<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/NCT01721824</url>
  </required_header>
  <id_info>
    <org_study_id>H-2-2011-FSP20</org_study_id>
    <nct_id>NCT01721824</nct_id>
  </id_info>
  <brief_title>The Effect of IPS-MA- A Modified Early Supported Employment Intervention for Individuals With Mood or Anxiety Disorders</brief_title>
  <official_title>IPS-MA - A Randomized Clinical Trial Examining the Effect of a Modified IPS Intervention in Addition to Treatment as Usual Versus Treatment as Usual Alone for Individuals With Mood or Anxiety Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mental Health Centre Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mental Health Centre Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study, is to evaluate the effect of a supported employment&#xD;
      intervention, IPS-modified for people with mood and anxiety (IPS-MA) on employment or&#xD;
      education, when offered to people with onset mood or anxiety disorders who are not likely to&#xD;
      be able to return to work within three month.&#xD;
&#xD;
      The hypothesis is that the IPS-MA method is associated with a shorter recovery period and&#xD;
      more people returning to work or education, compared to treatment as usual.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The IPS-MA method is a modified Individual Placement and Support (IPS)&#xD;
      intervention, aiming at supporting people with mood or anxiety disorders regain their&#xD;
      workability and return to work or education. Previous studies have showed, that IPS has an&#xD;
      effect on employment when offered to people with severe mental illness. Further studies are&#xD;
      crucial to demonstrate whether the modified IPS, the IPS-MA method, has an effect when&#xD;
      offered to people with mood or anxiety disorders who are not yet chronified.&#xD;
&#xD;
      Methods/design:The trial design is a randomized, assessor-blinded, clinical trial of the&#xD;
      IPS-MA method in addition to treatment as usual compared to treatment as usual alone for 326&#xD;
      participants diagnosed with a mood or anxiety disorder, living in the Capital Region of&#xD;
      Denmark. The primary outcome is competitive employment or education. Secondary outcomes are&#xD;
      days of competitive employment or education, disease symptoms, level of functioning, and&#xD;
      quality of life at follow-up 12 and 24 months after baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Competitive employment or education</measure>
    <time_frame>24 months</time_frame>
    <description>Competitive employment includes being on rehabilitation benefits, flexible jobs and wage subsidy job. Information on employment and education will be extracted from the DREAM database. This database is administered by The National Labour Market Authority and contains information on employment, sickness leave, educations eligible to state education grant, pre-vocational training, disability pension, social security, and sickness benefits.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of days of competitive employment or studying</measure>
    <time_frame>24 months</time_frame>
    <description>Information will be obtained from the Dream database.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Rating Scale for Depression - 6 items</measure>
    <time_frame>24 months</time_frame>
    <description>Level of symptoms of depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Rating Scale for anxiety -6 item scale</measure>
    <time_frame>24 months</time_frame>
    <description>Level of symptoms of anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of Function (GAF-F)</measure>
    <time_frame>24 months</time_frame>
    <description>Level of function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHO-5 well-being index</measure>
    <time_frame>24 months</time_frame>
    <description>Level of health-related quality of life</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Competitive employment or studying</measure>
    <time_frame>12 months</time_frame>
    <description>Competitive employment includes being on rehabilitation benefits, flexible jobs and wage subsidy jobs. Information on employment and education will be extracted from the DREAM database. The database is administered by The National Labour Market Authority and contains information on employment, sickness leave, educations eligible to state education grant, pre-vocational training, disability pension, social security, and sickness benefits.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changing from matchgroup 2 or 3 to matchgroup 1</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>If participants are matchgroup 2 or 3, they are not able to go back to work within the following 3 months. If participants are matchgroup 1, they should be actively seeking jobs.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of days of competitive employment or studying</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Information will be obtained from the Dream database.</description>
