<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/NCT03301922</url>
  </required_header>
  <id_info>
    <org_study_id>2015/1794</org_study_id>
    <nct_id>NCT03301922</nct_id>
  </id_info>
  <brief_title>Metacognitive Therapy and Work Interventions for Patients on Sick Leave Due to Common Mental Disorders</brief_title>
  <official_title>Metacognitive Therapy and Work Interventions for Patients on Sick Leave Due to Common Mental Disorders: A Randomized Waiting List Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Diakonhjemmet Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</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>
      Common mental health disorders such as anxiety and depression are leading causes of sickness&#xD;
      absence and disability in Norway. Despite tremendous costs for individual and society,&#xD;
      effective treatment is lacking. Mental health interventions do not typically target work&#xD;
      situation, despite its importance for patient well-being. On a policy level, effective&#xD;
      measures are impeded by a paucity of scientific data, and programs designed to address the&#xD;
      issue such as Faster Return to Work (&quot;Raskere tilbake&quot;) lack evaluation. The present project&#xD;
      will test the effectiveness of Metacognitive therapy and work-focused interventions for&#xD;
      reducing sick leave in patients with common mental disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Common mental health disorders (CMD) such as anxiety and depression are leading contributors&#xD;
      to the global burden of disease , generating substantial costs for societies in reduced&#xD;
      productivity and increased benefit pay outs. In 2010, the worldwide cost of mental health&#xD;
      disability was estimated at US$2.5-8.5 trillion in lost output, and the sum is projected to&#xD;
      double by 2030 unless effective policy measures are implemented. For middle- and high-income&#xD;
      countries, 30-50 % of disability applications stem from mental health issues, and the&#xD;
      proportion is likely greater among the younger part of the work force. In Europe, depression&#xD;
      is responsible for 13.7 % of all years lived with disability, and anxiety disorders likely&#xD;
      have similar impact. Mental health issues are among the leading causes of disability and&#xD;
      early retirement across the European region.&#xD;
&#xD;
      For affected individuals, anxiety and depression reduces quality of life, decreases&#xD;
      functioning and increases the risk of further health problems. Sick leave is often used for&#xD;
      adults with CMD, but may not always be helpful. Avoidance and isolation are behavioural&#xD;
      strategies that maintain anxiety and depression. Absenteeism from work, an important social&#xD;
      arena, may strengthen this behaviour, impeding recovery. Even when controlling for the impact&#xD;
      of ill health, short term sick leave may in itself increase the risk of future long term&#xD;
      absence. In addition, employment rates are 10-15% lower for people with mental ill health&#xD;
      than the rest of the population. Exclusion from the work force is in turn associated with&#xD;
      poorer mental health, and can heighten the risk of futures depression and even suicide. The&#xD;
      relationship between CMD and reduced work-participation is therefore likely bidirectional,&#xD;
      and sick leave may not work as intended despite its high cost for society.&#xD;
&#xD;
      The individual and societal burden from sick leave and mental health represents a key policy&#xD;
      challenge on the global agenda and the need for efficient measures is urgent. Norway&#xD;
      exemplifies this urgent need as expenditure on disability and sickness absence totals 5 % of&#xD;
      GDP, by far the highest in the OECD. Efforts have been made to address the issue through&#xD;
      several policy initiatives, such as the nationwide Faster Return to Work (FRW) program. The&#xD;
      program facilitates buying treatment from different actors to reduce waiting times and thus&#xD;
      potentially the duration of sick leave. The impact of the program is uncertain, as little&#xD;
      research has been done on its efficacy. Scientific data on Norwegian sick leave follow up is&#xD;
      mostly absent. Despite the magnitude of the challenge, there is a clear knowledge gap.&#xD;
&#xD;
      Investment in sick leave follow up has not been equally distributed amongst patient groups.&#xD;
      Sixty per cent of all working days lost to disability or sick leave are due to mental health&#xD;
      issues and musculoskeletal complaints. Sick leave due to CMD is growing. When caused by&#xD;
      mental health issues, disability pension is awarded on average nine years earlier than for&#xD;
      somatic reasons, resulting in more working years lost to disability. Though prevalent in the&#xD;
      statistics, few CMD patients on sick leave receive treatment. Only 1.4 % of employees on sick&#xD;
      leave are referred to specialized mental health treatment. As many as one in three people&#xD;
      awarded disability pension for mental illness have never received any form of treatment prior&#xD;
      to disability being granted. This shows a severe under-referral and under-treatment for this&#xD;
      patient group despite being responsible for the majority of sick leave and disability costs.&#xD;
&#xD;
      A more targeted approach, integrating work-focused interventions with effective CMD treatment&#xD;
      is needed for this patient group. Two recent studies have examined such an approach. In the&#xD;
      Netherlands, Lagerveld and Blonk conducted a randomized controlled trial where 168 patients&#xD;
      on sick leave due to CMD received either cognitive behavioural therapy (CBT), or CBT with an&#xD;
      integrated work-focused intervention. Their results showed a 20 % decrease in sickness&#xD;
      absence for patients receiving the work-focused intervention, while maintaining effective&#xD;
      symptom reduction. In Germany, similar results were found with a smaller sample size. A&#xD;
      multicentre trial in Norway looked at registry data for 1193 CMD patients receiving a&#xD;
      variation of work-specific interventions, showing a clear reduction in sick leave and&#xD;
      disability. Integrated work-focused treatment for CMD is thus a promising avenue of research.&#xD;
