Yale Wellness Project

Mental Health Wellness 1 Clinical Trial

Official title:

Yale Wellness Project Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03229577
• Other study ID #: 2000020302
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Criteria: Inclusion Criteria:

• Yale student.

Exclusion Criteria:

• Under 18 years old.

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

Behavioral:
• Sudarshan Kriya Yoga
Yoga-based breathing program.
• Mindfulness-Based Stress Reduction
Mindfulness program.
• Emotional Intelligence
Emotional Intelligence program.

Locations

Country	Name	City	State
United States	Yale Center for Emotional Intelligence	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Emotional Intelligence Perception Skill Test	Assesses participant ability to perceive emotions accurately	11 weeks
Primary	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
Primary	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
Primary	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
Primary	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	Gratitude Scale	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
Secondary	Self-compassion Scale	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
Secondary	Life Orientation Scale	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
Secondary	Brief COPE Scale	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
Secondary	Creativity Performance Questions	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
Secondary	Social Connectedness Scale	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
Secondary	One-item Self-esteem Scale	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
Secondary	Big Five Questionnaire	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
Secondary	Human Wellbeing Scale	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