Mental Health Wellness 1NCT03229577
Yale Wellness Project
A study testing Sudarshan Kriya Yoga, Mindfulness-Based Stress Reduction and Emotional Intelligence in people with Mental Health Wellness 1, run by Yale University at 1 site in United States.
Trial summary
The Yale College Emotional Intelligence project aims to highlight the beneficial impact of wellness programs for Yale students. The investigators will examine the benefits of 3 empirically-validated programs (Emotional Intelligence, Mindfulness-Based Stress Reduction (MBSR) \& SKY Yoga Breathing) for Yale students on… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Sudarshan Kriya Yoga, Mindfulness-Based Stress Reduction and Emotional Intelligence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 30 Nov 2019
- 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
None listed.
Who cannot join
- Under 18 years old.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Center for Emotional Intelligence
New Haven, Connecticut, 06511
About this study
Official title: Yale Wellness Project Randomized Controlled Trial
The Yale College Emotional Intelligence project aims to highlight the beneficial impact of wellness programs for Yale students. The investigators will examine the benefits of 3 empirically-validated programs (Emotional Intelligence, Mindfulness-Based Stress Reduction (MBSR) \& SKY Yoga Breathing) for Yale students on measures of general well-being (e.g. perceived stress, gratitude etc). The study will also include a no-treatment control group as a comparative measure to the well-being programs. The goal of the study is to show how each program benefits student well-being over time. Pre-intervention and post-intervention data will be collected. The hypothesis is that all 3 workshops will decrease stress and improve well-being and that the manner in which each workshop will do so may be different (e.g. MBSR will benefit student well-being by increasing mindfulness and self-compassion whereas Emotional Intelligence may benefit student well-being by improving cognitive emotion regulation). Given the current state of mental health challenges and stress on college campuses, the goal of this randomized-controlled trial is to strengthen the literature on wellness programs for students and to show that student well-being can significantly increase through effective interventions.
- Conditions
- Mental Health Wellness 1
- Being tested
- Sudarshan Kriya Yoga, Mindfulness-Based Stress Reduction, Emotional Intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sudarshan Kriya YogaBehavioural
Yoga-based breathing program.
Mindfulness-Based Stress ReductionBehavioural
Also called MBSR
Mindfulness program.
Emotional IntelligenceBehavioural
Also called EI
Emotional Intelligence program.
| Study group | Role | What they receive |
|---|---|---|
| Sudarshan Kriya Yoga | Experimental | Sudarshan Kriya Yoga workshop is a nationally-recognized program focused on teaching yoga-based breathing techniques. Receives: Behavioral: Sudarshan Kriya Yoga |
| Mindfulness-Based Stress Reduction | Experimental | Mindfulness-Based Stress Reduction (MBSR) is a nationally-recognized program focused on teaching mindfulness techniques. Receives: Behavioral: Mindfulness-Based Stress Reduction |
| Emotional Intelligence | Experimental | Emotional Intelligence is a program developed for university students that focuses on teaching the skills of emotional intelligence such as labeling, understanding, and regulating emotions. Receives: Behavioral: Emotional Intelligence |
| Control | No intervention | The control group will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood and Anxiety Symptom Questionnaire Short Form
The MASQ-Short contains 30 questions with three subscales that measure: general distress, depressive symptoms, and anxious symptoms. All individual items are rated on a scale 1 to 5, where 1 indicates the individual has not felt this way at all during the past week and 5 indicates that they have felt this way extremely. The total possible score for the scale is 150 and the minimum is 30. The three sub scales are totaled together to create the total score (each contains 10 questions). The minimum and maximum scores for the subscales are 10 and 50 respectively.
Measured: 11 Weeks
Perceived Stress Scale
The 10-item Perceived Stress Scale (Cohen, S., Kamarck, T., and Mermelstein, R., 1983) 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 month, 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 month, how often have you felt that things were going your way?" Responses range from 0=never to 4=very often. The minimum and maximum scores are 0 and 40 respectively.
