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An Online Trial of Five Well-being Programs

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ClinicalTrials.gov Identifier: NCT03233022
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Happify Inc.

Brief Summary:
Participants complete an 8-week program and complete assessment measures to track their outcomes over time.

Condition or disease Intervention/treatment Phase
Well-being Behavioral: Happify Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: A Randomized Trial Examining the Impact of Five 8-week Online Well-being Programs on Mood and Well-being
Actual Study Start Date : February 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Arm Intervention/treatment
Active Comparator: Unchanged Happify
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
An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.

Active Comparator: Negatively-focused tracks
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.
Behavioral: Happify
An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.

Active Comparator: Positively-focused tracks
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.
Behavioral: Happify
An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.

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

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Resilience composite [ Time Frame: Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up ]
    Composite score made of perceived stress, positive emotionality, and optimism



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233022


Locations
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United States, New York
Happify (an online platform -- study is entirely online)
New York, New York, United States, 10012
Sponsors and Collaborators
Happify Inc.
Additional Information:
Publications:
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Responsible Party: Happify Inc.
ClinicalTrials.gov Identifier: NCT03233022    
Other Study ID Numbers: 1
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided