xml: <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/NCT06026280</url>
    </required_header>
    <id_info>
      <org_study_id>R42MH127971</org_study_id>
      <nct_id>NCT06026280</nct_id>
    </id_info>
    <brief_title>Depression Return to Work Intervention</brief_title>
    <acronym>DRIVEN</acronym>
    <official_title>Developing an App-based Behavioral Intervention to Help Depressed Individuals Return to Work</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Inspiration at Work</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Northwestern University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Inspiration at Work</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This study is a randomized controlled trial to test the effectiveness of a mobile app-based&#xD;
        program aimed to help individuals with unemployment-related emotional distress return to&#xD;
        work.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will compare two different approaches to reducing unemployment-related emotional&#xD;
        distress. Participants will be involved in the study for a total of 22 weeks. During the&#xD;
        first 6 weeks, participants will complete activities relating to either the mobile-app based&#xD;
        program or the self-guided job-seeking program. The study team will follow up with&#xD;
        participants at 8 weeks after the program is completed and at 16 weeks after the program is&#xD;
        completed. Participants will also be asked to complete questionnaires before starting the&#xD;
        program, during the program, after they complete the program, and at the follow-up visits.&#xD;
        The questionnaires will be about the participant's mood, job seeking behavior, and related&#xD;
        emotional experiences.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">September 19, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Job Search Behavior (JSB) Scale</measure>
      <time_frame>Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)</time_frame>
      <description>10-item scale to assess the frequency that a person performs certain job seeking behaviors within a week. Each item has 5 answer options (from 0 times to 6 or more times). A higher score indicates that someone performs more job seeking behaviors each week.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Job Search Self Efficacy (JSSE) Scale</measure>
      <time_frame>Baseline; Week 3 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)</time_frame>
      <description>20-item scale to assess someone's confidence in performing job seeking behaviors and achieving job seeking outcomes. Each item has 5 answer options (from 1 to 5). Raw scores of items from each domain are averaged to produce a final domain score between 1 and 5. A higher score indicates that someone is more confident in performing a job seeking behavior or achieving a job seeking outcome, depending on the domain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Inventory of Depression and Anxiety Symptoms (IDAS) - Social Anxiety Subscale</measure>
      <time_frame>Baseline; Week 3 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)</time_frame>
      <description>6-item scale to assess social anxiety symptoms. Each item has 5 answer options (from 1 to 5). A higher score indicates a greater presence of that symptom within the past two weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcome Measures Information System (PROMIS) Depression Scale</measure>
      <time_frame>Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)</time_frame>
      <description>8-item scale to assess depression. Each item has 5 answer options (from 1 to 5). Minimum score = 8; maximum score = 40. A higher score indicates a greater presence of depressive symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcome Measures Information System (PROMIS) Positive Affect Scale</measure>
      <time_frame>Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)</time_frame>
      <description>15-item scale to assess positive affect. Each item has 5 answer options (from 1 to 5). Minimum score = 15; maximum score = 75. A higher score indicates a greater presence of positive affect.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcome Measures Information System (PROMIS) Meaning and Purpose Scale</measure>
      <time_frame>Baseline; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)</time_frame>
      <description>8-item scale to assess meaning and purpose in someone's life. Each item has 5 answer options (from 1 to 5). Minimum score = 8; maximum score = 40. A higher score indicates a greater sense of meaning and purpose.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Behavioral Avoidance Scale (CBAS)</measure>
      <time_frame>Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)</time_frame>
      <description>31-item scale to assess what strategies someone uses to deal with situations and problems, with strategies falling into the domains of behavioral-social, cognitive-nonsocial, cognitive-social, and behavioral-nonsocial. Each item has 5 answer options (from 1 to 5). Raw scores of items from each domain are summed to produce a final domain score. A higher score indicates a greater presence of that coping strategy in someone's life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Behavioral Activation for Depression Scale (BADS)</measure>
      <time_frame>Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)</time_frame>
      <description>9-item scale to assess behavioral activation. Each item has 7 answer options (from 0 to 6). Minimum score = 0; maximum score = 54. A higher score indicates higher activation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Flexibility Inventory (CFI)</measure>
      <time_frame>Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)</time_frame>
      <description>20-item scale to assess cognitive flexibility. Each item has 7 answer options (from 1 to 7). Minimum score = 20; maximum score = 140. A higher score indicates more cognitive flexibility.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant Global Impression of Change (PGIC)</measure>
      <time_frame>Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)</time_frame>
      <description>To assess participant's impression of change in their depression since the start of the intervention. This scale is 1-item. Minimum score = 1; maximum score = 5. A higher score indicates the best change since starting the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>System Usability Scale (SUS)</measure>
      <time_frame>Week 1 of program; Week 6 of program</time_frame>
      <description>10-item measure to assess the usability of the program. Each item has 5 answer options (from 1 to 5). Minimum raw score = 0; maximum raw score = 40. Raw scores are multiplied by 2.5 to give a final score of 0 (representing the worst usability) to 100 (representing the best usability).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Job Status Questionnaire</measure>
      <time_frame>Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)</time_frame>
      <description>Measure to assess whether or not someone obtained a job throughout the course of the study.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Job Stress</condition>
    <condition>Distress, Emotional</condition>
    <arm_group>
      <arm_group_label>Conventional Job-Search Program</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>6 weeks of self-guided job-seeking</description>
    </arm_group>
    <arm_group>
      <arm_group_label>DRIVEN App-Based Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6 weeks of job-seeking guided by the DRIVEN curriculum</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>DRIVEN Application</intervention_name>
      <description>Participants will complete the six-week DRIVEN program, which includes a smartphone application and job coaching.</description>
      <arm_group_label>DRIVEN App-Based Program</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Career Resources</intervention_name>
      <description>Participants will receive weekly information about job-searching skills and resources from a study coordinator for six weeks.</description>
      <arm_group_label>Conventional Job-Search Program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18-65 years of age&#xD;
  &#xD;
            -  Currently unemployed and actively searching for work&#xD;
  &#xD;
            -  Prior to unemployment, were employed full-time (35 hours per week or more) for at&#xD;
               least 1 year&#xD;
  &#xD;
            -  Prior to unemployment, received an individual highest salary of $100,000 or less&#xD;
  &#xD;
            -  Owns an iPhone or Android Phone&#xD;
  &#xD;
            -  Willing and able to provide informed consent&#xD;
  &#xD;
            -  Has a minimum depression score according to the PROMIS depression scale&#xD;
  &#xD;
            -  Able to communicate in English (verbal and written)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Current moderate or severe alcohol/substance use disorders&#xD;
  &#xD;
            -  Current or family history of mania or psychosis&#xD;
  &#xD;
            -  Currently employed, retired, or a full-time student&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alexandra R. Levit</last_name>
      <role>Principal Investigator</role>
      <affiliation>Inspiration at Work</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Stewart A. Shankman, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Northwestern University, Department of Psychiatry and Behavioral Sciences</affiliation>
    </overall_official>
    <overall_official>
      <last_name>James W. Griffith, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Northwestern University, Department of Medical Social Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mystie L. Saturday, BA</last_name>
      <phone>(872) 252-8260</phone>
      <email>mystie.saturday@northwestern.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Inspiration at Work, Inc.</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60614</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alexandra Levit</last_name>
        <phone>773-349-2610</phone>
        <email>arl@alexandralevit.com</email>
      </contact>
      <contact_backup>
        <last_name>Mystie L Saturday</last_name>
        <phone>‪(872) 252-8260‬</phone>
        <email>mystie.saturday@northwestern.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>depression</keyword>
    <keyword>unemployment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Occupational Stress</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026280
  org study id: R42MH127971
  nct id: NCT06026280
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is a randomized controlled trial to test the effectiveness of a mobile app-based
        program aimed to help individuals with unemployment-related emotional distress return to
        work.
  This study will compare two different approaches to reducing unemployment-related emotional
        distress. Participants will be involved in the study for a total of 22 weeks. During the
        first 6 weeks, participants will complete activities relating to either the mobile-app based
        program or the self-guided job-seeking program. The study team will follow up with
        participants at 8 weeks after the program is completed and at 16 weeks after the program is
        completed. Participants will also be asked to complete questionnaires before starting the
        program, during the program, after they complete the program, and at the follow-up visits.