Measured: 11 Weeks
Emotional Intelligence Perception Skill Test
Assesses participant ability to perceive emotions accurately
Measured: 11 weeks
Satisfaction with Life Scale
The Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, \& Griffin, 1985) will be used to test participants satisfaction with their lives. This scale is 5-items and is rated on a 7 point scale from 1 (strongly disagree) to 7 (strongly agree). Examples of items include, "The conditions of my life are excellent" and " If I could live my life over, I would change almost nothing". The minimum and maximum total scores are 5 and 35 respectively.
Measured: 11 Weeks
Five Facet Mindfulness Questionnaire
Five Facet Mindfulness Questionnaire - 15-item, (FFMQ-15; Baer et al., 2008) is a 15 item measure of mindfulness that participants rate on a scale from 1 - 5 depending on how much they agree with the statement. Low scores indicate low mindfulness and high scores indicate high levels of mindfulness. Minimum and maximum scores are 15 and 75 respectively.
Measured: 11 Weeks
Ryff Scales for Psychological Wellbeing
Psychological Well-Being Scale-18 (Ryff, 2008) is an 18-item form to assess psychological wellbeing. Items are rated on a 7-point scale from strongly disagree to strongly agree. Low scores indicate poor psychological wellbeing while high scores indicate healthy psychological wellbeing. Total scores range from 18 to 126.
Measured: 11 Weeks
Burnout
The Single-item Measure of Burnout (Rohland, Kruse, \& Rohrer, 2004) will be used to measure student burnout. This measure only contains one item: "Overall, based on your definition of burnout, how would you rate your level of burnout?" Participants are asked to choose one answer ranging from 1 (I enjoy my work. I have no symptoms of burnout) to 5 (I feel completely burned out and often wonder if I can go on. I am at the point where I may need some changes or may need to seek some sort of help).
Measured: 11 Weeks
Secondary outcomes (9)
Gratitude Scale
The Gratitude Questionnaire-Six Item Form (GQ-6; McCullough, Emmons, \& Tsang, 2002) is a 6-item measure to test a participant amount of gratitude that they feel. The items are rated on a scale from 1 to 7, 1 (strongly disagree) to 7 (strongly agree). Examples of items include, "I have so much in my life to be thankful for" and "Long amounts of time can go by before I feel grateful to something or someone." Low scores indicate low gratitude and high scores indicate high gratitude. Total scores range from 6 to 42.
Measured: 11 Weeks
Self-compassion Scale
The 12 item Self-Compassion-Short Form assess self-reported self-compassion. Responses are given on a five-point scale from "Almost Never" to "Almost Always." Low scores indicate low self-compassion and high scores indicate high self-compassion. Scores range from 12 to 60.
Measured: 11 Weeks
Life Orientation Scale
The Life Orientation Test- Revised (LOT-R; Scheier, Carver, \& Bridges, 1994) will be used to measure the optimism of students. This test includes 10 items rated on a 5 point scale from 1 ( I disagree a lot) to 5 (I agree a lot). Examples of items include, " If something can go wrong for me, it will" and "In uncertain times, I usually expect the best." Scores range from low optimism (10) to high optimism (50).
Measured: 11 Weeks
Brief COPE Scale
Brief COPE (Carver, 1997) is a 28-item survey for measuring what emotion regulation strategies people use to deal with stressful situations. Participatns are asked to answer questions on a scale from 1 - 4. Low scores of emotion regulation ability (28) to high scores of emotion regulation ability (112).
Measured: 11 Weeks
Creativity Performance Questions
Assesses creativity using performance metrics. Students are asked to come up with as many creative solutions to a prompt over the course of 1.5 minutes. Responses are coded for uniqueness and breadth.
Measured: 11 Weeks
Social Connectedness Scale
This scale consists of 10 positively worded and 10 negatively worded items. The 10 new positively worded items capture experiencing a sense 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." The 10 negatively worded items capture one's experience of distance and isolation from others, for example, "I see myself as a loner" and "I feel like an outsider." Items are rated on a 6-point Likert-type scale ranging from "Strongly disagree" to "Strongly agree." Low scores (20) indicate low social connectedness while high scores (80) indicate high school connectedness.
Measured: 11 Weeks
One-item Self-esteem Scale
Single Item Self-Esteem Scale (SISE; Robins, Hendin, \& Trzesniewski, 2001) is a single item measure of the construct of self-esteem that has been validated against the well-known Rosenberg Self-Esteem Scale. Scores range from 1 - 5 with low self-esteem indicated by a score of 1.
Measured: 11 Weeks
Big Five Questionnaire
The Big Five Inventory is a 44 item self-report measure for assessing the basic personality dimensions of extraversion (e.g., "talkative"), agreeableness (e.g., "helpful and unselfish with others"), conscientiousness ("does things carefully and completely"), neuroticism, and openness to experience (e.g., "original, comes up with new ideas"; Soto, John, Gosling, \& Potter, 2008). Respondents rate the extent to which they agree with self-descriptive statements using a 1 ("strongly disagree") to 5 ("strongly agree") response scale. A total score is not created for this measure. Rather, sub scale scores are created. Ranges of scores: extraversion (8-40), agreeableness (9-45), conscientiousness (9-45), neuroticism (8-40), and openness (10-50).
Measured: Baseline
Human Wellbeing Scale
This scale is a 36-item scale where participants report how often they feel a specific list of emotions. Low scores indicate low wellbeing and high scores indicate high wellbeing. Choices range from 1-5 and scores range from 36 to 180.
Measured: 11 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start15 Jan 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Brackett, Ph.D., Principal investigator, Director, Yale Center for Emotional IntelligenceLeilah Harouni, B.S., Study chair, Postgraduate Research Associate, Yale Center for Emotional Intelligence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229577
- Sponsor's protocol ID
- 2000020302
- Status last verified
- Mar 2020
- First submitted
- 20 Jul 2017
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yale Wellness Project Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03229577
- Acronym / sponsor ID
- 2000020302
- Conditions
- Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 25 Jul 2017 (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.
The Yale College Emotional Intelligence project aims to highlight the beneficial impact of wellness programs for Yale students. The investigators will examine the benefits of 3 empirically-validated programs (Emotional Intelligence, Mindfulness-Based Stress Reduction (MBSR) \& SKY Yoga Breathing) for Yale students on measures of general well-being (e.g. perceived stress, gratitude etc). The study will also include a no-treatment control group as a comparative measure to the well-being programs. The goal of the study is to show how each program benefits student well-being over time. Pre-intervention and post-intervention data will be collected. The hypothesis is that all 3 workshops will decrease stress and improve well-being and that the manner in which each workshop will do so may be different (e.g. MBSR will benefit student well-being by increasing mindfulness and self-compassion whereas Emotional Intelligence may benefit student well-being by improving cognitive emotion regulation). Given the current state of mental health challenges and stress on college campuses, the goal of this randomized-controlled trial is to strengthen the literature on wellness programs for students and to show that student well-being can significantly increase through effective interventions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sudarshan Kriya Yoga | Experimental | Behavioral: Sudarshan Kriya YogaSudarshan Kriya Yoga workshop is a nationally-recognized program focused on teaching yoga-based breathing techniques. |
| Mindfulness-Based Stress Reduction | Experimental | Behavioral: Mindfulness-Based Stress ReductionMindfulness-Based Stress Reduction (MBSR) is a nationally-recognized program focused on teaching mindfulness techniques. |
| Emotional Intelligence | Experimental | Behavioral: Emotional IntelligenceEmotional Intelligence is a program developed for university students that focuses on teaching the skills of emotional intelligence such as labeling, understanding, and regulating emotions. |
| Control | No intervention | –The control group will receive no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Under 18 years old.