&#xD;
      Metacognitive therapy (MCT) is a treatment based on more recent theoretical developments. It&#xD;
      has shown excellent results for anxiety and depression, and the treatment protocol for&#xD;
      generalized anxiety disorder and social phobia is recommended in the NICE guidelines. Rather&#xD;
      than challenging and changing specific thought content (CBT), metacognitive treatment aims to&#xD;
      change and challenge maladaptive cognitive processes, among these rumination and worry, which&#xD;
      are key components in CMD and sick leave.&#xD;
&#xD;
      The study will be a randomized controlled trial. Participants will be persons with a primary&#xD;
      diagnosis of common mental disorders, anxiety and depression. Experienced independent&#xD;
      diagnosticians will assess all patients by using structural interviews MINI (MINI&#xD;
      International Neuropsychiatric Interview).&#xD;
&#xD;
      All patients will be randomized in blocks to two groups in order to compare the following&#xD;
      conditions: MCT and work-focused interventions, and a wait list control condition. After the&#xD;
      waiting period of either 8 or 12 weeks, the patients in the wait-list condition will be&#xD;
      allocated to the treatment condition. Both between-subjects and within-subjects comparisons&#xD;
      will be conducted.&#xD;
&#xD;
      Questions that will be addressed are:&#xD;
&#xD;
        1. MCT and work-focused interventions will be superior to the wait-list condition in make&#xD;
           participants return to work&#xD;
&#xD;
        2. Which changes in predictors related to treatment predict return to work&#xD;
&#xD;
        3. MCT and work-focused interventions will be superior to the wait-list condition for&#xD;
           improving mental health&#xD;
&#xD;
        4. MCT and work-focused interventions will be more cost-efficient than the wait-list&#xD;
           condition&#xD;
&#xD;
        5. Evaluate the sustainability of return to work for patients on sick leave due to common&#xD;
           mental disorders after MCT and work-focused interventions&#xD;
&#xD;
        6. Examine impact of different potential prognostic factors on work function, both at the&#xD;
           end of treatment and at one year follow-up.&#xD;
&#xD;
        7. If the effect of MCT and work-focused interventions will sustain one year after the end&#xD;
           of therapy&#xD;
&#xD;
        8. Explore if patients will have reduced use of sick leave in the four years following&#xD;
           after treatment compared to the two years prior to treatment based on register data.&#xD;
&#xD;
      The meta-cognitive treatment program is based on Wells' manual. The work-focused intervention&#xD;
      is based on an adopted Norwegian version of Lagerveld and Blonk. The interventions are run in&#xD;
      parallel. The patients who are receiving MCT and work-focused interventions will be treated&#xD;
      up to maximum 12 sessions, with weekly session of 45-60 minute duration.&#xD;
&#xD;
      The treatment will be administered according to the originators published treatment protocols&#xD;
      for MCT.&#xD;
&#xD;
        1. All patients referred to the clinic will be consecutively assessed at intake (MINI).&#xD;
           Based on diagnosis and criteria for inclusion and exclusion, the patients will be asked&#xD;
           to volunteer to participate in the study and confirm by signing a form of consent.&#xD;
&#xD;
        2. Patients will be randomized to one of the two conditions.&#xD;
&#xD;
        3. Patients will be asked to self-rate symptoms on a battery of self-report questionnaires.&#xD;
&#xD;
        4. Work-focused meta-cognitive therapy will be given to patients in group 1, while group 2&#xD;
           is a waiting list control. Waiting list controls will be rated but not treated and will&#xD;
           wait for treatment for either 8 or 12 weeks.&#xD;
&#xD;
        5. After waiting they will be transferred to the treatment group.&#xD;
&#xD;
        6. The patients will be assessed prior to treatment, by at end of treatment weeks in&#xD;
           treatment, and at six months and at, one and two years of follow-up.&#xD;
&#xD;
        7. Reassessment of the diagnosis and symptom severity is made by post-treatment.&#xD;
&#xD;
      Criteria for recovery will be: Jacobsen criteria of a minimum change and patients crossing&#xD;
      the cut-off point on two measures: The BDI and BAI. Other outcome measures will include:&#xD;
&#xD;
        -  Reduction of depressive symptoms as measured by self-report questionnaires&#xD;
&#xD;
        -  Number of patients with no diagnosis based on MINI after treatment&#xD;
&#xD;
        -  Relapse rate during six months and at, one year follow-up&#xD;
&#xD;
      A comparison between the two groups of patients will be conducted at post-treatment.&#xD;
      Follow-up data will be analysed based on 6 month and at one year of follow up for the&#xD;
      treatment condition with self-report and a four year follow-up with register data. A within&#xD;
      group analyses will be conducted in order to estimate effect sizes and significant clinical&#xD;
      change estimates.&#xD;
&#xD;
      Participants will be randomized in patients divided on three conditions in a 1:2 ratio. One&#xD;
      factors are controlled for in the randomization, namely, gender. A computer program provided&#xD;
      by NTNU WebCRF will generate the randomization list.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Anticipated">April 2023</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>
    <intervention_model_description>Randomised Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in degree of sick leave</measure>
    <time_frame>From 2 years prior to intervention - to 4 years after intervention</time_frame>
    <description>data from National registers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in degree of sick leave</measure>
    <time_frame>From 2 years prior to intervention - to 4 years after intervention</time_frame>
    <description>data from patients self-report</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in anxiety symptoms</measure>
    <time_frame>From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up</time_frame>
    <description>Changes in depressive symptoms measured by Beck Anxiety Inventory (BAI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in depressive symptoms</measure>
