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/NCT05963308</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0SYA-316461</org_study_id>
      <nct_id>NCT05963308</nct_id>
    </id_info>
    <brief_title>Promoting Sustainable Return to Work Among Employees on Sick Leave Due to a Mental Health Condition: Evaluation of the HealthyMinds Online Group Intervention</brief_title>
    <official_title>Promoting Sustainable Return to Work Among Employees on Sick Leave Due to a Mental Health Condition: Evaluation of the HealthyMinds Online Group Intervention</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Université du Québec a Montréal</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ciusss de L'Est de l'Île de Montréal</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>PhysioExtra</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Energir</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Université du Québec a Montréal</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>
        The purpose of this clinical trial is to evaluate the impact of an online group intervention&#xD;
        called Healthy Minds in facilitating a sustainable return to work for individuals with a mood&#xD;
        disorder. The study aims to answer the following key questions :&#xD;
  &#xD;
          -  Does receiving the Healthy Minds online intervention lead to a more sustainable return&#xD;
             to work compared to not receiving the intervention?&#xD;
  &#xD;
          -  Are the health outcomes (e.g., depressive symptoms) and work-related outcomes (e.g.,&#xD;
             work functioning) of individuals who receive the Healthy Minds online intervention&#xD;
             better than those who do not receive the intervention in the year following the&#xD;
             intervention?&#xD;
  &#xD;
        Both experimental and control participants will be recruited at baseline while on sick leave&#xD;
        (expected to return to work in less than one month) or recently returned to work (less than&#xD;
        one month). Participants will complete a series of online questionnaires at the following&#xD;
        time points :&#xD;
  &#xD;
          -  Baseline&#xD;
  &#xD;
          -  First follow-up (2 months after baseline)&#xD;
  &#xD;
          -  Second follow-up (6 months after baseline)&#xD;
  &#xD;
          -  Third follow-up (12 months after baseline)&#xD;
  &#xD;
        The questionnaires will cover the following areas :&#xD;
  &#xD;
          -  Sociodemographic and biopsychosocial factors&#xD;
  &#xD;
          -  Symptoms associated with the primary mood disorder&#xD;
  &#xD;
          -  Cognitive difficulties and biaises&#xD;
  &#xD;
          -  Self-efficacy related to return to work&#xD;
  &#xD;
          -  Work accommodations and natural supports&#xD;
  &#xD;
          -  Relationship with immediate supervisor&#xD;
  &#xD;
          -  Work functioning&#xD;
  &#xD;
          -  Return to work time (number of days away from work)&#xD;
  &#xD;
        Experimental participants will participate in the 2-month online Healthy Minds group&#xD;
        intervention (cohort of 5 participants) between the baseline assessment and the first&#xD;
        follow-up. The intervention consists of 8 sessions (one per week for 8 weeks), with each&#xD;
        session focusing on a specific aspect of the return-to-work process from a&#xD;
        cognitive-behavioral perspective.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 6, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2025</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>Supportive Care</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sustainable return-to-work</measure>
      <time_frame>Baseline + 6 months ; Baseline + 12 months</time_frame>
      <description>The number of days of job retention after returning to work</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depressive symptoms</measure>
      <time_frame>Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months</time_frame>
      <description>Patient Health Questionnaire for depression (PHQ-9; Kroenke et al., 2001)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anxiety symptoms</measure>
      <time_frame>Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months</time_frame>
      <description>Generalized Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Work functioning</measure>
      <time_frame>Baseline + 6 months ; Baseline + 12 months</time_frame>
      <description>Endicott Work Productivity Scale (EWPS; Endicott &amp; Nee, 1997).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Relationship with immediate supervisor</measure>
      <time_frame>Baseline + 6 months ; Baseline + 12 months</time_frame>
      <description>Inventory of perceptions of supervisory style at work (Blais et al., 1991)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Work accommodations</measure>
      <time_frame>Baseline + 6 months ; Baseline + 12 months</time_frame>