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 |
|---|---|---|
| Sudarshan Kriya YogaYoga-based breathing program. | Behavioural | Sudarshan Kriya Yoga |
| Mindfulness-Based Stress ReductionAlso: MBSRMindfulness program. | Behavioural | Mindfulness-Based Stress Reduction |
| Emotional IntelligenceAlso: EIEmotional Intelligence program. | Behavioural | Emotional Intelligence |
Primary outcome
Mood and Anxiety Symptom Questionnaire Short Form
Time frame: 11 Weeks
The MASQ-Short contains 30 questions with three subscales that measure: general distress, depressive symptoms, and anxious symptoms. All individual items are rated on a scale 1 to 5, where 1 indicates the individual has not felt this way at all during the past week and 5 indicates that they have felt this way extremely. The total possible score for the scale is 150 and the minimum is 30. The three sub scales are totaled together to create the total score (each contains 10 questions). The minimum and maximum scores for the subscales are 10 and 50 respectively.
Perceived Stress Scale
Time frame: 11 Weeks
The 10-item Perceived Stress Scale (Cohen, S., Kamarck, T., and Mermelstein, R., 1983) 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 month, 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 month, how often have you felt that things were going your way?" Responses range from 0=never to 4=very often. The minimum and maximum scores are 0 and 40 respectively.
Emotional Intelligence Perception Skill Test
Time frame: 11 weeks
Assesses participant ability to perceive emotions accurately
Satisfaction with Life Scale
Time frame: 11 Weeks
The Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, \& Griffin, 1985) will be used to test participants satisfaction with their lives. This scale is 5-items and is rated on a 7 point scale from 1 (strongly disagree) to 7 (strongly agree). Examples of items include, "The conditions of my life are excellent" and " If I could live my life over, I would change almost nothing". The minimum and maximum total scores are 5 and 35 respectively.
Five Facet Mindfulness Questionnaire
Time frame: 11 Weeks
Five Facet Mindfulness Questionnaire - 15-item, (FFMQ-15; Baer et al., 2008) is a 15 item measure of mindfulness that participants rate on a scale from 1 - 5 depending on how much they agree with the statement. Low scores indicate low mindfulness and high scores indicate high levels of mindfulness. Minimum and maximum scores are 15 and 75 respectively.
Ryff Scales for Psychological Wellbeing
Time frame: 11 Weeks
Psychological Well-Being Scale-18 (Ryff, 2008) is an 18-item form to assess psychological wellbeing. Items are rated on a 7-point scale from strongly disagree to strongly agree. Low scores indicate poor psychological wellbeing while high scores indicate healthy psychological wellbeing. Total scores range from 18 to 126.
Burnout
Time frame: 11 Weeks
The Single-item Measure of Burnout (Rohland, Kruse, \& Rohrer, 2004) will be used to measure student burnout. This measure only contains one item: "Overall, based on your definition of burnout, how would you rate your level of burnout?" Participants are asked to choose one answer ranging from 1 (I enjoy my work. I have no symptoms of burnout) to 5 (I feel completely burned out and often wonder if I can go on. I am at the point where I may need some changes or may need to seek some sort of help).
9 secondary outcomes
Gratitude Scale
Time frame: 11 Weeks
Self-compassion Scale
Time frame: 11 Weeks
Life Orientation Scale
Time frame: 11 Weeks
Brief COPE Scale
Time frame: 11 Weeks
Creativity Performance Questions
Time frame: 11 Weeks
Social Connectedness Scale
Time frame: 11 Weeks
One-item Self-esteem Scale
Time frame: 11 Weeks
Big Five Questionnaire
Time frame: Baseline
Human Wellbeing Scale
Time frame: 11 Weeks
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 Mar 2020.
- 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, Ph.D. principal investigator
Director, Yale Center for Emotional Intelligence
Leilah Harouni, B.S. study chair
Postgraduate Research Associate, Yale Center for Emotional Intelligence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sudarshan Kriya Yoga, Mindfulness-Based Stress Reduction and Emotional Intelligence in people with Mental Health Wellness 1, 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 0 inclusion and 1 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 Mar 2020. 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?
Mood and Anxiety Symptom Questionnaire Short Form (time frame: 11 Weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2020; AzTrials last refreshed its copy on 3 Nov 2026.