    <time_frame>From pre treatment, to post treatment (12 weeks), 6 months 1 year follow-up</time_frame>
    <description>Changes in depressive symptoms measured by Beck Depression Inventory II (BDI-II)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in metacognitions</measure>
    <time_frame>From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up</time_frame>
    <description>Changes in metacognitions symptoms measured by the Metacognitions Questionnaire 30 (MCQ-30)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in subjective health complaints</measure>
    <time_frame>From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up</time_frame>
    <description>Changes in symptoms measured by Subjective Health Complaints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in bullying and victimisation at work</measure>
    <time_frame>From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up</time_frame>
    <description>Changes in measured Negative Acts Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self-efficacy</measure>
    <time_frame>From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up</time_frame>
    <description>Changes measured with Return to work self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in resilience</measure>
    <time_frame>From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up</time_frame>
    <description>Changes measured with The resilience scale for adults (RSA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life</measure>
    <time_frame>From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up</time_frame>
    <description>Changes measured with EQ-5D-5L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MINI - diagnostic interview</measure>
    <time_frame>From pre treatment, to post treatment (12 weeks)</time_frame>
    <description>Diagnostic evaluations using MINI - International Neuropsychiatric Interview</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Secondary analysis related to the onset of Covid-19</measure>
    <time_frame>From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up</time_frame>
    <description>Sub-analyses taking into consideration the onset of Covid-19 in Norway by mid March 2020</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Work-focused metacognitive therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Work-focused metacognitive therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Waiting list</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Metacognitive therapy and work-focused interventions</intervention_name>
    <description>Metacognitive therapy and work-focused interventions, up to maximum 12 sessions, with weekly session of 45-60 minute duration. The metacognitive treatment program is based on Wells' manual. The work-focused intervention is based on Lagerveld and Blonk. The interventions are run in parallel.</description>
    <arm_group_label>Waiting list</arm_group_label>
    <arm_group_label>Work-focused metacognitive therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Waiting list</intervention_name>
    <description>Waiting list</description>
    <arm_group_label>Waiting list</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  on sick leave either partial or full, due to&#xD;
&#xD;
          -  clinically relevant level of anxiety and depression, and&#xD;
&#xD;
          -  eligible for work-related sick leave pay outs&#xD;
&#xD;
          -  given consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious mental illness (such as bipolar disorder or schizophrenia)&#xD;
&#xD;
          -  Substance abuse&#xD;
&#xD;
          -  Cluster A and B personality disorder&#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>Odin Hjemdal, prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ragne GH Gjengedal</last_name>
    <role>Study Chair</role>
    <affiliation>Diakonhjemmet Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Odin Hjemdal, prof</last_name>
    <phone>0047 73597889</phone>
    <email>odin.hjemdal@ntnu.no</email>
  </overall_contact>
  <location>
    <facility>
      <name>Poliklinikken Raskere Tilbake, Diakonhjemmet Sykehus</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Odin Hjemdal, phd prof</last_name>
      <email>odin.hjemdal@ntnu.no</email>
    </contact>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>September 16, 2022</last_update_submitted>
  <last_update_submitted_qc>September 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Occupational Health Services</keyword>
  <keyword>Metacognitive therapy</keyword>
  <keyword>Work focused interventions</keyword>
  <keyword>Sick leave</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic 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/NCT03301922
org study id: 2015/1794
nct id: NCT03301922
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Common mental health disorders such as anxiety and depression are leading causes of sickness
      absence and disability in Norway. Despite tremendous costs for individual and society,
      effective treatment is lacking. Mental health interventions do not typically target work
      situation, despite its importance for patient well-being. On a policy level, effective
      measures are impeded by a paucity of scientific data, and programs designed to address the
      issue such as Faster Return to Work ("Raskere tilbake") lack evaluation. The present project
      will test the effectiveness of Metacognitive therapy and work-focused interventions for
      reducing sick leave in patients with common mental disorders.
Common mental health disorders (CMD) such as anxiety and depression are leading contributors
      to the global burden of disease , generating substantial costs for societies in reduced
      productivity and increased benefit pay outs. In 2010, the worldwide cost of mental health
      disability was estimated at US$2.5-8.5 trillion in lost output, and the sum is projected to
      double by 2030 unless effective policy measures are implemented. For middle- and high-income
      countries, 30-50 % of disability applications stem from mental health issues, and the
      proportion is likely greater among the younger part of the work force. In Europe, depression
      is responsible for 13.7 % of all years lived with disability, and anxiety disorders likely
      have similar impact. Mental health issues are among the leading causes of disability and
      early retirement across the European region.

