization by U.S. College Students: 10-Year Population-Level Trends (2007-2017). Psychiatr Serv. 2019 Jan 1;70(1):60-63. doi: 10.1176/appi.ps.201800332. Epub 2018 Nov 5.
Background: PubMed 32897868Wang X, Hegde S, Son C, Keller B, Smith A, Sasangohar F. Investigating Mental Health of US College Students During the COVID-19 Pandemic: Cross-Sectional Survey Study. J Med Internet Res. 2020 Sep 17;22(9):e22817. doi: 10.2196/22817.
Background: PubMed 27664071Kirby JN. Compassion interventions: The programmes, the evidence, and implications for research and practice. Psychol Psychother. 2017 Sep;90(3):432-455. doi: 10.1111/papt.12104. Epub 2016 Sep 24.
Background: PubMed 29029675Kirby JN, Tellegen CL, Steindl SR. A Meta-Analysis of Compassion-Based Interventions: Current State of Knowledge and Future Directions. Behav Ther. 2017 Nov;48(6):778-792. doi: 10.1016/j.beth.2017.06.003. Epub 2017 Jun 21.
BackgroundGoldin, P. R., & Jazaieri, H. (2017). The compassion cultivation training (CCT) program. In E. M. Seppala, E. Simon-Thomas, S. L. Brown, M. C. Worline, C. D. Cameron, & J. R. Doty (Eds.), The Oxford Handbook of Compassion Science (pp. 235-245). Oxford University Press.
Background: PubMed 33593124Goldberg SB, Riordan KM, Sun S, Davidson RJ. The Empirical Status of Mindfulness-Based Interventions: A Systematic Review of 44 Meta-Analyses of Randomized Controlled Trials. Perspect Psychol Sci. 2022 Jan;17(1):108-130. doi: 10.1177/1745691620968771. Epub 2021 Feb 16.
BackgroundKabat-Zinn, J. (2003). Mindfulness-based stress reduction (MBSR). Constructivism in the Human Sciences, 8(2), 73.
BackgroundKabat-Zinn, J. (2013). Full catastrophe living, revised edition: how to cope with stress, pain and illness using mindfulness meditation. Hachette, UK.
Background: PubMed 22582738Sedlmeier P, Eberth J, Schwarz M, Zimmermann D, Haarig F, Jaeger S, Kunze S. The psychological effects of meditation: a meta-analysis. Psychol Bull. 2012 Nov;138(6):1139-71. doi: 10.1037/a0028168. Epub 2012 May 14.
BackgroundSedlmeier, P., Loße, C. & Quasten, L.C. (2018). Psychological effects of meditation for healthy practitioners: an update. Mindfulness 9, 371-387. https://doi.org/10.1007/s12671-017-0780-4
Background: PubMed 34098859Sun S, Goldberg SB, Loucks EB, Brewer JA. Mindfulness-based interventions among people of color: A systematic review and meta-analysis. Psychother Res. 2022 Mar;32(3):277-290. doi: 10.1080/10503307.2021.1937369. Epub 2021 Jun 7.
Background: PubMed 11304107Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001 Apr 17;134(8):663-94. doi: 10.7326/0003-4819-134-8-200104170-00012.
Compassion Cultivation TrainingLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marc Brackett, PhD principal investigator

Yale University

James Floman, PhD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Compassion Cultivation Training (CCT) and Mindfulness-Based Stress Reduction (MBSR) in people with Anxiety and Depression, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Loneliness on the 4-point UCLA-Loneliness Scale Short-Form (LS-SF) at Week 10 (Post-Test) (time frame: Baseline and Week 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05227794, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.