Yale Wellness Project

March 11, 2020 updated by: Yale University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale Center for Emotional Intelligence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Criteria: Inclusion Criteria:

  • Yale student.

Exclusion Criteria:

  • Under 18 years old.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Sudarshan Kriya Yoga
Sudarshan Kriya Yoga workshop is a nationally-recognized program focused on teaching yoga-based breathing techniques.
Behavioral: Sudarshan Kriya Yoga
Yoga-based breathing program.
EXPERIMENTAL: Mindfulness-Based Stress Reduction
Mindfulness-Based Stress Reduction (MBSR) is a nationally-recognized program focused on teaching mindfulness techniques.
Behavioral: Mindfulness-Based Stress Reduction
Mindfulness program.
Other Names:
  • MBSR
EXPERIMENTAL: Emotional Intelligence
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.
Behavioral: Emotional Intelligence
Emotional Intelligence program.
Other Names:
  • EI
NO_INTERVENTION: Control
The control group will receive no intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
11 Weeks
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.
11 Weeks
Emotional Intelligence Perception Skill Test
Time Frame: 11 weeks
Assesses participant ability to perceive emotions accurately
11 weeks
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.
11 Weeks
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.
11 Weeks
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.
11 Weeks
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).
11 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gratitude Scale
Time Frame: 11 Weeks
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.
11 Weeks
Self-compassion Scale
Time Frame: 11 Weeks
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.
11 Weeks
Life Orientation Scale
Time Frame: 11 Weeks
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).
11 Weeks
Brief COPE Scale
Time Frame: 11 Weeks
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).
11 Weeks
Creativity Performance Questions
Time Frame: 11 Weeks
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.
11 Weeks
Social Connectedness Scale
Time Frame: 11 Weeks
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.
11 Weeks
One-item Self-esteem Scale
Time Frame: 11 Weeks
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.
11 Weeks
Big Five Questionnaire
Time Frame: Baseline
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).
Baseline
Human Wellbeing Scale
Time Frame: 11 Weeks
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.
11 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc Brackett, Ph.D., Director, Yale Center for Emotional Intelligence
  • Study Chair: Leilah Harouni, B.S., Postgraduate Research Associate, Yale Center for Emotional Intelligence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000020302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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