<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/NCT04432129</url>
  </required_header>
  <id_info>
    <org_study_id>Version 3.1. 27.5.2020</org_study_id>
    <nct_id>NCT04432129</nct_id>
  </id_info>
  <brief_title>Integrated Mental Health Care and Vocational Rehabilitation to People With to Common Mental Disorders</brief_title>
  <acronym>IBBIS II</acronym>
  <official_title>Integrated Mental Health Care and Vocational Rehabilitation Intervention to Individuals on Sick Leave Due to Anxiety, Depression, Personality Disorders, Stress and Functional Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mental Health Centre Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Danish Agency for Labour Market and Recruitment</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central Denmark Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aarhus Kommune</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Københavns Kommune</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mental Health Centre Copenhagen</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 study is to investigate the efficacy of an integrated mental health care&#xD;
      and vocational rehabilitation intervention for people on sick leave because of depression,&#xD;
      stress, anxiety, personality- and functional disorders in Denmark&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Mental illness has an estimated financial burden on the Danish economy of 3.4 % of Gross&#xD;
      National Product every year due to lost productivity, social benefits and healthcare costs&#xD;
      and approximately 50 % of people receiving long-term sickness benefits have a common mental&#xD;
      illness. Furthermore, a significant treatment gap exists where less than 30% were treated for&#xD;
      their mental illness.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      The primary objective of the randomized trial is to examine whether people on sick leave with&#xD;
      a diagnosis of anxiety, depression, stress, personality disorders or functional disorders,&#xD;
      return to work faster and have a higher job retention if they receive an integrated and&#xD;
      optimized vocational rehabilitation and mental health care intervention, compared to people&#xD;
      who receive the standard mental health care and vocational rehabilitation service.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      The trial is designed as an randomized, two-group parallel, assessor-blinded, multisite&#xD;
      trial. A total of 800 participants with a common mental illness will randomly be assigned&#xD;
      into two groups 1) IBBIS II, consisting of an integrated mental health care and vocational&#xD;
      rehabilitation; or 2) Service as usual, at two sites in Denmark. The primary outcome is&#xD;
      difference between the two groups in time to return to work at 12 months.&#xD;
&#xD;
      Results/discussion:&#xD;
&#xD;
      This study will contribute with new knowledge on vocational recovery and integrated&#xD;
      vocational and health care interventions in a Scandinavian context.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 9, 2020</start_date>
  <completion_date type="Actual">October 1, 2022</completion_date>
  <primary_completion_date type="Actual">October 1, 2022</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>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Return to work</measure>
    <time_frame>12 months</time_frame>
    <description>Difference between the two groups in time to return to work from baseline until 12 months after baseline measured whit register based data. Time to return to work is defined as a minimum of four weeks of continuous work without receiving sickness benefit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Work at one point during follow-up</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion in unsupported competitive work at 6 and 12-months follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work</measure>
    <time_frame>6 months</time_frame>
    <description>Time to return to work from baseline until 6 months after baseline measured whit register based data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supported work at one point during follow-up</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion in supported work at 6 and 12-months follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weeks of work</measure>
    <time_frame>12 months</time_frame>
    <description>Number of weeks in competitive employment from baseline to 6 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to new sick leave</measure>
    <time_frame>12 months</time_frame>
    <description>The duration from return to work to potential new sick leave of more than 4 weeks within the 12-month follow-up period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Income</measure>
    <time_frame>12 months</time_frame>
    <description>Salary income from competitive employment at 6 and 12 months after baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of psychiatric services</measure>
    <time_frame>12 months</time_frame>
    <description>Number of admissions, inpatient days and outpatient contacts at the psychiatric hospitals at 6- and 12-months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of somatic services</measure>
    <time_frame>12 months</time_frame>
