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/NCT05998161</url>
    </required_header>
    <id_info>
      <org_study_id>reviga RCT 2023</org_study_id>
      <nct_id>NCT05998161</nct_id>
    </id_info>
    <brief_title>Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout</brief_title>
    <official_title>Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout - a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gaia AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Universitätsklinikum Schleswig-Holstein, Campus Kiel</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hannover Medical School</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Gaia AG</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>
        In this single-blinded randomized controlled clinical trial 290 patients with stress or&#xD;
        burnout will be investigated regarding the effectiveness of a digital therapeutic for&#xD;
        improvement of stress level, the unguided online intervention reviga.&#xD;
  &#xD;
        Inclusion criteria are: age 18 or older, above average stress level (PSS score &gt;21), living&#xD;
        in Germany, working a minimum of 20h per week, having a stable treatment for at least 30 days&#xD;
        at the time of inclusion, and consent to participation. Exclusion criterion is having plans&#xD;
        to change the treatment in the upcoming three months at the time of inclusion.&#xD;
  &#xD;
        Patients will be randomized and allocated to either an intervention group, receiving reviga&#xD;
        in addition to treatment as usual (TAU), or a control group, receiving only TAU. The control&#xD;
        group will be granted access to the program at the end of the study. Primary endpoint will be&#xD;
        the perceived stress measured by the PSS score, with three months post-allocation being the&#xD;
        primary time point for assessment of effectiveness. Six months post allocation will be used&#xD;
        as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be anxiety&#xD;
        symptoms, level of functioning, burnout symptoms, health-related quality of life, and sick&#xD;
        days.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 4, 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">May 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>
      <masking_description>All endpoints are patient-reported outcome measures (PROMs). Given that participants are aware of their study group (receiving reviga in addition to treatment as usual or only receiving treatment as usual), this trial is not blinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Stress symptoms</measure>
      <time_frame>3 months</time_frame>
      <description>Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anxiety symptoms</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Generalized Anxiety Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety (worse outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functioning</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Burnout symptoms</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Oldenburg Burnout Inventory (OLBI). Two subscales (exhaustion and disengagement), each ranging from 8-32; higher scores mean higher burnout symptoms (worse outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Assessment of Quality of Life - 8D (AQoL-8D). AQoL-8D score ranging from 0-100; higher scores mean higher quality of life (better outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sick days</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Number of sick days in the past 3 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stress symptoms</measure>
      <time_frame>6 months</time_frame>
      <description>Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Depressive symptoms</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome).</description>
    </other_outcome>
    <other_outcome>
      <measure>Effort and reward imbalance</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Effort-reward-imbalance (ERI). Three subscales: effort, ranging from 3-12, higher scores mean higher effort; reward, ranging from 7=28, higher scores mean higher reward; over-commitment, ranging from 6-24, higher scores mean higher over-commitment. Ratio effort/reward: scores &gt;1 mean more efforts for each reward (worse outcome).</description>
    </other_outcome>
    <other_outcome>
      <measure>hospital stays</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Number of hospital stays in the past 3 months</description>
    </other_outcome>
    <other_outcome>
      <measure>curative stays</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Number of curative stays in the past 3 months</description>
    </other_outcome>
    <other_outcome>
      <measure>doctor visits</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>Number of doctor visits in the past 3 months</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">290</enrollment>
    <condition>Stress</condition>
    <condition>Burnout</condition>
    <arm_group>
      <arm_group_label>reviga + TAU</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants allocated to the intervention group will receive access to reviga in addition to treatment as usual (TAU).&#xD;
  reviga is a digital health application designed for individuals with stress and burnout, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by reviga are relaxation, psychoeducation and exercises regarding relevant cognitions and behavior, acceptance, relationships, problem solving strategies, and positive psychology.&#xD;
  The program operates through interactive &quot;dialogues&quot;, which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TAU</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants allocated to the control group will receive access to treatment as usual (TAU).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>reviga</intervention_name>
      <description>Participants will receive access to the digital health intervention reviga in addition to TAU.</description>
      <arm_group_label>reviga + TAU</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age &gt;= 18&#xD;
  &#xD;
            -  living in Germany&#xD;
  &#xD;
            -  employed (minimum of 20h/week)&#xD;
  &#xD;
            -  increased stress level (&gt;21 on the PSS-10)&#xD;
  &#xD;
            -  stable treatment (psychotherapy, medication, no treatment) for at least 30 days at the&#xD;
               time of inclusion&#xD;
  &#xD;
            -  consent to participation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  plans to change treatment (psychotherapy, medication, ...) in the upcoming three&#xD;
               months at the time of inclusion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kamila Jauch-Chara, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Psychosomatik und Psychotherapie, Zentrum für Integrative Psychiatrie, Michaelistraße 1, 24105 Kiel</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gitta A. Jacob, PhD</last_name>
      <phone>+49.40.349930-374</phone>
      <email>gitta.jacob@gaia-group.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Antje Riepenhausen, M.Sc.</last_name>
      <email>antje.riepenhausen@gaia-group.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>GAIA AG</name>
        <address>
          <city>Hamburg</city>
          <zip>22085</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gitta A. Jacob, PhD</last_name>
        <email>gitta.jacob@gaia-group.com</email>
      </contact>
      <contact_backup>
        <last_name>Antje Riepenhausen, M.Sc.</last_name>
        <email>antje.riepenhausen@gaia-group.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Burnout, Psychological</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/NCT05998161
  org study id: reviga RCT 2023
  nct id: NCT05998161
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this single-blinded randomized controlled clinical trial 290 patients with stress or
        burnout will be investigated regarding the effectiveness of a digital therapeutic for
        improvement of stress level, the unguided online intervention reviga.
