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Yale College Project Randomized Control Trial

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ClinicalTrials.gov Identifier: NCT03229577
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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, KORU Mindfulness & YESplus 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 (immediately after the workshop and 1 month out from the workshop). 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. KORU will benefit student well-being by increasing mindfulness and self-compassion whereas Emotional Intelligence may benefit student well-being by improving cognitive emotion regulation). In addition to the self-report measures, the study will measure physiological outcomes of stress, heart rate variability, and sleep using a wearable device (Firstbeat). Given the current state of mental health challenges and stress on college campuses, the goal of this randomized-control trial is to strengthen the literature on wellness programs for students and to show that student well-being can significantly increase through effective interventions.

Condition or disease Intervention/treatment
Mental Health Wellness 1 Behavioral: YESplus Behavioral: KORU Behavioral: Emotional Intelligence

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Yale College Project Randomized Control Trial
Actual Study Start Date : September 18, 2017
Primary Completion Date : December 8, 2017
Study Completion Date : December 10, 2017
Arms and Interventions

Arm Intervention/treatment
Experimental: YESplus
YESplus is a nationally-recognized program developed for university students that focuses on teaching yoga-based breathing techniques.
Behavioral: YESplus
Yoga-based breathing program.
Experimental: KORU
KORU is a nationally-recognized program developed for university students that focused on teaching mindfulness techniques.
Behavioral: KORU
Mindfulness program.
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.
No Intervention: Control
The control group will receive no intervention.


Outcome Measures

Primary Outcome Measures :
  1. Heart Rate Variability [ Time Frame: 24 hours ]
    Tested using FirstBeat heart rate monitors that participants will wear for 24 hours once for each of three time points.

  2. Stress Response [ Time Frame: 24 hours ]
    Tested using FirstBeat heart rate monitors that participants will wear for 24 hours once for each of three time points.


Secondary Outcome Measures :
  1. Wellbeing [ Time Frame: 30 minutes ]
    Tested using thirty minute survey on Qualtrics (online survey platform), once for each of three time points.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Criteria: Inclusion Criteria:

  • Yale student.

Exclusion Criteria:

  • Under 18 years old.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229577


Locations
United States, Connecticut
Yale Center for Emotional Intelligence
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Marc Brackett Director, Yale Center for Emotional Intelligence
More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03229577     History of Changes
Other Study ID Numbers: 2000020302
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No