      For affected individuals, anxiety and depression reduces quality of life, decreases
      functioning and increases the risk of further health problems. Sick leave is often used for
      adults with CMD, but may not always be helpful. Avoidance and isolation are behavioural
      strategies that maintain anxiety and depression. Absenteeism from work, an important social
      arena, may strengthen this behaviour, impeding recovery. Even when controlling for the impact
      of ill health, short term sick leave may in itself increase the risk of future long term
      absence. In addition, employment rates are 10-15% lower for people with mental ill health
      than the rest of the population. Exclusion from the work force is in turn associated with
      poorer mental health, and can heighten the risk of futures depression and even suicide. The
      relationship between CMD and reduced work-participation is therefore likely bidirectional,
      and sick leave may not work as intended despite its high cost for society.

      The individual and societal burden from sick leave and mental health represents a key policy
      challenge on the global agenda and the need for efficient measures is urgent. Norway
      exemplifies this urgent need as expenditure on disability and sickness absence totals 5 % of
      GDP, by far the highest in the OECD. Efforts have been made to address the issue through
      several policy initiatives, such as the nationwide Faster Return to Work (FRW) program. The
      program facilitates buying treatment from different actors to reduce waiting times and thus
      potentially the duration of sick leave. The impact of the program is uncertain, as little
      research has been done on its efficacy. Scientific data on Norwegian sick leave follow up is
      mostly absent. Despite the magnitude of the challenge, there is a clear knowledge gap.

