<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/NCT03306654</url>
  </required_header>
  <id_info>
    <org_study_id>2.5</org_study_id>
    <nct_id>NCT03306654</nct_id>
  </id_info>
  <brief_title>Efficacy of Three Online Well-Being Programs to Improve Work-Related Outcomes</brief_title>
  <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</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants will be randomly assigned between three well-being programs, and assessed with&#xD;
      questionnaires before and after the 8-week program, as well as 1-month after the end of the&#xD;
      program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomly assigned between three different well-being programs, with each&#xD;
      program lasting 8-weeks and taking place on a simplified research version of the Happify&#xD;
      platform. Well-being programs include the unchanged Happify platform, a version of the&#xD;
      Happify platform that is designed to engage with specific activities but does not aim to&#xD;
      promote positive emotion or reduce negative emotion (i.e., Placebo condition), and a version&#xD;
      of the Happify platform that encourages thinking about well-being through quizzes and polls&#xD;
      without providing any instructions for promotion (i.e., Wait-list Control). Participants will&#xD;
      be asked to complete questionnaires before and after the 8-week program, as well as a 1-month&#xD;
      follow-up questionnaire after the program is complete, at which point study participation&#xD;
      will end.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Actual">March 14, 2018</completion_date>
  <primary_completion_date type="Actual">March 14, 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>Absenteeism (Health and Performance Questionnaire, HPQ [World Health Organization (WHO), 2002])</measure>
    <time_frame>Change from baseline to 8-week post, 1-month follow-up</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Work Engagement (Utrecht Work Engagement Scale [Schaufeli et al., 2002])</measure>
    <time_frame>Change from baseline to 8-week post, 1-month follow-up</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Burnout (Maslach Burnout Inventory [Maslach &amp; Jackson, 1981])</measure>
    <time_frame>Change from baseline to 8-week post, 1-month follow-up</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Job-Related Stress (Stress-related Presenteeism Scale [Gilbreath &amp; Frew, 2008])</measure>
    <time_frame>Change from baseline to 8-week post, 1-month follow-up</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resilience (composite of Perceived Stress Scale [Cohen et al., 1983], Happify Scale [Carpenter et al., 2016] and Life Orientation Scale, Revised [Scheier &amp; Carver, 1985]).</measure>
    <time_frame>Change from baseline to 8-week post, 1-month follow-up</time_frame>
    <description>Composite score made of perceived stress, positive emotionality, and optimism. Perceived stress was measured using the Perceived Stress Scale (PSS; Cohen, Kamarck, &amp; 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, &amp; 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 &amp; Carver, 1985), a 6-item scale on which participants rate the extent to which they identify with optimistic or pessimistic beliefs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absenteeism (Healthy Days measure [Center for Disease Control (CDC), 2000])</measure>
    <time_frame>Change from baseline to 8-week post, 1-month follow-up</time_frame>
    <description>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].</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">6000</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>Active control</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>Active control</arm_group_label>
    <arm_group_label>Distraction condition</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;
          -  Full-time employment&#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>July 2018</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 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/NCT03306654
org study id: 2.5
nct id: NCT03306654
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
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: Absenteeism (Health and Performance Questionnaire, HPQ [World Health Organization (WHO), 2002])
time frame: Change from baseline to 8-week post, 1-month follow-up
description: 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).
measure: Work Engagement (Utrecht Work Engagement Scale [Schaufeli et al., 2002])
time frame: Change from baseline to 8-week post, 1-month follow-up
description: 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.
measure: Burnout (Maslach Burnout Inventory [Maslach & Jackson, 1981])
time frame: Change from baseline to 8-week post, 1-month follow-up
description: 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).
measure: Job-Related Stress (Stress-related Presenteeism Scale [Gilbreath & Frew, 2008])
time frame: Change from baseline to 8-week post, 1-month follow-up
description: 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).
measure: 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
description: 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.
measure: Absenteeism (Healthy Days measure [Center for Disease Control (CDC), 2000])
time frame: Change from baseline to 8-week post, 1-month follow-up
description: 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].
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: Active control
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: Active control
arm group label: Distraction condition
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