An Online Trial of Five Well-being Programs

July 31, 2018 updated by: Happify Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10012
        • Happify (an online platform -- study is entirely online)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up
7-item measure of anxiety symptoms
Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Happify Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

March 1, 2018

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (ACTUAL)

July 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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