<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03233022</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03233022</nct_id>
  </id_info>
  <brief_title>An Online Trial of Five Well-being Programs</brief_title>
  <official_title>A Randomized Trial Examining the Impact of Five 8-week Online Well-being Programs on Mood and Well-being</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Happify Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Happify Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants complete an 8-week program and complete assessment measures to track their&#xD;
      outcomes over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomly assigned between five different well-being programs, each&#xD;
      8-weeks long and taking place on a simplified research version of the Happify platform. They&#xD;
      will be asked to complete questionnaires before and after the 8-week program, as well as&#xD;
      1-month, 3-month, and 6-month follow-up questionnaires after the program is complete, at&#xD;
      which point study participation will end.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive Symptoms (Patient Health Questionnaire 9-item; PHQ-9)</measure>
    <time_frame>Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up</time_frame>
    <description>9-item measure of depressive symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety Symptoms (Generalized Anxiety Disorder 7-item; GAD-7)</measure>
    <time_frame>Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up</time_frame>
    <description>7-item measure of anxiety symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resilience composite</measure>
    <time_frame>Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up</time_frame>
    <description>Composite score made of perceived stress, positive emotionality, and optimism</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">14000</enrollment>
  <condition>Well-being</condition>
  <arm_group>
    <arm_group_label>Unchanged Happify</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negatively-focused tracks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants use two pre-selected Happify tracks that focus on remediating negatives (e.g. &quot;conquering negative thoughts&quot; and &quot;managing stress&quot;). 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Positively-focused tracks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo condition</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Distraction condition</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Happify</intervention_name>
    <description>An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.</description>
    <arm_group_label>Distraction condition</arm_group_label>
    <arm_group_label>Negatively-focused tracks</arm_group_label>
    <arm_group_label>Placebo condition</arm_group_label>
    <arm_group_label>Positively-focused tracks</arm_group_label>
    <arm_group_label>Unchanged Happify</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No prior experience on the Happify platform (new user registration)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Happify (an online platform -- study is entirely online)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.happify.com</url>
    <description>Site where study is taking place.</description>
  </link>
  <reference>
    <citation>Carpenter J, Crutchley P, Zilca RD, Schwartz HA, Smith LK, Cobb AM, Parks AC. Seeing the &quot;Big&quot; 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. Erratum In: J Med Internet Res. 2017 Dec 19;19(12 ):e347.</citation>
    <PMID>27580524</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 31, 2018</last_update_submitted>
  <last_update_submitted_qc>July 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03233022
org study id: 1
nct id: NCT03233022
lead sponsor: 
has dmc: No
Participants complete an 8-week program and complete assessment measures to track their
      outcomes over time.
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.
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.
primary purpose: Other
masking: None (Open Label)
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
description: 9-item measure of depressive symptoms
measure: 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
description: 7-item measure of anxiety symptoms
measure: Resilience composite
time frame: Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up
description: Composite score made of perceived stress, positive emotionality, and optimism
arm group label: Unchanged Happify
arm group type: Active Comparator
description: 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.
arm group label: Negatively-focused tracks
arm group type: Active Comparator
description: 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.
arm group label: Positively-focused tracks
arm group type: Active Comparator
description: 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.
arm group label: Placebo condition
arm group type: Placebo Comparator
description: 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.
arm group label: Distraction condition
arm group type: Sham Comparator
description: 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.
intervention type: Behavioral
intervention name: Happify
description: An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
arm group label: Distraction condition
arm group label: Negatively-focused tracks
arm group label: Placebo condition
arm group label: Positively-focused tracks
arm group label: Unchanged Happify
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
url: http://www.happify.com
description: Site where study is taking place.
citation: 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. Erratum In: J Med Internet Res. 2017 Dec 19;19(12 ):e347.
PMID: 27580524
responsible party type: Sponsor
sharing ipd: Undecided