NCT03306654

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

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

October 2, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

October 24, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2018

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

October 2, 2017

Last Update Submit

July 31, 2018

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

Unchanged Happify

ACTIVE COMPARATOR

Participants use Happify as it is currently available to consumers on the main site, including all engagement elements. Users may access a wide variety of 4-week programs and use them in any way they desire for the entire study period.

Behavioral: Happify

Active control

PLACEBO COMPARATOR

Participants complete a Happify program that is designed to engage with specific activities, but that does not aim to promote positive emotion or reduce negative emotion. Participants gain access to 8 weeks worth of content, but may repeat the content as often as they like in the follow-up period.

Behavioral: Happify

Distraction condition

SHAM COMPARATOR

Participants complete a series of quizzes and polls on Happify designed to engage them in thinking about well-being topics, but without giving any specific instructions for how to promote well-being. Participants gain access to 8 weeks worth of content, but may repeat the content as often as they like in the follow-up period.

Behavioral: Happify

Interventions

HappifyBEHAVIORAL

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

Active controlDistraction conditionUnchanged Happify

Eligibility Criteria

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

You may qualify if:

  • No prior experience on the Happify platform (new user registration)
  • Full-time employment

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Happify (an online platform -- study is entirely online)

New York, New York, 10012, United States

Location

Related 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.

    PMID: 27580524BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 11, 2017

Study Start

October 24, 2017

Primary Completion

March 14, 2018

Study Completion

March 14, 2018

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations