<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/NCT01667809</url>
  </required_header>
  <id_info>
    <org_study_id>GVC CBT vs RTW II</org_study_id>
    <nct_id>NCT01667809</nct_id>
  </id_info>
  <brief_title>CBT vs RTW Intervention for Patients With Common Subclinical Mental Illness in Primary Care</brief_title>
  <official_title>Cognitive Behavior Therapy Versus a Return to Work Intervention for Sick-listed Patients With Subclinical Common Mental Illness in Primary Care: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Stockholm</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Common mental illness, such as anxiety disorders and depression, is the main&#xD;
      cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be&#xD;
      effective in alleviating target symptoms of these disorders, but its effect on sick leave&#xD;
      rates has not been sufficiently addressed. The investigators have developed an intervention&#xD;
      called return to work (RTW), which is based in cognitive behavioral theory, that has a&#xD;
      primary aim of helping sick-listed patients with common mental illness return to work. This&#xD;
      new treatment has not been evaluated in a randomized controlled trial.&#xD;
&#xD;
      Aims: The aim of this study is to investigate the effect of CBT and RTW for subclinical&#xD;
      common mental illness in a randomized controlled trial conducted in primary care.&#xD;
      Participants will be randomized to diagnosis specific CBT (n=50), RTW (n=50. Main outcomes&#xD;
      are days of sick leave and clinician severity rating of psychiatric symptoms. This study&#xD;
      could contribute to new knowledge regarding how to best treat patients on sick leave with&#xD;
      mild common mental illness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sick leave</measure>
    <time_frame>1 year</time_frame>
    <description>Number of days on sick leave</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinician Severity Rating (CSR)</measure>
    <time_frame>Baseine, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in CSR at post-treatment, 26 week follow-up, and 52 week follow-up compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average) 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Anxiety Inventory (HAI)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Inventory (QOLI)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average) 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in QOLI at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol-5 dimension (EQ5D)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average) 26 feel follow-up, 52 week follow-up</time_frame>
    <description>Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sheehan Disability Scales (SDS)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in SDS at post-treatment, 26 week follow-up, and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated health 5 (SRH-5)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obsessive Compulsive Inventory-Revised (OCI-R)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liebowitz Social Anxiety Scale Self-report (LSAS-SR)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Panic Disorder Severity Scale Self-rated (PDSS-SR)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn-State Worry Questionnaire (PSWQ)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Traumatic Stress Disorder Symptom Scale-Self report (PTSDSS)</measure>
    <time_frame>Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up</time_frame>
    <description>Change in PTSDSS at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Anxiety Disorders</condition>
  <condition>Major Depression</condition>
  <condition>Stress Disorders</condition>
  <condition>Primary Insomnia</condition>
  <arm_group>
    <arm_group_label>Cognitive Behavior Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>As the trial will include several different common subclinical mental disorders, the cognitive behavior therapy used in the study will be based on the protocols with best empirical support. Cognitive behavior therapy entails psychoeducational components, i.e. the patient is learns about the disorder and how to view it from a cognitive behavioral perspective. The most important part of the treatment is systematic behavior changes often targeted at exposure to feared stimuli. This is combined with cognitive interventions targeted at challenging negative automatic thoughts. All treatments will be delivered by licensed psychologists.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Return to work</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm will receive an experimental treatment, based in cognitive behavioral therapy, with primary aim to help patients return to work. Interventions are aimed at solving work-related problems and comprises problem-solving training and systematic employer-patient meetings aimed at facilitating a gradual return to the workplace. Licensed psychologists deliver all treatments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavior therapy</intervention_name>
    <description>Cognitive behavior therapy entails psychoeducational components, i.e. the patient is learns about the disorder and how to view it from a cognitive behavioral perspective. The most important part of the treatment is systematic behavior changes often targeted at exposure to feared stimuli. This is combined with cognitive interventions targeted at challenging negative automatic thoughts. All treatments will be delivered by licensed psychologists.</description>
    <arm_group_label>Cognitive Behavior Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Return to work</intervention_name>
    <description>Participants randomized to this arm will receive an experimental treatment, based in cognitive behavioral therapy, with primary aim to help patients return to work. Interventions are aimed at solving work-related problems and comprises problem-solving training and systematic employer-patient meetings aimed at facilitating a gradual return to the workplace. Licensed psychologists deliver all treatments.</description>
    <arm_group_label>Return to work</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have been on sick leave (at least 50%) for at least 1 month and not more than 6 months&#xD;
&#xD;
          -  Have subclinical levels of anxiety disorder diagnosis (obsessive compulsive disorder,&#xD;
             social phobia, panic disorder, generalized anxiety disorder, post-traumatic stress&#xD;
             disorder, specific phobia), or/and major depression, or/and maladaptive stress&#xD;
             reaction, or/and primary insomnia. Severity measured by clinical severity rating (CSR)&#xD;
             2-3 for mild subclinical level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A higer score than 3 on the Clinician severity rating scale&#xD;
&#xD;
          -  A lower score than 2 on the Clinician severity rating scale&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Karolinska Institutet and Gustavsberg primary care center</name>
      <address>
        <city>Stockholm,</city>
        <state>Stockholm</state>
        <zip>13440</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>March 2, 2016</last_update_submitted>
  <last_update_submitted_qc>March 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Erik Hedman</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01667809
org study id: GVC CBT vs RTW II
nct id: NCT01667809
lead sponsor: 
collaborator: 
has dmc: No
Background: Common mental illness, such as anxiety disorders and depression, is the main
      cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be
      effective in alleviating target symptoms of these disorders, but its effect on sick leave
      rates has not been sufficiently addressed. The investigators have developed an intervention
      called return to work (RTW), which is based in cognitive behavioral theory, that has a
      primary aim of helping sick-listed patients with common mental illness return to work. This
      new treatment has not been evaluated in a randomized controlled trial.