  
        Inclusion criteria are: age 18 or older, above average stress level (PSS score >21), living
        in Germany, working a minimum of 20h per week, having a stable treatment for at least 30 days
        at the time of inclusion, and consent to participation. Exclusion criterion is having plans
        to change the treatment in the upcoming three months at the time of inclusion.
  
        Patients will be randomized and allocated to either an intervention group, receiving reviga
        in addition to treatment as usual (TAU), or a control group, receiving only TAU. The control
        group will be granted access to the program at the end of the study. Primary endpoint will be
        the perceived stress measured by the PSS score, with three months post-allocation being the
        primary time point for assessment of effectiveness. Six months post allocation will be used
        as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be anxiety
        symptoms, level of functioning, burnout symptoms, health-related quality of life, and sick
        days.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: All endpoints are patient-reported outcome measures (PROMs). Given that participants are aware of their study group (receiving reviga in addition to treatment as usual or only receiving treatment as usual), this trial is not blinded.
  measure: Stress symptoms
  time frame: 3 months
  description: Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome).
  measure: Anxiety symptoms
  time frame: 3 months, 6 months
  description: Generalized Anxiety Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety (worse outcome).
  measure: Functioning
  time frame: 3 months, 6 months
  description: Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).
  measure: Burnout symptoms
  time frame: 3 months, 6 months
  description: Oldenburg Burnout Inventory (OLBI). Two subscales (exhaustion and disengagement), each ranging from 8-32; higher scores mean higher burnout symptoms (worse outcome).
  measure: Health-related quality of life
  time frame: 3 months, 6 months
  description: Assessment of Quality of Life - 8D (AQoL-8D). AQoL-8D score ranging from 0-100; higher scores mean higher quality of life (better outcome).
  measure: Sick days
  time frame: 3 months, 6 months
  description: Number of sick days in the past 3 months
  measure: Stress symptoms
  time frame: 6 months
  description: Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome).
  measure: Depressive symptoms
  time frame: 3 months, 6 months
  description: Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome).
  measure: Effort and reward imbalance
  time frame: 3 months, 6 months
  description: Effort-reward-imbalance (ERI). Three subscales: effort, ranging from 3-12, higher scores mean higher effort; reward, ranging from 7=28, higher scores mean higher reward; over-commitment, ranging from 6-24, higher scores mean higher over-commitment. Ratio effort/reward: scores >1 mean more efforts for each reward (worse outcome).
  measure: hospital stays
  time frame: 3 months, 6 months
  description: Number of hospital stays in the past 3 months
  measure: curative stays
  time frame: 3 months, 6 months
  description: Number of curative stays in the past 3 months
  measure: doctor visits
  time frame: 3 months, 6 months
  description: Number of doctor visits in the past 3 months
  arm group label: reviga + TAU
  arm group type: Experimental
  description: Participants allocated to the intervention group will receive access to reviga in addition to treatment as usual (TAU).
  reviga is a digital health application designed for individuals with stress and burnout, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by reviga are relaxation, psychoeducation and exercises regarding relevant cognitions and behavior, acceptance, relationships, problem solving strategies, and positive psychology.
  The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.
  arm group label: TAU
  arm group type: No Intervention
  description: Participants allocated to the control group will receive access to treatment as usual (TAU).
  intervention type: Behavioral
  intervention name: reviga
  description: Participants will receive access to the digital health intervention reviga in addition to TAU.
  arm group label: reviga + TAU
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kamila Jauch-Chara, MD
  role: Principal Investigator
  affiliation: Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Psychosomatik und Psychotherapie, Zentrum für Integrative Psychiatrie, Michaelistraße 1, 24105 Kiel
  last name: Gitta A. Jacob, PhD
  phone: +49.40.349930-374
  email: gitta.jacob@gaia-group.com
  last name: Antje Riepenhausen, M.Sc.
  email: antje.riepenhausen@gaia-group.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Burnout, Psychological
  sharing ipd: No