<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/NCT04457635</url>
  </required_header>
  <id_info>
    <org_study_id>HVestfold</org_study_id>
    <nct_id>NCT04457635</nct_id>
  </id_info>
  <brief_title>Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders.</brief_title>
  <official_title>Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders. A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital of Vestfold</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital of Vestfold</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>
      This study is a pragmatic randomized controlled trial (RCT) evaluating the effect of brief&#xD;
      versus short psychotherapy in subjects with substantial mental complaints.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Running evaluations of the brief intervention (BI) at our outpatient clinic preceding to this&#xD;
      study had given us the impression that the patients obtained a more active coping style&#xD;
      towards their health problems with consequential enhanced work participation (WP). These&#xD;
      evaluations, in addition to our experiences in BI for low back pain (LBP) has generated the&#xD;
      current hypothesis of this study towards WP. Yet, the sustainability of WP and long-term&#xD;
      effects on mental health remained questionable. In this pragmatic RCT the objective was to&#xD;
      compare brief psychotherapy with focus on normalization and coping (Brief-PsT) with&#xD;
      short-term psychotherapy of standard duration with more extended focus (Short-PsT), as&#xD;
      otherwise used at the Mental Health services. The primary aim of this study was to assess&#xD;
      differences in effect on WP and the secondary aim was to assess differences in clinical&#xD;
      response. The investigators hypothesized that in the short term, Brief-PsT could facilitate&#xD;
      or sustain WP in a superior fashion to Short-PsT in persons who are on, or at risk of sick&#xD;
      leave due to mental health problems. Although the investigators expected a substantial&#xD;
      long-term rate of clinical recovery and reduction in mental health-related symptoms in both&#xD;
      groups, the investigators had no specific hypothesis regarding the extent and direction of&#xD;
      possible group differences in these clinical measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2013</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">September 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>
    <intervention_model_description>Pragmatic randomized controled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome assessor of primary outcome (sickness benefit) is masked for intervention allocation. Other outcome measures are assessed by patient questionnaires.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Return to Work (RTW) to 3 months follow-up</measure>
    <time_frame>baseline - 3 months</time_frame>
    <description>Transitions from baseline to 3 months follow-up in Work Participation degree</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Return to Work (RTW) to 1 year follow-up</measure>
    <time_frame>baseline - 1 year</time_frame>
    <description>Transitions from baseline to 1 year follow-up in Work Participation degree</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Return to Work (RTW) to 2 year follow-up</measure>
    <time_frame>baseline - 2 year</time_frame>
    <description>Transitions from baseline to 2 year follow-up in Work Participation degree</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical recovery</measure>
    <time_frame>2 years</time_frame>
    <description>A minimal score on both Beck Inventories (BDI ≤ 13 and BAI ≤ 9)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Beck Depression Index - II (BDI)</measure>
    <time_frame>baseline, 2 year follow-up</time_frame>
    <description>Score 0-63, higher scores mean worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Beck Anxiety Index (BAI)</measure>
    <time_frame>baseline, 2 year follow-up</time_frame>
    <description>Score 0-63, higher scores mean worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Hopkins Symptoms Checklist-10</measure>
    <time_frame>baseline, 2 year follow-up</time_frame>
    <description>Score 1-4, higher scores mean worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Subjective health complaints (SHC)</measure>
    <time_frame>baseline, 2 year follow-up</time_frame>
    <description>Score 0-29, higher scores mean worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-efficacy (GSES)</measure>
    <time_frame>baseline - 2 year follow-up</time_frame>
    <description>Score 1-4 , lower scores means worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Lfe satisfaction (LISAT)</measure>
    <time_frame>baseline - 2 year follow-up</time_frame>
    <description>Score 1-6, lower scores means worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Illness perception (bIPC)</measure>
    <time_frame>baseline - 2 year follow-up</time_frame>
    <description>Score 1-10, higher scores mean worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Fear avoidance beliefs -work (FABQ-work)</measure>
    <time_frame>baseline - 2 year follow-up</time_frame>
    <description>Score 0-7, higher scores mean worse outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Global Perceived Effect</measure>
    <time_frame>2 year follow-up</time_frame>
    <description>Score 0-7, lower scores means worse outcome</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Mental Disorder</condition>
  <arm_group>
    <arm_group_label>Brief psychotherapy (brief PsT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The focus was on normalizing, accepting and coping with their present mental health complaints and their hindrance for work participation. Primarily, there was no intention to process previous pathogenic experiences. The standard duration was set on six sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Short psychotherapy (short-PsT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>With more extended focus, there was besides coping of mental health and challenges concerning WP, an emphasis on both an extensive anamnesis and possibility to establish a so-called central theme based on previous or current challenging issues such as trauma, difficult childhood conditions, and personality-related issues. Additional aims of the intervention could include reducing symptoms and problematic behaviour and an improvement of home situation, with deeper focus on cognitive maladaptive coping strategies or dynamic repetitions. The number of sessions was aimed to be 20 on average</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychotherapy</intervention_name>
    <arm_group_label>Brief psychotherapy (brief PsT)</arm_group_label>
    <arm_group_label>Short psychotherapy (short-PsT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  'mental complaints' was the main reason for referral to the outpatient clinic&#xD;
&#xD;
          -  employed and on or at risk of sick leave&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute or severe pathology that required greater input than the clinic could offer,&#xD;
&#xD;
          -  Sick-leave had &gt; 9 months during the preceding 2 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aage Indahl, Prof.Dr</last_name>
    <role>Study Director</role>
    <affiliation>Vestfol Hospital Trust</affiliation>
  </overall_official>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital of Vestfold</investigator_affiliation>
    <investigator_full_name>Aage Indahl</investigator_full_name>
    <investigator_title>professor emeritus</investigator_title>
  </responsible_party>
  <keyword>Return to Work</keyword>
  <keyword>Brief Intervention</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/NCT04457635
org study id: HVestfold
nct id: NCT04457635
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a pragmatic randomized controlled trial (RCT) evaluating the effect of brief
      versus short psychotherapy in subjects with substantial mental complaints.