      Aims: The aim of this study is to investigate the effect of CBT and RTW for subclinical
      common mental illness in a randomized controlled trial conducted in primary care.
      Participants will be randomized to diagnosis specific CBT (n=50), RTW (n=50. Main outcomes
      are days of sick leave and clinician severity rating of psychiatric symptoms. This study
      could contribute to new knowledge regarding how to best treat patients on sick leave with
      mild common mental illness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Sick leave
time frame: 1 year
description: Number of days on sick leave
measure: Clinician Severity Rating (CSR)
time frame: Baseine, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
description: Change in CSR at post-treatment, 26 week follow-up, and 52 week follow-up compared to baseline.
measure: Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)
time frame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
description: Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up
measure: Insomnia Severity Index (ISI)
time frame: Baseline, post-treatment (12 weeks on average) 26 week follow-up, 52 week follow-up
description: Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up
measure: Health Anxiety Inventory (HAI)
time frame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
description: Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up
measure: Perceived Stress Scale (PSS)
time frame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
description: Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up
measure: Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)
time frame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
description: Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up
measure: Quality of Life Inventory (QOLI)
time frame: Baseline, post-treatment (12 weeks on average) 26 week follow-up, 52 week follow-up
description: Change in QOLI at post-treatment, 26 week follow-up, and 52 week follow-up
measure: EuroQol-5 dimension (EQ5D)
time frame: Baseline, post-treatment (12 weeks on average) 26 feel follow-up, 52 week follow-up
description: Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up
measure: Sheehan Disability Scales (SDS)
time frame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
description: Change in SDS at post-treatment, 26 week follow-up, and 52 week follow-up
measure: Self-rated health 5 (SRH-5)
time frame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
description: Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up
measure: Obsessive Compulsive Inventory-Revised (OCI-R)
time frame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
description: Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
measure: Liebowitz Social Anxiety Scale Self-report (LSAS-SR)
time frame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
description: Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
measure: Panic Disorder Severity Scale Self-rated (PDSS-SR)
time frame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
description: Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
measure: Penn-State Worry Questionnaire (PSWQ)
time frame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
description: Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
measure: Post Traumatic Stress Disorder Symptom Scale-Self report (PTSDSS)
time frame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
description: Change in PTSDSS at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
arm group label: Cognitive Behavior Therapy
arm group type: Active Comparator
description: As the trial will include several different common subclinical mental disorders, the cognitive behavior therapy used in the study will be based on the protocols with best empirical support. Cognitive behavior therapy entails psychoeducational components, i.e. the patient is learns about the disorder and how to view it from a cognitive behavioral perspective. The most important part of the treatment is systematic behavior changes often targeted at exposure to feared stimuli. This is combined with cognitive interventions targeted at challenging negative automatic thoughts. All treatments will be delivered by licensed psychologists.
arm group label: Return to work
arm group type: Experimental
description: Participants randomized to this arm will receive an experimental treatment, based in cognitive behavioral therapy, with primary aim to help patients return to work. Interventions are aimed at solving work-related problems and comprises problem-solving training and systematic employer-patient meetings aimed at facilitating a gradual return to the workplace. Licensed psychologists deliver all treatments.
intervention type: Behavioral
intervention name: Cognitive behavior therapy
description: Cognitive behavior therapy entails psychoeducational components, i.e. the patient is learns about the disorder and how to view it from a cognitive behavioral perspective. The most important part of the treatment is systematic behavior changes often targeted at exposure to feared stimuli. This is combined with cognitive interventions targeted at challenging negative automatic thoughts. All treatments will be delivered by licensed psychologists.
arm group label: Cognitive Behavior Therapy
intervention type: Behavioral
intervention name: Return to work
description: Participants randomized to this arm will receive an experimental treatment, based in cognitive behavioral therapy, with primary aim to help patients return to work. Interventions are aimed at solving work-related problems and comprises problem-solving training and systematic employer-patient meetings aimed at facilitating a gradual return to the workplace. Licensed psychologists deliver all treatments.
arm group label: Return to work
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Erik Hedman
investigator title: Principal investigator
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Anxiety Disorders
mesh term: Mental Disorders