      Investment in sick leave follow up has not been equally distributed amongst patient groups.
      Sixty per cent of all working days lost to disability or sick leave are due to mental health
      issues and musculoskeletal complaints. Sick leave due to CMD is growing. When caused by
      mental health issues, disability pension is awarded on average nine years earlier than for
      somatic reasons, resulting in more working years lost to disability. Though prevalent in the
      statistics, few CMD patients on sick leave receive treatment. Only 1.4 % of employees on sick
      leave are referred to specialized mental health treatment. As many as one in three people
      awarded disability pension for mental illness have never received any form of treatment prior
      to disability being granted. This shows a severe under-referral and under-treatment for this
      patient group despite being responsible for the majority of sick leave and disability costs.

      A more targeted approach, integrating work-focused interventions with effective CMD treatment
      is needed for this patient group. Two recent studies have examined such an approach. In the
      Netherlands, Lagerveld and Blonk conducted a randomized controlled trial where 168 patients
      on sick leave due to CMD received either cognitive behavioural therapy (CBT), or CBT with an
      integrated work-focused intervention. Their results showed a 20 % decrease in sickness
      absence for patients receiving the work-focused intervention, while maintaining effective
      symptom reduction. In Germany, similar results were found with a smaller sample size. A
      multicentre trial in Norway looked at registry data for 1193 CMD patients receiving a
      variation of work-specific interventions, showing a clear reduction in sick leave and
      disability. Integrated work-focused treatment for CMD is thus a promising avenue of research.

      Metacognitive therapy (MCT) is a treatment based on more recent theoretical developments. It
      has shown excellent results for anxiety and depression, and the treatment protocol for
      generalized anxiety disorder and social phobia is recommended in the NICE guidelines. Rather
      than challenging and changing specific thought content (CBT), metacognitive treatment aims to
      change and challenge maladaptive cognitive processes, among these rumination and worry, which
      are key components in CMD and sick leave.

      The study will be a randomized controlled trial. Participants will be persons with a primary
      diagnosis of common mental disorders, anxiety and depression. Experienced independent
      diagnosticians will assess all patients by using structural interviews MINI (MINI
      International Neuropsychiatric Interview).

      All patients will be randomized in blocks to two groups in order to compare the following
      conditions: MCT and work-focused interventions, and a wait list control condition. After the
      waiting period of either 8 or 12 weeks, the patients in the wait-list condition will be
      allocated to the treatment condition. Both between-subjects and within-subjects comparisons
      will be conducted.

      Questions that will be addressed are:

        1. MCT and work-focused interventions will be superior to the wait-list condition in make
           participants return to work

        2. Which changes in predictors related to treatment predict return to work

        3. MCT and work-focused interventions will be superior to the wait-list condition for
           improving mental health

        4. MCT and work-focused interventions will be more cost-efficient than the wait-list
           condition

        5. Evaluate the sustainability of return to work for patients on sick leave due to common
           mental disorders after MCT and work-focused interventions

        6. Examine impact of different potential prognostic factors on work function, both at the
           end of treatment and at one year follow-up.

        7. If the effect of MCT and work-focused interventions will sustain one year after the end
           of therapy

        8. Explore if patients will have reduced use of sick leave in the four years following
           after treatment compared to the two years prior to treatment based on register data.

      The meta-cognitive treatment program is based on Wells' manual. The work-focused intervention
      is based on an adopted Norwegian version of Lagerveld and Blonk. The interventions are run in
      parallel. The patients who are receiving MCT and work-focused interventions will be treated
      up to maximum 12 sessions, with weekly session of 45-60 minute duration.

      The treatment will be administered according to the originators published treatment protocols
      for MCT.

        1. All patients referred to the clinic will be consecutively assessed at intake (MINI).
           Based on diagnosis and criteria for inclusion and exclusion, the patients will be asked
           to volunteer to participate in the study and confirm by signing a form of consent.

        2. Patients will be randomized to one of the two conditions.

        3. Patients will be asked to self-rate symptoms on a battery of self-report questionnaires.

        4. Work-focused meta-cognitive therapy will be given to patients in group 1, while group 2
           is a waiting list control. Waiting list controls will be rated but not treated and will
           wait for treatment for either 8 or 12 weeks.

        5. After waiting they will be transferred to the treatment group.

        6. The patients will be assessed prior to treatment, by at end of treatment weeks in
           treatment, and at six months and at, one and two years of follow-up.

        7. Reassessment of the diagnosis and symptom severity is made by post-treatment.

      Criteria for recovery will be: Jacobsen criteria of a minimum change and patients crossing
      the cut-off point on two measures: The BDI and BAI. Other outcome measures will include:

        -  Reduction of depressive symptoms as measured by self-report questionnaires

        -  Number of patients with no diagnosis based on MINI after treatment

        -  Relapse rate during six months and at, one year follow-up

      A comparison between the two groups of patients will be conducted at post-treatment.
      Follow-up data will be analysed based on 6 month and at one year of follow up for the
      treatment condition with self-report and a four year follow-up with register data. A within
      group analyses will be conducted in order to estimate effect sizes and significant clinical
      change estimates.

      Participants will be randomized in patients divided on three conditions in a 1:2 ratio. One
      factors are controlled for in the randomization, namely, gender. A computer program provided
      by NTNU WebCRF will generate the randomization list.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised Controlled Trial
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in degree of sick leave
time frame: From 2 years prior to intervention - to 4 years after intervention
description: data from National registers
measure: Changes in degree of sick leave
time frame: From 2 years prior to intervention - to 4 years after intervention
description: data from patients self-report
measure: Changes in anxiety symptoms
time frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
description: Changes in depressive symptoms measured by Beck Anxiety Inventory (BAI)
measure: Changes in depressive symptoms
time frame: From pre treatment, to post treatment (12 weeks), 6 months 1 year follow-up
description: Changes in depressive symptoms measured by Beck Depression Inventory II (BDI-II)
measure: Changes in metacognitions
time frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
description: Changes in metacognitions symptoms measured by the Metacognitions Questionnaire 30 (MCQ-30)
measure: Changes in subjective health complaints
time frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
description: Changes in symptoms measured by Subjective Health Complaints
measure: Changes in bullying and victimisation at work
time frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
description: Changes in measured Negative Acts Questionnaire
measure: Changes in self-efficacy
time frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
description: Changes measured with Return to work self-efficacy
measure: Changes in resilience
time frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
description: Changes measured with The resilience scale for adults (RSA)
measure: Changes in quality of life
time frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
description: Changes measured with EQ-5D-5L
measure: MINI - diagnostic interview
time frame: From pre treatment, to post treatment (12 weeks)
description: Diagnostic evaluations using MINI - International Neuropsychiatric Interview
measure: Secondary analysis related to the onset of Covid-19
time frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
description: Sub-analyses taking into consideration the onset of Covid-19 in Norway by mid March 2020
arm group label: Work-focused metacognitive therapy
arm group type: Experimental
description: Work-focused metacognitive therapy
arm group label: Waiting list
arm group type: Other
description: Waiting list
intervention type: Behavioral
intervention name: Metacognitive therapy and work-focused interventions
description: Metacognitive therapy and work-focused interventions, up to maximum 12 sessions, with weekly session of 45-60 minute duration. The metacognitive treatment program is based on Wells' manual. The work-focused intervention is based on Lagerveld and Blonk. The interventions are run in parallel.
arm group label: Waiting list
arm group label: Work-focused metacognitive therapy
intervention type: Other
intervention name: Waiting list
description: Waiting list
arm group label: Waiting list
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Odin Hjemdal, prof
role: Principal Investigator
affiliation: Norwegian University of Science and Technology
last name: Ragne GH Gjengedal
role: Study Chair
affiliation: Diakonhjemmet Hospital
last name: Odin Hjemdal, prof
phone: 0047 73597889
email: odin.hjemdal@ntnu.no
facility: 
status: Recruiting
contact: 
country: Norway
responsible party type: Sponsor
mesh term: Mental Disorders
mesh term: Psychotic Disorders
sharing ipd: No