      <description>The Work Accommodation and Natural Support Scale (WANSS; Corbière et al., 2014).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Return to Work Obstacles and Self-Efficacy</measure>
      <time_frame>Baseline ; Baseline + 2 months</time_frame>
      <description>Return to Work Obstacles and Self-Efficacy Scale (ROSES ; Corbière et al., 2017 )</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive difficulties</measure>
      <time_frame>Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months</time_frame>
      <description>Online Stroop test (french version, available on https://run.pavlovia.org/FredericBr/stroop_french_v2/html/)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive biases</measure>
      <time_frame>Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months</time_frame>
      <description>Davos Assessment of the Cognitive Biases Scale (Bastiaens et al., 2018; van der Gaag et al., 2013)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Depression ; Anxiety With Depressed Mood ; Mood Disorder, Adjustment Disorder With Depressed Mood</condition>
    <arm_group>
      <arm_group_label>Online group intervention &quot;Healthy Minds&quot;</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Like the intervention group, the control group will complete an online set of questionnaires at the following time points:&#xD;
  Baseline&#xD;
  First follow-up (2 months after baseline)&#xD;
  Second follow-up (6 months after baseline)&#xD;
  Third follow-up (12 months after baseline)&#xD;
  The questionnaires will cover the following domains:&#xD;
  Sociodemographic and biopsychosocial factors&#xD;
  Symptoms associated with the primary mood disorder&#xD;
  Cognitive difficulties and distortions&#xD;
  Self-efficacy in relation to returning to work&#xD;
  Work accommodations and natural supports&#xD;
  Relationship with immediate supervisor&#xD;
  Work functioning&#xD;
  Return-to-work time (number of days away from work)</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Healthy Minds</intervention_name>
      <description>The group intervention (approximately 5 participants per group, 8 groups) is facilitated by two clinicians and consists of 8 sessions (one per week for 8 weeks), with each session focusing on a specific aspect of the return-to-work process from a cognitive-behavioral perspective:&#xD;
  Week1: Coping with work stress at work W2 and W3: Recognizing and modifying my dysfunctional beliefs linked to work W4: Overcoming obstacles linked to work functioning and maintaining work W5: To put in place needed work accommodations with the support of the immediate supervisor W6: My strengths and competencies related to work W7: Accepting criticism and asserting myself appropriately W7: My strengths and related skills W8: My best coping strategies for work Both intervention and control participants receive their standard individualized care from their clinician. However, for the experimental participants, the Healthy Minds intervention is an added component to their regular care.</description>
      <arm_group_label>Online group intervention &quot;Healthy Minds&quot;</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be in the process of returning to work after depression, anxiety disorder, adjustment&#xD;
               disorder (with depressed mood, or anxious mood).&#xD;
  &#xD;
          or&#xD;
  &#xD;
            -  Been back for less than a month&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to communicate in French&#xD;
  &#xD;
            -  Have a known organic disorder&#xD;
  &#xD;
            -  Have already received CBT-type intervention (group or individual)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marc Corbière, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Université du Québec a Montréal</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marc Corbière, PhD</last_name>
      <phone>514-987-3000</phone>
      <phone_ext>5574</phone_ext>
      <email>corbiere.marc@uqam.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Université du Québec à Montréal</name>
        <address>
          <city>Montréal</city>
          <state>Quebec</state>
          <zip>H3C 3P8</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marc Corbière, PhD</last_name>
        <phone>514-987-3000</phone>
        <phone_ext>5574</phone_ext>
        <email>corbiere.marc@uqam.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Université du Québec a Montréal</investigator_affiliation>
      <investigator_full_name>Marc Corbière</investigator_full_name>
      <investigator_title>Full Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Mood Disorders</mesh_term>
      <mesh_term>Adjustment Disorders</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/NCT05963308
  org study id: 2023-0SYA-316461
  nct id: NCT05963308
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this clinical trial is to evaluate the impact of an online group intervention
        called Healthy Minds in facilitating a sustainable return to work for individuals with a mood
        disorder. The study aims to answer the following key questions :
  
