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Yale College Project Randomized Control Trial

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ClinicalTrials.gov Identifier: NCT03229577
Recruitment Status : Not yet recruiting
First Posted : July 25, 2017
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

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, 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.

Condition or disease Intervention/treatment Phase
Mental Health Wellness 1 Behavioral: Sudarshan Kriya Yoga Behavioral: Mindfulness-Based Stress Reduction Behavioral: Emotional Intelligence Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Yale College Project Randomized Control Trial
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Arm Intervention/treatment
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 Name: 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 Name: EI

No Intervention: Control
The control group will receive no intervention.



Primary Outcome Measures :
  1. Wellbeing [ Time Frame: 60 minutes ]
    Tested using thirty minute survey on Qualtrics (online survey platform), once for each of two time points.



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

Criteria: Inclusion Criteria:

  • Yale student.

Exclusion Criteria:

  • Under 18 years old.

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


Contacts
Contact: Christina M Bradley, B.S. 610-716-8113 christina.bradley@yale.edu
Contact: Emma Seppala, Ph.D. emma.seppala@yale.edu

Locations
United States, Connecticut
Yale Center for Emotional Intelligence Recruiting
New Haven, Connecticut, United States, 06511
Contact: Christina Bradley, B.S.       christina.bradley@yale.edu   
Contact: Emma Seppala, Ph.D.       emma.seppala@yale.edu   
Sub-Investigator: Christina Bradley, B.S.         
Sub-Investigator: Emma Seppala, Ph.D.         
Principal Investigator: Marc Brackett, Ph.D.         
Sponsors and Collaborators
Yale University
Investigators
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 Chair: Aljoscha Dreisoerner, M.S. Postgraduate Fellow, Yale Center for Emotional Intelligence

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: December 20, 2018
Last Verified: December 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