Well-beingNCT03233022
An Online Trial of Five Well-being Programs
A study testing Happify in people with Well-being, run by Happify Inc. at 1 site in United States.
Trial summary
Participants complete an 8-week program and complete assessment measures to track their outcomes over time. 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
- 14,000 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 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)
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 Five 8-week Online Well-being Programs on Mood and Well-being
Participants complete an 8-week program and complete assessment measures to track their outcomes over time.
Read the detailed description
Participants will be randomly assigned between five different well-being programs, each 8-weeks long and taking place on a simplified research version of the Happify platform. They will be asked to complete questionnaires before and after the 8-week program, as well as 1-month, 3-month, and 6-month follow-up questionnaires 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 |
| Negatively-focused tracks | Active comparator | Participants use two pre-selected Happify tracks that focus on remediating negatives (e.g. "conquering negative thoughts" and "managing stress"). Several engagement elements are missing, including social forums, regular informational emails, and the ability to play games. 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 |
| Positively-focused tracks | Active comparator | Participants use two pre-selected Happify tracks that focus on improving positives (e.g. building well-being, using one's strengths). Several engagement elements are missing, including social forums, regular informational emails, and the ability to play games. 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 |
| Placebo condition | 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.
Depressive Symptoms (Patient Health Questionnaire 9-item; PHQ-9)
9-item measure of depressive symptoms
Measured: Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up
Anxiety Symptoms (Generalized Anxiety Disorder 7-item; GAD-7)
7-item measure of anxiety symptoms
Measured: Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up
Secondary outcomes (1)
Resilience composite
Composite score made of perceived stress, positive emotionality, and optimism
Measured: Change from baseline to 8-week post, 1-month, 3-month, and 6-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 posted28 Jul 2017
- Study startFeb 2016
- Primary completionMar 2018
- Study completionMar 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
- 14,000 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
- NCT03233022
- Sponsor's protocol ID
- 1
- Status last verified
- Aug 2017
- First submitted
- 24 Jul 2017
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- 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 Five 8-week Online Well-being Programs on Mood and Well-being
- ClinicalTrials.gov ID
- NCT03233022
- Acronym / sponsor ID
- 1
- Conditions
- Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,000 participants (actual)
- Lead sponsor
- Happify Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 28 Jul 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 complete an 8-week program and complete assessment measures to track their outcomes over time.
Detailed description
Participants will be randomly assigned between five different well-being programs, each 8-weeks long and taking place on a simplified research version of the Happify platform. They will be asked to complete questionnaires before and after the 8-week program, as well as 1-month, 3-month, and 6-month follow-up questionnaires 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
- 5
- 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. |
| Negatively-focused tracks | Active comparator | Behavioral: HappifyParticipants use two pre-selected Happify tracks that focus on remediating negatives (e.g. "conquering negative thoughts" and "managing stress"). Several engagement elements are missing, including social forums, regular informational emails, and the ability to play games. Participants gain access to 8 weeks worth of content, but may repeat the content as often as they like in the follow-up period. |
| Positively-focused tracks | Active comparator | Behavioral: HappifyParticipants use two pre-selected Happify tracks that focus on improving positives (e.g. building well-being, using one's strengths). Several engagement elements are missing, including social forums, regular informational emails, and the ability to play games. Participants gain access to 8 weeks worth of content, but may repeat the content as often as they like in the follow-up period. |
| Placebo condition | 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 (1 listed)
- No prior experience on the Happify platform (new user registration)
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 | Distraction condition, Negatively-focused tracks, Placebo condition, Positively-focused tracks, Unchanged Happify |
Primary outcome
Depressive Symptoms (Patient Health Questionnaire 9-item; PHQ-9)
Time frame: Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up
9-item measure of depressive symptoms
Anxiety Symptoms (Generalized Anxiety Disorder 7-item; GAD-7)
Time frame: Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up
7-item measure of anxiety symptoms
1 secondary outcome
Resilience composite
Time frame: Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up
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 place.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Well-being
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
Recruiting
Demographic Data Collection in Healthcare
Implementation Strategies
Not yet recruiting
ACUTE EFFECTS OF HIGH-INTENSITY LASER THERAPY ON PAIN, MUSCLE STIFFNESS, AND GRIP STRENGTH IN HEALTHY ADULTS
Exercise-Induced Muscle Fatigue, Fatigue Recovery
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 1 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?
Depressive Symptoms (Patient Health Questionnaire 9-item; PHQ-9) (time frame: Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up). The study lists 2 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 NCT03233022, 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.