<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/NCT02196896</url>
  </required_header>
  <id_info>
    <org_study_id>RK-97880</org_study_id>
    <nct_id>NCT02196896</nct_id>
  </id_info>
  <brief_title>Enhancing Inpatient Psychotherapeutic Treatment With Online Self-help : Acceptance and Efficacy</brief_title>
  <official_title>Enhancing Inpatient Psychotherapeutic Treatment With Online Self Help in a Randomised Controlled Trial: Acceptance and Efficacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rhön-Klinikum AG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johannes Gutenberg University Mainz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the acceptance and efficacy of the online self-help&#xD;
      program deprexis® for depressed patients in reducing the clinical symptoms of their&#xD;
      depression. The patients of the experimental group use deprexis® for 90 days, the patients of&#xD;
      the placebo group receive weekly online information about depression for 90 days as well.&#xD;
      Both groups receive their treatment in addition to their regular inpatient psychosomatic&#xD;
      treatment and as an aftercare intervention.The investigators hypothesize that the online&#xD;
      self-help group achieves a greater reduction of depression compared to the control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of depression measured with the &quot;Beck's Depression Inventory&quot; (BDI-II)</measure>
    <time_frame>Three months after randomization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of depression measured with the depression scale of the &quot;Patient Health Questionnaire&quot; (PHQ-9)</measure>
    <time_frame>Randomization, end of inpatient treatment (average 6 weeks), six months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of depression measured with the &quot;Beck's Depression Inventory&quot; (BDI-II)</measure>
    <time_frame>Randomization, end of inpatient treatment (average 6 weeks), six months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of anxiety measured with the &quot;Generalized Anxiety Disorder Scale&quot; (GAD-7)</measure>
    <time_frame>Randomization, end of inpatient treatment (average 6 weeks), six months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of dysfunctional depression related cognitions measured with the &quot;Dysfunctional Attitude Scale&quot; (DAS)</measure>
    <time_frame>Randomization, end of inpatient treatment (average 6 weeks), six months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved self-esteem measured with the &quot;Rosenberg Self-Esteem Scale&quot; (RSE)</measure>
    <time_frame>Randomization, end of inpatient treatment (average 6 weeks), six months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved quality of life measured with the &quot;European Health Interview Survey Quality of Life-8&quot; (EUROHIS-QOL 8)</measure>
    <time_frame>Randomization, end of inpatient treatment (average 6 weeks), six months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved working ability measured with the short form of the &quot;Work Ability Index&quot; (WAI)</measure>
    <time_frame>Randomization, end of inpatient treatment (average 6 weeks), six months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance and utilization of deprexis® measured with a self devised questionnaire</measure>
    <time_frame>End of inpatient treatment (average 6 weeks), three months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance and utilization of the information used in the placebo condition measured with a self devised questionnaire</measure>
    <time_frame>End of inpatient treatment (average 6 weeks), three months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of childhood traumas measured with the &quot;Childhood Trauma Questionnaire&quot; (CTQ)</measure>
    <time_frame>Randomization</time_frame>
    <description>Assumption that childhood traumas, assessed at the beginning of treatment, have a moderating effect on the reduction in the primary outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of structural deficits measured with the short form of the OPD-Structure Questionnaire (OPD-SFK)</measure>
    <time_frame>Randomization</time_frame>
    <description>Assumption that structural deficits, as assessed with the OPD-SFK questionnaire at the beginning of treatment have a moderating effect on the reduction in the primary outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic alliance between participant and inpatient psychotherapist measured with the &quot;Helping Alliance Questionnaire&quot; (HAQ).</measure>
    <time_frame>Randomization, end of inpatient treatment (average 6 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Course of mood, depressiveness and utilization of units</measure>
    <time_frame>During inpatient treatment (average 6 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utilization of other treatments after the end of inpatient treatment</measure>
    <time_frame>Six months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with inpatient treatment</measure>
    <time_frame>End of inpatient treatment (average 6 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Willingness to pay</measure>
    <time_frame>Three months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission from depression</measure>
    <time_frame>End of inpatient treatment (average 6 weeks), three months after randomization, six months after randomization</time_frame>
    <description>BDI score below the cutoff of 13 and a reliable change regarding Reliable Change Index (RCI)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">229</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>deprexis®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm use deprexis® as an additional treatment during their inpatient stay and as an aftercare intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Information</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in this arm receive online information about depression as a placebo comparator in addition to their treatment during their inpatient stay and as an aftercare intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>deprexis®</intervention_name>