  </other_outcome>
  <other_outcome>
    <measure>Time until returning to employment or education</measure>
    <time_frame>24 months</time_frame>
    <description>Information will be obtained from the Dream database.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hamilton Rating Scale for Depression - 6 items</measure>
    <time_frame>12 months</time_frame>
    <description>Level of symptoms of depression</description>
  </other_outcome>
  <other_outcome>
    <measure>Hamilton Rating Scale for anxiety -6 item scale</measure>
    <time_frame>12 months</time_frame>
    <description>Level of symptoms of anxiety</description>
  </other_outcome>
  <other_outcome>
    <measure>The Bech-Rafaelsen Mania Scale (MAS)</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Level of symptoms af mania</description>
  </other_outcome>
  <other_outcome>
    <measure>Global Assessment of Function (GAF-F)</measure>
    <time_frame>12 months</time_frame>
    <description>Level of function</description>
  </other_outcome>
  <other_outcome>
    <measure>Personal and Social Performance (PSP)</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Social performance in four domains (socailly usefull activities, personal and social relationships, self-care and disturbing and aggressive behaviour)</description>
  </other_outcome>
  <other_outcome>
    <measure>WHO-5 well-being index</measure>
    <time_frame>12 months</time_frame>
    <description>Level of health-related quality of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Sheehan Disability Scale (SDS)</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Level of function regarding social relationships, work, spare time and family.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Empowerment Scale</measure>
    <time_frame>12 and 24 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The Changes Questionnaire</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Motivation to seeking employment or education</description>
  </other_outcome>
  <other_outcome>
    <measure>The Client Satisfaction Questionnaire</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>Satisfaction with treatment</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">326</enrollment>
  <condition>Affective Disorder</condition>
  <condition>Major Depressive Disorder</condition>
  <condition>Bipolar Disorder</condition>
  <condition>Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>IPS-MA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The IPS-MA method consists of five basic services for the participants. 1)Individual mentor support, based on psychiatric knowledge. 2)Coordination by the mentor of activities, internal as well as from external providers. 3)Career counseling aimed at people with mental illnesses. 4)Impartial help to clarify private economy. 5) Contact to employers to help participants obtain jobs, and keep them.&#xD;
Participants will receive the IPS-MA method in addition to treatment as usual.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomised to the control group will receive &quot;treatment as usual&quot; only. This means the standard support offered by the social- and health services in Denmark.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The IPS-MA method</intervention_name>
    <description>During the first 6 months participants are usually offered 3 meetings with their mentor per month, lasting approximately 1 1/2 hours each. The following 6 months they are offered 1 meeting per month, lasting approximately 1 hour. The estimated duration of the IPS-MA intervention is 12 months, but since the needs of the participants are very individual, this may vary.</description>
    <arm_group_label>IPS-MA</arm_group_label>
    <other_name>IPS-modified for people recently diagnosed with mood or anxiety disorders (IPS-MA)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed following the International Classification of Diseases (ICD-10) criteria of&#xD;
             affective disorder (F30-39) or anxiety disorder (F40-41)&#xD;
&#xD;
          -  Not able to work within 3 months&#xD;
&#xD;
          -  Associated with the Mental Health Center Copenhagen, Frederiksberg, Hillerød, Hvidovre&#xD;
             or Ballerup&#xD;
&#xD;
          -  Only having had contact to the Mental Health services during the past 3 years&#xD;
&#xD;
          -  Having had competitive employment or attending a study within the past two years.&#xD;
&#xD;
          -  Has returning to work or education as an important goal&#xD;
&#xD;
          -  Under the age of 60&#xD;
&#xD;
          -  Able to speak, read and understand danish&#xD;
&#xD;
          -  Has given informed consent verbally and in writing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A somatic disease that effects the workability&#xD;
&#xD;
          -  Substance og alcohol abuse&#xD;
&#xD;
          -  have a guardian or a forensic psychiatric arrangement&#xD;
&#xD;