    <description>Number of admissions, inpatient days and outpatient contacts at the somatic hospitals at 6- and 12-months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of private health care</measure>
    <time_frame>12 months</time_frame>
    <description>Number of contacts with private health care professionals under the Health Insurance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">900</enrollment>
  <condition>Common Mental Disorders</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Personality Disorders</condition>
  <condition>Functional Disease Present</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>IBBIS II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Integrated Mental Health Care and Vocational Rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Service As Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard vocational rehabilitation and treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>IBBIS II</intervention_name>
    <description>The IBBIS-II service consists of:&#xD;
Mental health assessment.&#xD;
Planned integrated service. The participant has the same employment specialists and care manager throughout the intervention. A joint plan is made with shared decisions between the participant, the employment specialist and the care manager. There is a focus on disclosure (openness about illness) and involvement of relatives and significant others.&#xD;
Vocational rehabilitation. Focus on return to work with ongoing assessment of job goals, competencies and need of support. Participants receive help in contacting existing employers (employed) and potential employers (unemployed). Unemployed participants are offered an individualized job search effort. The focus is on competitive jobs within the community.&#xD;
Treatment consists of stepped care with structured treatment guidelines.&#xD;
When the participant has obtained work the team continues to offer support.</description>
    <arm_group_label>IBBIS II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Service as Usual</intervention_name>
    <description>Service as usual consists of standard mental health care and vocational rehabilitation</description>
    <arm_group_label>Service As Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Inclusion criteria&#xD;
&#xD;
          -  Anxiety, depression, stress, personality disorder or functional disorder diagnosed at&#xD;
             a structured diagnostic interview based on the Mini International Neuropsychiatric&#xD;
             Interview conducted by the IBBIS team&#xD;
&#xD;
          -  Sickness benefit recipient at baseline; on sick leave from job or unemployed for a&#xD;
             minimum of four weeks&#xD;
&#xD;
          -  Resident in Copenhagen or Aarhus municipalities&#xD;
&#xD;
          -  Speak sufficient Danish to participate in interviews and complete questionnaires&#xD;
             without an interpreter&#xD;
&#xD;
          -  Aged 18 or older&#xD;
&#xD;
          -  Has given informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  High degree of suicidal ideation&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Abuse of alcohol or other drugs to the degree that participation in therapy is not&#xD;
             possible&#xD;
&#xD;
          -  A need for mental health treatment in secondary sector care&#xD;
&#xD;
          -  Unstable somatic condition that is too severe for participation in the project&#xD;
&#xD;
          -  The participant will not refrain from participating in other psychotherapeutic&#xD;
             treatment outside the IBBIS project if the participant will be allocated to the&#xD;
             experimental group&#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>
  <overall_official>
    <last_name>Lene f Eplov, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mental Health Center Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Copenhagen Research Center for Mental Health - CORE</name>
      <address>
        <city>Copenhagen</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06718-7</url>
    <description>study protocol article</description>
  </link>
  <reference>
    <citation>Christensen TN, Poulsen CH, Ebersbach BK, Eplov LF. Integrated mental health care and vocational rehabilitation intervention to improve return to work rates for people on sick leave due to common mental and functional disorders (IBBIS-II)-a study protocol for a randomized clinical trial. Trials. 2022 Sep 30;23(1):820. doi: 10.1186/s13063-022-06718-7.</citation>
    <PMID>36175977</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>October 5, 2022</last_update_submitted>
  <last_update_submitted_qc>October 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vocational rehabilitation</keyword>
  <keyword>Mental health services</keyword>
  <keyword>Return to Work</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Personality Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be publicly available due to legal restrictions from the Danish data protection agency and the European data protection regulation</ipd_description>
  </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/NCT04432129
org study id: Version 3.1. 27.5.2020
nct id: NCT04432129
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the efficacy of an integrated mental health care
      and vocational rehabilitation intervention for people on sick leave because of depression,
      stress, anxiety, personality- and functional disorders in Denmark
Background:

