Efficacy of Three Online Well-Being Programs to Improve Work-Related Outcomes

Well-being Clinical Trial

Official title:

A Randomized Trial Examining the Impact of Three 8-week Online Well-Being Programs on Employment-Related Absenteeism, Engagement, Burnout, Stress, and Resilience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306654
• Other study ID #: 2.5
• Status: Completed
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: March 14, 2018

Study information

• Verified date: July 2018
• Source: Happify Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Participants will be randomly assigned between three well-being programs, and assessed with questionnaires before and after the 8-week program, as well as 1-month after the end of the program.

Description:

Participants will be randomly assigned between three different well-being programs, with each program lasting 8-weeks and taking place on a simplified research version of the Happify platform. Well-being programs include the unchanged Happify platform, a version of the Happify platform that is designed to engage with specific activities but does not aim to promote positive emotion or reduce negative emotion (i.e., Placebo condition), and a version of the Happify platform that encourages thinking about well-being through quizzes and polls without providing any instructions for promotion (i.e., Wait-list Control). Participants will be asked to complete questionnaires before and after the 8-week program, as well as a 1-month follow-up questionnaire after the program is complete, at which point study participation will end.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: March 14, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• No prior experience on the Happify platform (new user registration)

• Full-time employment

Exclusion Criteria:

Related Conditions & MeSH terms

• Well-being

Intervention

Behavioral:
• Happify
An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.

Locations

Country	Name	City	State
United States	Happify (an online platform -- study is entirely online)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Happify Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Carpenter J, Crutchley P, Zilca RD, Schwartz HA, Smith LK, Cobb AM, Parks AC. Seeing the "Big" Picture: Big Data Methods for Exploring Relationships Between Usage, Language, and Outcome in Internet Intervention Data. J Med Internet Res. 2016 Aug 31;18(8):e241. doi: 10.2196/jmir.5725. Erratum in: J Med Internet Res. 2017 Dec 19;19(12 ):e347. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absenteeism (Health and Performance Questionnaire, HPQ [World Health Organization (WHO), 2002])	An 8-item subset of the HPQ focusing on job absenteeism and work quality. Participants will be asked to indicate how many times in the past week they missed part of/an entire work day due to problems with their physical or mental health, and to indicate how often in the past 7 days the quality of their work suffered (e.g., how often they found themselves not working as carefully as they should).	Change from baseline to 8-week post, 1-month follow-up
Primary	Work Engagement (Utrecht Work Engagement Scale [Schaufeli et al., 2002])	A 2-item subset of the UWES focusing on job resilience and perseverance. Participants will be asked to indicate how frequently they feel mentally resilient at their job and how frequently they persevere.	Change from baseline to 8-week post, 1-month follow-up
Primary	Burnout (Maslach Burnout Inventory [Maslach & Jackson, 1981])	A 5-item subset of the MBI focusing on feeling burned out in work settings. Participants will be asked to indicate the extent to which they agree that they feel burned out (e.g., that they feel burned out from their work or feel frustrated by their job).	Change from baseline to 8-week post, 1-month follow-up
Primary	Job-Related Stress (Stress-related Presenteeism Scale [Gilbreath & Frew, 2008])	A 6-item measure of job stress-related presenteeism. Participants will be asked to indicate how frequently they suffer from stress-related presenteeism is work (e.g., they are unable to concentrate on their job at work, or stress distracts their attention away from job tasks).	Change from baseline to 8-week post, 1-month follow-up
Primary	Resilience (composite of Perceived Stress Scale [Cohen et al., 1983], Happify Scale [Carpenter et al., 2016] and Life Orientation Scale, Revised [Scheier & Carver, 1985]).	Composite score made of perceived stress, positive emotionality, and optimism. Perceived stress was measured using the Perceived Stress Scale (PSS; Cohen, Kamarck, & Mermelstein, 1983), a 10-item questionnaire that asks users to rate on a scale of 0 (never) to 4 (very often) how frequently they experience various symptoms of feeling stress. Positive emotionality was measured using the emotion subscale of the Happify Scale (HS-E; Carpenter, Crutchley, Zilca, Schwartz, Smith, Cobb, & Parks, 2016), which is a 4-item scale asking participants to rate the extent to which, over the past week, they have experienced positive and negative emotions that are activated or de-activated. Optimism was measured using the Life Orientation Scale, Revised (LOT-R; Scheier & Carver, 1985), a 6-item scale on which participants rate the extent to which they identify with optimistic or pessimistic beliefs.	Change from baseline to 8-week post, 1-month follow-up
Primary	Absenteeism (Healthy Days measure [Center for Disease Control (CDC), 2000])	A 1-item measure of the extent to which poor physical/mental health prevents one from doing their usual activities, such as self-care, work, or recreation, in the past 30 days [CDC, 2002].	Change from baseline to 8-week post, 1-month follow-up

External Links

•   Site where study is taking place