Well-beingNCT03306654
Efficacy of Three Online Well-Being Programs to Improve Work-Related Outcomes
A study testing Happify in people with Well-being, run by Happify Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-being
- What is being tested?
- Happify
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,000 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2017to 14 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No prior experience on the Happify platform (new user registration)
- Full-time employment
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Happify (an online platform -- study is entirely online)
New York, New York, 10012
About this study
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
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.
Read the detailed 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.
- Conditions
- Well-being
- Being tested
- Happify
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HappifyBehavioural
An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Happify |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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].
Measured: Change from baseline to 8-week post, 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start24 Oct 2017
- Primary completion14 Mar 2018
- Study completion14 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Well-beingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Happify Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306654
- Sponsor's protocol ID
- 2.5
- Status last verified
- Jul 2018
- First submitted
- 2 Oct 2017
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27580524
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03306654
- Acronym / sponsor ID
- 2.5
- Conditions
- Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Happify Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Unchanged Happify | Active comparator | Behavioral: HappifyParticipants 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. |
| Active control | Placebo comparator | Behavioral: HappifyParticipants 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. |
| Distraction condition | Sham comparator | Behavioral: HappifyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- No prior experience on the Happify platform (new user registration)
- Full-time employment
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HappifyAn online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction. | Behavioural | Active control, Distraction condition, Unchanged Happify |
Primary outcome
Absenteeism (Health and Performance Questionnaire, HPQ [World Health Organization (WHO), 2002])
Time frame: Change from baseline to 8-week post, 1-month follow-up
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).
Work Engagement (Utrecht Work Engagement Scale [Schaufeli et al., 2002])
Time frame: Change from baseline to 8-week post, 1-month follow-up
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.
Burnout (Maslach Burnout Inventory [Maslach & Jackson, 1981])
Time frame: Change from baseline to 8-week post, 1-month follow-up
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).
Job-Related Stress (Stress-related Presenteeism Scale [Gilbreath & Frew, 2008])
Time frame: Change from baseline to 8-week post, 1-month follow-up
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).
Resilience (composite of Perceived Stress Scale [Cohen et al., 1983], Happify Scale [Carpenter et al., 2016] and Life Orientation Scale, Revised [Scheier & Carver, 1985]).
Time frame: Change from baseline to 8-week post, 1-month follow-up
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.
Absenteeism (Healthy Days measure [Center for Disease Control (CDC), 2000])
Time frame: Change from baseline to 8-week post, 1-month follow-up
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].
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Background: PubMed 27580524Carpenter 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.
- Site where study is taking placeLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Happify in people with Well-being, run by Happify Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absenteeism (Health and Performance Questionnaire, HPQ [World Health Organization (WHO), 2002]) (time frame: Change from baseline to 8-week post, 1-month follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03306654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.