NCT03229577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

July 20, 2017

Last Update Submit

March 11, 2020

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    11 Weeks

  • Emotional Intelligence Perception Skill Test

    Assesses participant ability to perceive emotions accurately

    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.

    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.

    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.

    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).

    11 Weeks

Secondary Outcomes (9)

  • Gratitude Scale

    11 Weeks

  • Self-compassion Scale

    11 Weeks

  • Life Orientation Scale

    11 Weeks

  • Brief COPE Scale

    11 Weeks

  • Creativity Performance Questions

    11 Weeks

  • +4 more secondary outcomes

Study Arms (4)

Sudarshan Kriya Yoga

EXPERIMENTAL

Sudarshan Kriya Yoga workshop is a nationally-recognized program focused on teaching yoga-based breathing techniques.

Behavioral: Sudarshan Kriya Yoga

Mindfulness-Based Stress Reduction

EXPERIMENTAL

Mindfulness-Based Stress Reduction (MBSR) is a nationally-recognized program focused on teaching mindfulness techniques.

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.

Behavioral: Emotional Intelligence

Control

NO INTERVENTION

The control group will receive no intervention.

Interventions

Yoga-based breathing program.

Sudarshan Kriya Yoga

Mindfulness program.

Also known as: MBSR
Mindfulness-Based Stress Reduction

Emotional Intelligence program.

Also known as: EI
Emotional Intelligence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Yale student.

You may not qualify if:

  • Under 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Center for Emotional Intelligence

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marc Brackett, Ph.D.

    Director, Yale Center for Emotional Intelligence

    PRINCIPAL INVESTIGATOR
  • Leilah Harouni, B.S.

    Postgraduate Research Associate, Yale Center for Emotional Intelligence

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 25, 2017

Study Start

January 15, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations