<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/NCT03022760</url>
  </required_header>
  <id_info>
    <org_study_id>ISM 03-2015</org_study_id>
    <nct_id>NCT03022760</nct_id>
  </id_info>
  <brief_title>Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care</brief_title>
  <acronym>PRIMA</acronym>
  <official_title>Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care (PRIMA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vastra Gotaland Region</source>
  <brief_summary>
    <textblock>
      The aim of this project is to develop a model for return to work (RTW) for patients sick&#xD;
      listed due to stress related mental disorders, which takes into account each patient's&#xD;
      specific situation; includes the workplace, and is well adapted to the Swedish primary care&#xD;
      setting.&#xD;
&#xD;
      In late 2016, general practitioners (GPs) and rehabilitation coordinators at both public and&#xD;
      private primary care centers will be offered a one-day training about work and workability&#xD;
      for patients with stress related mental disorders. Also, the participants will be trained in&#xD;
      a specific method that includes the patient's employer early in the rehabilitation process&#xD;
&#xD;
      The project has a quasi-experimental and longitudinal design. The intervention will be&#xD;
      conducted on 15 different primary care centers, which will be matched with a comparison&#xD;
      group. Return to work for 500 patients will be analyzed using registry data, 6, 12 and 18&#xD;
      months after sick-listing. The hypothesis is that patients who are sick-listed at primary&#xD;
      care centers that completely or partially implemented the specific method on average will&#xD;
      return earlier to work than patients sick-listed at primary care centers that did not&#xD;
      implement the method.&#xD;
&#xD;
      Alongside studying if the intervention has an effect on the patients' RTW over time, the&#xD;
      investigators aim to investigate the mechanisms explaining the effects and the individual and&#xD;
      organizational level (primary care units) circumstances necessary for these mechanisms to be&#xD;
      triggered. To gain deeper knowledge about mechanisms and context, the investigators will&#xD;
      conduct interviews with the treatment staff and collect registry data about the primary care&#xD;
      units.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">May 2020</completion_date>
  <primary_completion_date type="Actual">January 2019</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>Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.</measure>
    <time_frame>Three measurement time points. First measurement will occur 6 months from baseline.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.</measure>
    <time_frame>Second measurement time point will occur at 12 months from baseline.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.</measure>
    <time_frame>Third measurement time point will occur at 18 months from baseline.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Stress, Psychological</condition>
  <condition>Burnout, Professional</condition>
  <condition>Adjustment Disorders</condition>
  <arm_group>
    <arm_group_label>Work-related measures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One-day training for GP:s and rehabilitation coordinators&#xD;
A treatment protocol which includes contact with the patient's employer&#xD;
Clinical support from the Institute of Stress Medicine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Work-related measures</intervention_name>
    <description>After mapping the patient's psychosocial work situation using tools provided at the one-day training, the patient's employer will be contacted and involved in the rehabilitation planning.</description>
    <arm_group_label>Work-related measures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of International Classification of Diseases (ICD)10 F43&#xD;
&#xD;
          -  Has an employment&#xD;
&#xD;
          -  Good command in spoken and written Swedish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must not have been on long term sick-leave (&gt;60 days) during the last&#xD;
             three years, regardless of causative diagnosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Björk</last_name>
    <role>Study Director</role>
    <affiliation>the Institute of Stress Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Gothenburg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 1, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exhaustion Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burnout, Professional</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
    <mesh_term>Adjustment Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT03022760
org study id: ISM 03-2015
nct id: NCT03022760
lead sponsor: 
collaborator: 
The aim of this project is to develop a model for return to work (RTW) for patients sick
      listed due to stress related mental disorders, which takes into account each patient's
      specific situation; includes the workplace, and is well adapted to the Swedish primary care
      setting.

      In late 2016, general practitioners (GPs) and rehabilitation coordinators at both public and
      private primary care centers will be offered a one-day training about work and workability
      for patients with stress related mental disorders. Also, the participants will be trained in
      a specific method that includes the patient's employer early in the rehabilitation process

      The project has a quasi-experimental and longitudinal design. The intervention will be
      conducted on 15 different primary care centers, which will be matched with a comparison
      group. Return to work for 500 patients will be analyzed using registry data, 6, 12 and 18
      months after sick-listing. The hypothesis is that patients who are sick-listed at primary
      care centers that completely or partially implemented the specific method on average will
      return earlier to work than patients sick-listed at primary care centers that did not
      implement the method.

      Alongside studying if the intervention has an effect on the patients' RTW over time, the
      investigators aim to investigate the mechanisms explaining the effects and the individual and
      organizational level (primary care units) circumstances necessary for these mechanisms to be
      triggered. To gain deeper knowledge about mechanisms and context, the investigators will
      conduct interviews with the treatment staff and collect registry data about the primary care
      units.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.
time frame: Three measurement time points. First measurement will occur 6 months from baseline.
measure: Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.
time frame: Second measurement time point will occur at 12 months from baseline.
measure: Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.
time frame: Third measurement time point will occur at 18 months from baseline.
arm group label: Work-related measures
arm group type: Active Comparator
description: One-day training for GP:s and rehabilitation coordinators
A treatment protocol which includes contact with the patient's employer
Clinical support from the Institute of Stress Medicine
arm group label: Treatment as usual
arm group type: No Intervention
intervention type: Behavioral
intervention name: Work-related measures
description: After mapping the patient's psychosocial work situation using tools provided at the one-day training, the patient's employer will be contacted and involved in the rehabilitation planning.
arm group label: Work-related measures
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Lisa Björk
role: Study Director
affiliation: the Institute of Stress Medicine
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Burnout, Professional
mesh term: Mental Disorders
mesh term: Psychotic Disorders
mesh term: Stress, Psychological
mesh term: Adjustment Disorders