          -  Does receiving the Healthy Minds online intervention lead to a more sustainable return
             to work compared to not receiving the intervention?
  
          -  Are the health outcomes (e.g., depressive symptoms) and work-related outcomes (e.g.,
             work functioning) of individuals who receive the Healthy Minds online intervention
             better than those who do not receive the intervention in the year following the
             intervention?
  
        Both experimental and control participants will be recruited at baseline while on sick leave
        (expected to return to work in less than one month) or recently returned to work (less than
        one month). Participants will complete a series of online questionnaires at the following
        time points :
  
          -  Baseline
  
          -  First follow-up (2 months after baseline)
  
          -  Second follow-up (6 months after baseline)
  
          -  Third follow-up (12 months after baseline)
  
        The questionnaires will cover the following areas :
  
          -  Sociodemographic and biopsychosocial factors
  
          -  Symptoms associated with the primary mood disorder
  
          -  Cognitive difficulties and biaises
  
          -  Self-efficacy related to return to work
  
          -  Work accommodations and natural supports
  
          -  Relationship with immediate supervisor
  
          -  Work functioning
  
          -  Return to work time (number of days away from work)
  
        Experimental participants will participate in the 2-month online Healthy Minds group
        intervention (cohort of 5 participants) between the baseline assessment and the first
        follow-up. The intervention consists of 8 sessions (one per week for 8 weeks), with each
        session focusing on a specific aspect of the return-to-work process from a
        cognitive-behavioral perspective.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Investigator, Outcomes Assessor)
  measure: Sustainable return-to-work
  time frame: Baseline + 6 months ; Baseline + 12 months
  description: The number of days of job retention after returning to work
  measure: Depressive symptoms
  time frame: Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months
  description: Patient Health Questionnaire for depression (PHQ-9; Kroenke et al., 2001)
  measure: Anxiety symptoms
  time frame: Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months
  description: Generalized Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)
  measure: Work functioning
  time frame: Baseline + 6 months ; Baseline + 12 months
  description: Endicott Work Productivity Scale (EWPS; Endicott & Nee, 1997).
  measure: Relationship with immediate supervisor
  time frame: Baseline + 6 months ; Baseline + 12 months
  description: Inventory of perceptions of supervisory style at work (Blais et al., 1991)
  measure: Work accommodations
  time frame: Baseline + 6 months ; Baseline + 12 months
  description: The Work Accommodation and Natural Support Scale (WANSS; Corbière et al., 2014).
  measure: Return to Work Obstacles and Self-Efficacy
  time frame: Baseline ; Baseline + 2 months
  description: Return to Work Obstacles and Self-Efficacy Scale (ROSES ; Corbière et al., 2017 )
  measure: Cognitive difficulties
  time frame: Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months
  description: Online Stroop test (french version, available on https://run.pavlovia.org/FredericBr/stroop_french_v2/html/)
  measure: Cognitive biases
  time frame: Baseline ; Baseline + 2 months ; Baseline + 6 months ; Baseline + 12 months
  description: Davos Assessment of the Cognitive Biases Scale (Bastiaens et al., 2018; van der Gaag et al., 2013)
  arm group label: Online group intervention "Healthy Minds"
  arm group type: Experimental
  arm group label: Control group
  arm group type: No Intervention
  description: Like the intervention group, the control group will complete an online set of questionnaires at the following time points:
  Baseline
  First follow-up (2 months after baseline)
  Second follow-up (6 months after baseline)
  Third follow-up (12 months after baseline)
  The questionnaires will cover the following domains:
  Sociodemographic and biopsychosocial factors
  Symptoms associated with the primary mood disorder
  Cognitive difficulties and distortions
  Self-efficacy in relation to returning to work
  Work accommodations and natural supports
  Relationship with immediate supervisor
  Work functioning
  Return-to-work time (number of days away from work)
  intervention type: Behavioral
  intervention name: Healthy Minds
  description: The group intervention (approximately 5 participants per group, 8 groups) is facilitated by two clinicians and consists of 8 sessions (one per week for 8 weeks), with each session focusing on a specific aspect of the return-to-work process from a cognitive-behavioral perspective:
  Week1: Coping with work stress at work W2 and W3: Recognizing and modifying my dysfunctional beliefs linked to work W4: Overcoming obstacles linked to work functioning and maintaining work W5: To put in place needed work accommodations with the support of the immediate supervisor W6: My strengths and competencies related to work W7: Accepting criticism and asserting myself appropriately W7: My strengths and related skills W8: My best coping strategies for work Both intervention and control participants receive their standard individualized care from their clinician. However, for the experimental participants, the Healthy Minds intervention is an added component to their regular care.
  arm group label: Online group intervention "Healthy Minds"
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Marc Corbière, PhD
  role: Principal Investigator
  affiliation: Université du Québec a Montréal
  last name: Marc Corbière, PhD
  phone: 514-987-3000
  phone ext: 5574
  email: corbiere.marc@uqam.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: Université du Québec a Montréal
  investigator full name: Marc Corbière
  investigator title: Full Professor
  mesh term: Depression
  mesh term: Mood Disorders
  mesh term: Adjustment Disorders
  sharing ipd: No