Running evaluations of the brief intervention (BI) at our outpatient clinic preceding to this
      study had given us the impression that the patients obtained a more active coping style
      towards their health problems with consequential enhanced work participation (WP). These
      evaluations, in addition to our experiences in BI for low back pain (LBP) has generated the
      current hypothesis of this study towards WP. Yet, the sustainability of WP and long-term
      effects on mental health remained questionable. In this pragmatic RCT the objective was to
      compare brief psychotherapy with focus on normalization and coping (Brief-PsT) with
      short-term psychotherapy of standard duration with more extended focus (Short-PsT), as
      otherwise used at the Mental Health services. The primary aim of this study was to assess
      differences in effect on WP and the secondary aim was to assess differences in clinical
      response. The investigators hypothesized that in the short term, Brief-PsT could facilitate
      or sustain WP in a superior fashion to Short-PsT in persons who are on, or at risk of sick
      leave due to mental health problems. Although the investigators expected a substantial
      long-term rate of clinical recovery and reduction in mental health-related symptoms in both
      groups, the investigators had no specific hypothesis regarding the extent and direction of
      possible group differences in these clinical measurements.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pragmatic randomized controled trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcome assessor of primary outcome (sickness benefit) is masked for intervention allocation. Other outcome measures are assessed by patient questionnaires.
measure: Change in Return to Work (RTW) to 3 months follow-up
time frame: baseline - 3 months
description: Transitions from baseline to 3 months follow-up in Work Participation degree
measure: Change in Return to Work (RTW) to 1 year follow-up
time frame: baseline - 1 year
description: Transitions from baseline to 1 year follow-up in Work Participation degree
measure: Change in Return to Work (RTW) to 2 year follow-up
time frame: baseline - 2 year
description: Transitions from baseline to 2 year follow-up in Work Participation degree
measure: Clinical recovery
time frame: 2 years
description: A minimal score on both Beck Inventories (BDI ≤ 13 and BAI ≤ 9)
measure: Beck Depression Index - II (BDI)
time frame: baseline, 2 year follow-up
description: Score 0-63, higher scores mean worse outcome
measure: Beck Anxiety Index (BAI)
time frame: baseline, 2 year follow-up
description: Score 0-63, higher scores mean worse outcome
measure: Hopkins Symptoms Checklist-10
time frame: baseline, 2 year follow-up
description: Score 1-4, higher scores mean worse outcome
measure: Subjective health complaints (SHC)
time frame: baseline, 2 year follow-up
description: Score 0-29, higher scores mean worse outcome
measure: Self-efficacy (GSES)
time frame: baseline - 2 year follow-up
description: Score 1-4 , lower scores means worse outcome
measure: Lfe satisfaction (LISAT)
time frame: baseline - 2 year follow-up
description: Score 1-6, lower scores means worse outcome
measure: Illness perception (bIPC)
time frame: baseline - 2 year follow-up
description: Score 1-10, higher scores mean worse outcome
measure: Fear avoidance beliefs -work (FABQ-work)
time frame: baseline - 2 year follow-up
description: Score 0-7, higher scores mean worse outcome
measure: Global Perceived Effect
time frame: 2 year follow-up
description: Score 0-7, lower scores means worse outcome
arm group label: Brief psychotherapy (brief PsT)
arm group type: Experimental
description: The focus was on normalizing, accepting and coping with their present mental health complaints and their hindrance for work participation. Primarily, there was no intention to process previous pathogenic experiences. The standard duration was set on six sessions.
arm group label: Short psychotherapy (short-PsT)
arm group type: Active Comparator
description: With more extended focus, there was besides coping of mental health and challenges concerning WP, an emphasis on both an extensive anamnesis and possibility to establish a so-called central theme based on previous or current challenging issues such as trauma, difficult childhood conditions, and personality-related issues. Additional aims of the intervention could include reducing symptoms and problematic behaviour and an improvement of home situation, with deeper focus on cognitive maladaptive coping strategies or dynamic repetitions. The number of sessions was aimed to be 20 on average
intervention type: Behavioral
intervention name: Psychotherapy
arm group label: Brief psychotherapy (brief PsT)
arm group label: Short psychotherapy (short-PsT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 67 Years
healthy volunteers: No
last name: Aage Indahl, Prof.Dr
role: Study Director
affiliation: Vestfol Hospital Trust
responsible party type: Principal Investigator
investigator affiliation: The Hospital of Vestfold
investigator full name: Aage Indahl
investigator title: professor emeritus
mesh term: Mental Disorders
mesh term: Psychotic Disorders
sharing ipd: No