          -  not given informed consent&#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>Lene F Eplov, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mental Health Center Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mental Health Center Ballerup, Mental Health Center Frederiksberg, Mental Health Center Copenhagen, and Mental Health Center of Northern Seeland</name>
      <address>
        <city>Ballerup</city>
        <zip>2750</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Campbell K, Bond GR, Drake RE. Who benefits from supported employment: a meta-analytic study. Schizophr Bull. 2011 Mar;37(2):370-80. doi: 10.1093/schbul/sbp066. Epub 2009 Aug 6.</citation>
    <PMID>19661196</PMID>
  </reference>
  <reference>
    <citation>Bond GR, Drake RE, Becker DR. An update on randomized controlled trials of evidence-based supported employment. Psychiatr Rehabil J. 2008 Spring;31(4):280-90. doi: 10.2975/31.4.2008.280.290.</citation>
    <PMID>18407876</PMID>
  </reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>July 6, 2016</last_update_submitted>
  <last_update_submitted_qc>July 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mental Health Centre Copenhagen</investigator_affiliation>
    <investigator_full_name>Lene Falgaard Eplov</investigator_full_name>
    <investigator_title>Senior consultant, PhD</investigator_title>
  </responsible_party>
  <keyword>Supported employment</keyword>
  <keyword>Individual Placement and Support</keyword>
  <keyword>Workability</keyword>
  <keyword>Return to work</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Mood 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>


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/NCT01721824
org study id: H-2-2011-FSP20
nct id: NCT01721824
lead sponsor: 
has dmc: No
The aim of the present study, is to evaluate the effect of a supported employment
      intervention, IPS-modified for people with mood and anxiety (IPS-MA) on employment or
      education, when offered to people with onset mood or anxiety disorders who are not likely to
      be able to return to work within three month.

      The hypothesis is that the IPS-MA method is associated with a shorter recovery period and
      more people returning to work or education, compared to treatment as usual.
Background: The IPS-MA method is a modified Individual Placement and Support (IPS)
      intervention, aiming at supporting people with mood or anxiety disorders regain their
      workability and return to work or education. Previous studies have showed, that IPS has an
      effect on employment when offered to people with severe mental illness. Further studies are
      crucial to demonstrate whether the modified IPS, the IPS-MA method, has an effect when
      offered to people with mood or anxiety disorders who are not yet chronified.

      Methods/design:The trial design is a randomized, assessor-blinded, clinical trial of the
      IPS-MA method in addition to treatment as usual compared to treatment as usual alone for 326
      participants diagnosed with a mood or anxiety disorder, living in the Capital Region of
      Denmark. The primary outcome is competitive employment or education. Secondary outcomes are
      days of competitive employment or education, disease symptoms, level of functioning, and
      quality of life at follow-up 12 and 24 months after baseline.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Competitive employment or education
time frame: 24 months
description: Competitive employment includes being on rehabilitation benefits, flexible jobs and wage subsidy job. Information on employment and education will be extracted from the DREAM database. This database is administered by The National Labour Market Authority and contains information on employment, sickness leave, educations eligible to state education grant, pre-vocational training, disability pension, social security, and sickness benefits.
measure: Number of days of competitive employment or studying
time frame: 24 months
description: Information will be obtained from the Dream database.
measure: Hamilton Rating Scale for Depression - 6 items
time frame: 24 months
description: Level of symptoms of depression
measure: Hamilton Rating Scale for anxiety -6 item scale
time frame: 24 months
description: Level of symptoms of anxiety
measure: Global Assessment of Function (GAF-F)
time frame: 24 months
description: Level of function
measure: WHO-5 well-being index
time frame: 24 months
description: Level of health-related quality of life
measure: Competitive employment or studying
time frame: 12 months
description: Competitive employment includes being on rehabilitation benefits, flexible jobs and wage subsidy jobs. Information on employment and education will be extracted from the DREAM database. The database is administered by The National Labour Market Authority and contains information on employment, sickness leave, educations eligible to state education grant, pre-vocational training, disability pension, social security, and sickness benefits.