        The questionnaires will be about the participant's mood, job seeking behavior, and related
        emotional experiences.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Job Search Behavior (JSB) Scale
  time frame: Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
  description: 10-item scale to assess the frequency that a person performs certain job seeking behaviors within a week. Each item has 5 answer options (from 0 times to 6 or more times). A higher score indicates that someone performs more job seeking behaviors each week.
  measure: Job Search Self Efficacy (JSSE) Scale
  time frame: Baseline; Week 3 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
  description: 20-item scale to assess someone's confidence in performing job seeking behaviors and achieving job seeking outcomes. Each item has 5 answer options (from 1 to 5). Raw scores of items from each domain are averaged to produce a final domain score between 1 and 5. A higher score indicates that someone is more confident in performing a job seeking behavior or achieving a job seeking outcome, depending on the domain.
  measure: The Inventory of Depression and Anxiety Symptoms (IDAS) - Social Anxiety Subscale
  time frame: Baseline; Week 3 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
  description: 6-item scale to assess social anxiety symptoms. Each item has 5 answer options (from 1 to 5). A higher score indicates a greater presence of that symptom within the past two weeks.
  measure: Patient Reported Outcome Measures Information System (PROMIS) Depression Scale
  time frame: Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
  description: 8-item scale to assess depression. Each item has 5 answer options (from 1 to 5). Minimum score = 8; maximum score = 40. A higher score indicates a greater presence of depressive symptoms.
  measure: Patient Reported Outcome Measures Information System (PROMIS) Positive Affect Scale
  time frame: Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
  description: 15-item scale to assess positive affect. Each item has 5 answer options (from 1 to 5). Minimum score = 15; maximum score = 75. A higher score indicates a greater presence of positive affect.
  measure: Patient Reported Outcome Measures Information System (PROMIS) Meaning and Purpose Scale
  time frame: Baseline; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
  description: 8-item scale to assess meaning and purpose in someone's life. Each item has 5 answer options (from 1 to 5). Minimum score = 8; maximum score = 40. A higher score indicates a greater sense of meaning and purpose.
  measure: Cognitive Behavioral Avoidance Scale (CBAS)
  time frame: Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
  description: 31-item scale to assess what strategies someone uses to deal with situations and problems, with strategies falling into the domains of behavioral-social, cognitive-nonsocial, cognitive-social, and behavioral-nonsocial. Each item has 5 answer options (from 1 to 5). Raw scores of items from each domain are summed to produce a final domain score. A higher score indicates a greater presence of that coping strategy in someone's life.
  measure: Behavioral Activation for Depression Scale (BADS)
  time frame: Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
  description: 9-item scale to assess behavioral activation. Each item has 7 answer options (from 0 to 6). Minimum score = 0; maximum score = 54. A higher score indicates higher activation.
  measure: Cognitive Flexibility Inventory (CFI)
  time frame: Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
  description: 20-item scale to assess cognitive flexibility. Each item has 7 answer options (from 1 to 7). Minimum score = 20; maximum score = 140. A higher score indicates more cognitive flexibility.
  measure: Participant Global Impression of Change (PGIC)
  time frame: Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
  description: To assess participant's impression of change in their depression since the start of the intervention. This scale is 1-item. Minimum score = 1; maximum score = 5. A higher score indicates the best change since starting the intervention.
  measure: System Usability Scale (SUS)
  time frame: Week 1 of program; Week 6 of program
  description: 10-item measure to assess the usability of the program. Each item has 5 answer options (from 1 to 5). Minimum raw score = 0; maximum raw score = 40. Raw scores are multiplied by 2.5 to give a final score of 0 (representing the worst usability) to 100 (representing the best usability).
  measure: Job Status Questionnaire
  time frame: Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
  description: Measure to assess whether or not someone obtained a job throughout the course of the study.
  arm group label: Conventional Job-Search Program
  arm group type: Placebo Comparator
  description: 6 weeks of self-guided job-seeking
  arm group label: DRIVEN App-Based Program
  arm group type: Experimental
  description: 6 weeks of job-seeking guided by the DRIVEN curriculum
  intervention type: Behavioral
  intervention name: DRIVEN Application
  description: Participants will complete the six-week DRIVEN program, which includes a smartphone application and job coaching.
  arm group label: DRIVEN App-Based Program
  intervention type: Other
  intervention name: Career Resources
  description: Participants will receive weekly information about job-searching skills and resources from a study coordinator for six weeks.
  arm group label: Conventional Job-Search Program
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alexandra R. Levit
  role: Principal Investigator
  affiliation: Inspiration at Work
  last name: Stewart A. Shankman, PhD
  role: Principal Investigator
  affiliation: Northwestern University, Department of Psychiatry and Behavioral Sciences
  last name: James W. Griffith, PhD
  role: Principal Investigator
  affiliation: Northwestern University, Department of Medical Social Sciences
  last name: Mystie L. Saturday, BA
  phone: (872) 252-8260
  email: mystie.saturday@northwestern.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Occupational Stress
  sharing ipd: No