      Mental illness has an estimated financial burden on the Danish economy of 3.4 % of Gross
      National Product every year due to lost productivity, social benefits and healthcare costs
      and approximately 50 % of people receiving long-term sickness benefits have a common mental
      illness. Furthermore, a significant treatment gap exists where less than 30% were treated for
      their mental illness.

      Objective:

      The primary objective of the randomized trial is to examine whether people on sick leave with
      a diagnosis of anxiety, depression, stress, personality disorders or functional disorders,
      return to work faster and have a higher job retention if they receive an integrated and
      optimized vocational rehabilitation and mental health care intervention, compared to people
      who receive the standard mental health care and vocational rehabilitation service.

      Method:

      The trial is designed as an randomized, two-group parallel, assessor-blinded, multisite
      trial. A total of 800 participants with a common mental illness will randomly be assigned
      into two groups 1) IBBIS II, consisting of an integrated mental health care and vocational
      rehabilitation; or 2) Service as usual, at two sites in Denmark. The primary outcome is
      difference between the two groups in time to return to work at 12 months.

      Results/discussion:

      This study will contribute with new knowledge on vocational recovery and integrated
      vocational and health care interventions in a Scandinavian context.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Return to work
time frame: 12 months
description: Difference between the two groups in time to return to work from baseline until 12 months after baseline measured whit register based data. Time to return to work is defined as a minimum of four weeks of continuous work without receiving sickness benefit.
measure: Work at one point during follow-up
time frame: 12 months
description: Proportion in unsupported competitive work at 6 and 12-months follow up
measure: Return to work
time frame: 6 months
description: Time to return to work from baseline until 6 months after baseline measured whit register based data
measure: Supported work at one point during follow-up
time frame: 12 months
description: Proportion in supported work at 6 and 12-months follow up
measure: Weeks of work
time frame: 12 months
description: Number of weeks in competitive employment from baseline to 6 and 12 months
measure: Time to new sick leave
time frame: 12 months
description: The duration from return to work to potential new sick leave of more than 4 weeks within the 12-month follow-up period
measure: Income
time frame: 12 months
description: Salary income from competitive employment at 6 and 12 months after baseline
measure: Use of psychiatric services
time frame: 12 months
description: Number of admissions, inpatient days and outpatient contacts at the psychiatric hospitals at 6- and 12-months follow-up
measure: Use of somatic services
time frame: 12 months
description: Number of admissions, inpatient days and outpatient contacts at the somatic hospitals at 6- and 12-months follow-up
measure: Use of private health care
time frame: 12 months
description: Number of contacts with private health care professionals under the Health Insurance
arm group label: IBBIS II
arm group type: Experimental
description: Integrated Mental Health Care and Vocational Rehabilitation
arm group label: Service As Usual
arm group type: Active Comparator
description: Standard vocational rehabilitation and treatment
intervention type: Behavioral
intervention name: IBBIS II
description: The IBBIS-II service consists of:
Mental health assessment.
Planned integrated service. The participant has the same employment specialists and care manager throughout the intervention. A joint plan is made with shared decisions between the participant, the employment specialist and the care manager. There is a focus on disclosure (openness about illness) and involvement of relatives and significant others.
Vocational rehabilitation. Focus on return to work with ongoing assessment of job goals, competencies and need of support. Participants receive help in contacting existing employers (employed) and potential employers (unemployed). Unemployed participants are offered an individualized job search effort. The focus is on competitive jobs within the community.
Treatment consists of stepped care with structured treatment guidelines.
When the participant has obtained work the team continues to offer support.
arm group label: IBBIS II
intervention type: Behavioral
intervention name: Service as Usual
description: Service as usual consists of standard mental health care and vocational rehabilitation
arm group label: Service As Usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lene f Eplov, PhD
role: Principal Investigator
affiliation: Mental Health Center Copenhagen
facility: 
country: Denmark
url: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06718-7
description: study protocol article
citation: Christensen TN, Poulsen CH, Ebersbach BK, Eplov LF. Integrated mental health care and vocational rehabilitation intervention to improve return to work rates for people on sick leave due to common mental and functional disorders (IBBIS-II)-a study protocol for a randomized clinical trial. Trials. 2022 Sep 30;23(1):820. doi: 10.1186/s13063-022-06718-7.
PMID: 36175977
responsible party type: Sponsor
mesh term: Depression
mesh term: Personality Disorders
mesh term: Mental Disorders
mesh term: Psychotic Disorders
sharing ipd: No
ipd description: Individual participant data will not be publicly available due to legal restrictions from the Danish data protection agency and the European data protection regulation