measure: Changing from matchgroup 2 or 3 to matchgroup 1
time frame: 12 and 24 months
description: If participants are matchgroup 2 or 3, they are not able to go back to work within the following 3 months. If participants are matchgroup 1, they should be actively seeking jobs.
measure: Number of days of competitive employment or studying
time frame: 12 and 24 months
description: Information will be obtained from the Dream database.
measure: Time until returning to employment or education
time frame: 24 months
description: Information will be obtained from the Dream database.
measure: Hamilton Rating Scale for Depression - 6 items
time frame: 12 months
description: Level of symptoms of depression
measure: Hamilton Rating Scale for anxiety -6 item scale
time frame: 12 months
description: Level of symptoms of anxiety
measure: The Bech-Rafaelsen Mania Scale (MAS)
time frame: 12 and 24 months
description: Level of symptoms af mania
measure: Global Assessment of Function (GAF-F)
time frame: 12 months
description: Level of function
measure: Personal and Social Performance (PSP)
time frame: 12 and 24 months
description: Social performance in four domains (socailly usefull activities, personal and social relationships, self-care and disturbing and aggressive behaviour)
measure: WHO-5 well-being index
time frame: 12 months
description: Level of health-related quality of life
measure: Sheehan Disability Scale (SDS)
time frame: 12 and 24 months
description: Level of function regarding social relationships, work, spare time and family.
measure: The Empowerment Scale
time frame: 12 and 24 months
measure: The Changes Questionnaire
time frame: 12 and 24 months
description: Motivation to seeking employment or education
measure: The Client Satisfaction Questionnaire
time frame: 12 and 24 months
description: Satisfaction with treatment
arm group label: IPS-MA
arm group type: Experimental
description: The IPS-MA method consists of five basic services for the participants. 1)Individual mentor support, based on psychiatric knowledge. 2)Coordination by the mentor of activities, internal as well as from external providers. 3)Career counseling aimed at people with mental illnesses. 4)Impartial help to clarify private economy. 5) Contact to employers to help participants obtain jobs, and keep them.
Participants will receive the IPS-MA method in addition to treatment as usual.
arm group label: Control group
arm group type: No Intervention
description: Participants randomised to the control group will receive "treatment as usual" only. This means the standard support offered by the social- and health services in Denmark.
intervention type: Behavioral
intervention name: The IPS-MA method
description: During the first 6 months participants are usually offered 3 meetings with their mentor per month, lasting approximately 1 1/2 hours each. The following 6 months they are offered 1 meeting per month, lasting approximately 1 hour. The estimated duration of the IPS-MA intervention is 12 months, but since the needs of the participants are very individual, this may vary.
arm group label: IPS-MA
other name: IPS-modified for people recently diagnosed with mood or anxiety disorders (IPS-MA)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Lene F Eplov, MD, PhD
role: Principal Investigator
affiliation: Mental Health Center Copenhagen
facility: 
country: Denmark
citation: Campbell K, Bond GR, Drake RE. Who benefits from supported employment: a meta-analytic study. Schizophr Bull. 2011 Mar;37(2):370-80. doi: 10.1093/schbul/sbp066. Epub 2009 Aug 6.
PMID: 19661196
citation: Bond GR, Drake RE, Becker DR. An update on randomized controlled trials of evidence-based supported employment. Psychiatr Rehabil J. 2008 Spring;31(4):280-90. doi: 10.2975/31.4.2008.280.290.
PMID: 18407876
responsible party type: Principal Investigator
investigator affiliation: Mental Health Centre Copenhagen
investigator full name: Lene Falgaard Eplov
investigator title: Senior consultant, PhD
mesh term: Anxiety Disorders
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
mesh term: Bipolar Disorder
mesh term: Mood Disorders
sharing ipd: No