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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):
Yale University

July 20, 2017
July 25, 2017
January 9, 2018
September 18, 2017
December 8, 2017   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
Same as current
Complete list of historical versions of study NCT03229577 on ClinicalTrials.gov Archive Site
Wellbeing [ Time Frame: 30 minutes ]
Tested using thirty minute survey on Qualtrics (online survey platform), once for each of three time points.
Same as current
Not Provided
Not Provided
 
Yale College Project Randomized Control Trial
Yale College Project Randomized Control 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, 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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Mental Health Wellness 1
  • Behavioral: YESplus
    Yoga-based breathing program.
  • Behavioral: KORU
    Mindfulness program.
  • Behavioral: Emotional Intelligence
    Emotional Intelligence program.
  • Experimental: YESplus
    YESplus is a nationally-recognized program developed for university students that focuses on teaching yoga-based breathing techniques.
    Intervention: Behavioral: YESplus
  • Experimental: KORU
    KORU is a nationally-recognized program developed for university students that focused on teaching mindfulness techniques.
    Intervention: Behavioral: KORU
  • 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.
    Intervention: Behavioral: Emotional Intelligence
  • No Intervention: Control
    The control group will receive no intervention.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
200
December 10, 2017
December 8, 2017   (Final data collection date for primary outcome measure)

Criteria: Inclusion Criteria:

  • Yale student.

Exclusion Criteria:

  • Under 18 years old.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03229577
2000020302
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Yale University
Yale University
Not Provided
Principal Investigator: Marc Brackett Director, Yale Center for Emotional Intelligence
Yale University
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP