<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/NCT01731717</url>
  </required_header>
  <id_info>
    <org_study_id>01KQ1002B-TP7</org_study_id>
    <nct_id>NCT01731717</nct_id>
  </id_info>
  <brief_title>Cluster Randomized Trial of Stepped Care Intervention vs. Treatment as Usual for Patients With Depression</brief_title>
  <acronym>SCM</acronym>
  <official_title>Effektivität Und Effizienz Von Behandlungspfaden für Patienten Mit Depressiven Erkrankungen: Stepped Care Als Ansatz für Ein Leitliniengerechtes Und Integriertes Versorgungsmanagement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of the project is the implementation and evaluation of a stepped care model&#xD;
      (SCM) for patients with depression with 6 treatment options of varying intensity and setting,&#xD;
      including innovative technologies (e-mental health, telephone-based psychotherapy). Within&#xD;
      this complex intervention, patients are treated by a multiprofessional network of health care&#xD;
      providers in Hamburg, Germany. The study compares the SCM condition (intervention group) to a&#xD;
      control group receiving treatment as usual (cluster randomization on the level of&#xD;
      participating general practitioners). It is expected that the SCM condition will show better&#xD;
      results regarding reduction of mental symptoms, improvement of quality of life, more&#xD;
      efficient access to care and better cost-benefit ratio.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in depression severity (PHQ-D-9)</measure>
    <time_frame>Baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Change in patient-rated depression symptom severity: Patient Health Questionnaire 9, German version (PHQ-D-9; Löwe, Zipfel &amp; Herzog, 2002)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost-benefit ratio (QALYs)</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Cost-benefit ratio in quality-adjusted life years(QALYs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response/Remission/Relapse (PHQ-D-9)</measure>
    <time_frame>Baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Response/Remission/Relapse as computed by the difference in pre-post depression severity (PHQ-D-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (EQ-5D)</measure>
    <time_frame>Baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Quality of life as measured by EuroQol's EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (SF-12)</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months</time_frame>
    <description>Quality of life as measured by the 12-item Short Form Health Survey (SF-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health service utilization and medication consumption</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Non-standardized items regarding the amount and cost of health services utilized in the past 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-esteem</measure>
    <time_frame>Baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Rosenberg self-esteem scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic alliance</measure>
    <time_frame>Baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Patient-rated therapeutic alliance as measured by the Helping Alliace Questionnaire (HAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms (PHQ-D)</measure>
    <time_frame>Baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Anxiety as rated by the PHQ-D anxiety scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Panic symptoms (PHQ-D)</measure>
    <time_frame>Baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Panic symptoms as measured by the PHQ-D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Somatisation (PHQ-D)</measure>
    <time_frame>Baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Somatisation as measured by the PHQ-D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General anxiety disorder (GAD-7)</measure>
    <time_frame>Baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Symptoms of general anxiety disorder measured by the GAD-7</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">737</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Stepped care intervention (SCM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients within the stepped care intervention are screened by general physician using the PHQ-9 (inclusion criterion: &gt;4 points) and diagnosed according to International Classification of Diseases (ICD-10) criteria. Patients receive differentially intensive treatment according to depression severity.&#xD;
Patients with mild depression receive:&#xD;
Step I: Active monitoring or Step II: II.a. Bibliotherapy or II.b. Online self-help (&quot;Deprexis®&quot;) or II+: Telephone-based psychotherapy&#xD;
Patients with moderate depression receive:&#xD;
Step III: III.a. Outpatient psychotherapy or III.b. Psychopharmacological treatment&#xD;
Patients with severe depression receive:&#xD;
Step IV: Combined psychotherapy and psychopharmacological treatment, optionally in inpatient setting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group: treatment as usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the control group are screened by their general physician using the PHQ-D-9 depression scale. Patients included in the study then receive treatment as usual from general physician or other health service providers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active monitoring</intervention_name>
    <description>General physician performs monitoring every 2 weeks using the PHQ-9 depression scale.</description>
    <arm_group_label>Stepped care intervention (SCM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Bibliotherapy</intervention_name>
    <description>Patient works with self-help book &quot;Selbsthilfe bei Depressionen&quot; (Görlitz, 2010) under general physician's supervision.</description>
    <arm_group_label>Stepped care intervention (SCM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online self-help</intervention_name>
    <description>Patient works with online self-help program &quot;Deprexis&quot; under general physician's supervision.</description>
    <arm_group_label>Stepped care intervention (SCM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Outpatient psychotherapy</intervention_name>
    <description>Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network.</description>
    <arm_group_label>Stepped care intervention (SCM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Psychiatric treatment</intervention_name>
    <description>Patient receives treatment from psychiatrist or general physician participating in the network, this includes psychopharmacotherapy. Treatment takes place within routine care, thus psychiatrists or general physicians individually determine the type of medication and are committed to follow the recommendations of the German S3-Guideline/National Disease Management Guideline for Unipolar Depression.</description>
    <arm_group_label>Stepped care intervention (SCM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Combined psychotherapy and psychopharmacological treatment</intervention_name>
    <description>Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.</description>
    <arm_group_label>Stepped care intervention (SCM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group: treatment as usual</intervention_name>
    <description>treatment as usual</description>
    <arm_group_label>Control group: treatment as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;4 points on PHQ-D-9 depression scale&#xD;
&#xD;
          -  sufficient knowledge of German language&#xD;
&#xD;
          -  health situation that allows questionnaire completion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  insufficient knowledge of German language&#xD;
&#xD;
          -  health situation not allowing questionnaire completion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Birgit Watzke, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin Härter, Prof. Dr. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.psychenet.de/ueber-psychenet/teilprojekte/depression.html</url>
    <description>Project homepage</description>
  </link>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>July 10, 2015</last_update_submitted>
  <last_update_submitted_qc>July 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitätsklinikum Hamburg-Eppendorf</investigator_affiliation>
    <investigator_full_name>PD Dr. phil. Birgit Watzke</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>depression</keyword>
  <keyword>stepped care</keyword>
  <keyword>evidence-based medicine</keyword>
  <keyword>health services research</keyword>
  <keyword>psychotherapy</keyword>
  <keyword>complex intervention</keyword>
  <keyword>guideline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT01731717
org study id: 01KQ1002B-TP7
nct id: NCT01731717
lead sponsor: 
has dmc: No
The main aim of the project is the implementation and evaluation of a stepped care model
      (SCM) for patients with depression with 6 treatment options of varying intensity and setting,
      including innovative technologies (e-mental health, telephone-based psychotherapy). Within
      this complex intervention, patients are treated by a multiprofessional network of health care
      providers in Hamburg, Germany. The study compares the SCM condition (intervention group) to a
      control group receiving treatment as usual (cluster randomization on the level of
      participating general practitioners). It is expected that the SCM condition will show better
      results regarding reduction of mental symptoms, improvement of quality of life, more
      efficient access to care and better cost-benefit ratio.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in depression severity (PHQ-D-9)
time frame: Baseline, 3 months, 6 months, 12 months
description: Change in patient-rated depression symptom severity: Patient Health Questionnaire 9, German version (PHQ-D-9; Löwe, Zipfel & Herzog, 2002)
measure: Cost-benefit ratio (QALYs)
time frame: Baseline, 6 months, 12 months
description: Cost-benefit ratio in quality-adjusted life years(QALYs)
measure: Response/Remission/Relapse (PHQ-D-9)
time frame: Baseline, 3 months, 6 months, 12 months
description: Response/Remission/Relapse as computed by the difference in pre-post depression severity (PHQ-D-9)
measure: Quality of life (EQ-5D)
time frame: Baseline, 3 months, 6 months, 12 months
description: Quality of life as measured by EuroQol's EQ-5D
measure: Quality of life (SF-12)
time frame: Baseline, 3 months, 6 months, 9 months
description: Quality of life as measured by the 12-item Short Form Health Survey (SF-12)
measure: Health service utilization and medication consumption
time frame: Baseline, 6 months, 12 months
description: Non-standardized items regarding the amount and cost of health services utilized in the past 6 months
measure: Self-esteem
time frame: Baseline, 3 months, 6 months, 12 months
description: Rosenberg self-esteem scale
measure: Therapeutic alliance
time frame: Baseline, 3 months, 6 months, 12 months
description: Patient-rated therapeutic alliance as measured by the Helping Alliace Questionnaire (HAQ)
measure: Anxiety symptoms (PHQ-D)
time frame: Baseline, 3 months, 6 months, 12 months
description: Anxiety as rated by the PHQ-D anxiety scale
measure: Panic symptoms (PHQ-D)
time frame: Baseline, 3 months, 6 months, 12 months
description: Panic symptoms as measured by the PHQ-D
measure: Somatisation (PHQ-D)
time frame: Baseline, 3 months, 6 months, 12 months
description: Somatisation as measured by the PHQ-D
measure: General anxiety disorder (GAD-7)
time frame: Baseline, 3 months, 6 months, 12 months
description: Symptoms of general anxiety disorder measured by the GAD-7
arm group label: Stepped care intervention (SCM)
arm group type: Experimental
description: Patients within the stepped care intervention are screened by general physician using the PHQ-9 (inclusion criterion: >4 points) and diagnosed according to International Classification of Diseases (ICD-10) criteria. Patients receive differentially intensive treatment according to depression severity.
Patients with mild depression receive:
Step I: Active monitoring or Step II: II.a. Bibliotherapy or II.b. Online self-help ("Deprexis®") or II+: Telephone-based psychotherapy
Patients with moderate depression receive:
Step III: III.a. Outpatient psychotherapy or III.b. Psychopharmacological treatment
Patients with severe depression receive:
Step IV: Combined psychotherapy and psychopharmacological treatment, optionally in inpatient setting.
arm group label: Control group: treatment as usual
arm group type: Active Comparator
description: Patients in the control group are screened by their general physician using the PHQ-D-9 depression scale. Patients included in the study then receive treatment as usual from general physician or other health service providers.
intervention type: Behavioral
intervention name: Active monitoring
description: General physician performs monitoring every 2 weeks using the PHQ-9 depression scale.
arm group label: Stepped care intervention (SCM)
intervention type: Behavioral
intervention name: Bibliotherapy
description: Patient works with self-help book "Selbsthilfe bei Depressionen" (Görlitz, 2010) under general physician's supervision.
arm group label: Stepped care intervention (SCM)
intervention type: Behavioral
intervention name: Online self-help
description: Patient works with online self-help program "Deprexis" under general physician's supervision.
arm group label: Stepped care intervention (SCM)
intervention type: Behavioral
intervention name: Outpatient psychotherapy
description: Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network.
arm group label: Stepped care intervention (SCM)
intervention type: Procedure
intervention name: Psychiatric treatment
description: Patient receives treatment from psychiatrist or general physician participating in the network, this includes psychopharmacotherapy. Treatment takes place within routine care, thus psychiatrists or general physicians individually determine the type of medication and are committed to follow the recommendations of the German S3-Guideline/National Disease Management Guideline for Unipolar Depression.
arm group label: Stepped care intervention (SCM)
intervention type: Behavioral
intervention name: Combined psychotherapy and psychopharmacological treatment
description: Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.
arm group label: Stepped care intervention (SCM)
intervention type: Other
intervention name: Control group: treatment as usual
description: treatment as usual
arm group label: Control group: treatment as usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Birgit Watzke, Prof. Dr.
role: Study Director
affiliation: Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany
last name: Martin Härter, Prof. Dr. Dr.
role: Study Director
affiliation: Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany
facility: 
country: Germany
url: http://www.psychenet.de/ueber-psychenet/teilprojekte/depression.html
description: Project homepage
responsible party type: Principal Investigator
investigator affiliation: Universitätsklinikum Hamburg-Eppendorf
investigator full name: PD Dr. phil. Birgit Watzke
investigator title: Principal Investigator
mesh term: Depression
mesh term: Depressive Disorder