    <description>Online self-help program in addition to inpatient psychosomatic treatment for 90 days.</description>
    <arm_group_label>deprexis®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Information</intervention_name>
    <description>The patients receive online information about depression once a week for 90 days.</description>
    <arm_group_label>Information</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inpatient treatment&#xD;
&#xD;
          -  Private internet access&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Age between 18 and 65 years&#xD;
&#xD;
          -  Knowledge of the German language&#xD;
&#xD;
          -  Score in the BDI-II &gt; 13 and clinical diagnosis of a depression (ICD-10: F32.x, F33.x,&#xD;
             F34.1, F43.2) verified by the inpatient therapist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychosis&#xD;
&#xD;
          -  Current alcohol or drug dependency&#xD;
&#xD;
          -  Borderline, antisocial, schizoid or schizotypal personality disorder&#xD;
&#xD;
          -  Anorexia nervosa&#xD;
&#xD;
          -  Life time diagnosis of a schizophrenia, schizoaffective , bipolar oder organic psychic&#xD;
             disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manfred E Beutel, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Psychosomatic Clinic Bad Neustadt</name>
      <address>
        <city>Bad Neustadt</city>
        <state>Bavaria</state>
        <zip>97616</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University</name>
      <address>
        <city>Mainz</city>
        <state>Rhineland-Palatinate</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>March 16, 2017</last_update_submitted>
  <last_update_submitted_qc>March 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation>
    <investigator_full_name>M.E. Beutel</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT02196896
org study id: RK-97880
nct id: NCT02196896
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the acceptance and efficacy of the online self-help
      program deprexis® for depressed patients in reducing the clinical symptoms of their
      depression. The patients of the experimental group use deprexis® for 90 days, the patients of
      the placebo group receive weekly online information about depression for 90 days as well.
      Both groups receive their treatment in addition to their regular inpatient psychosomatic
      treatment and as an aftercare intervention.The investigators hypothesize that the online
      self-help group achieves a greater reduction of depression compared to the control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II)
time frame: Three months after randomization
measure: Reduction of depression measured with the depression scale of the "Patient Health Questionnaire" (PHQ-9)
time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II)
time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Reduction of anxiety measured with the "Generalized Anxiety Disorder Scale" (GAD-7)
time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Reduction of dysfunctional depression related cognitions measured with the "Dysfunctional Attitude Scale" (DAS)
time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Improved self-esteem measured with the "Rosenberg Self-Esteem Scale" (RSE)
time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Improved quality of life measured with the "European Health Interview Survey Quality of Life-8" (EUROHIS-QOL 8)
time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Improved working ability measured with the short form of the "Work Ability Index" (WAI)
time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization
measure: Acceptance and utilization of deprexis® measured with a self devised questionnaire
time frame: End of inpatient treatment (average 6 weeks), three months after randomization
measure: Acceptance and utilization of the information used in the placebo condition measured with a self devised questionnaire
time frame: End of inpatient treatment (average 6 weeks), three months after randomization
measure: Degree of childhood traumas measured with the "Childhood Trauma Questionnaire" (CTQ)
time frame: Randomization
description: Assumption that childhood traumas, assessed at the beginning of treatment, have a moderating effect on the reduction in the primary outcome measure.
measure: Degree of structural deficits measured with the short form of the OPD-Structure Questionnaire (OPD-SFK)
time frame: Randomization
description: Assumption that structural deficits, as assessed with the OPD-SFK questionnaire at the beginning of treatment have a moderating effect on the reduction in the primary outcome measure.
measure: Therapeutic alliance between participant and inpatient psychotherapist measured with the "Helping Alliance Questionnaire" (HAQ).
time frame: Randomization, end of inpatient treatment (average 6 weeks)
measure: Course of mood, depressiveness and utilization of units
time frame: During inpatient treatment (average 6 weeks)
measure: Utilization of other treatments after the end of inpatient treatment
time frame: Six months after randomization
measure: Satisfaction with inpatient treatment
time frame: End of inpatient treatment (average 6 weeks)
measure: Willingness to pay
time frame: Three months after randomization
measure: Remission from depression
time frame: End of inpatient treatment (average 6 weeks), three months after randomization, six months after randomization
description: BDI score below the cutoff of 13 and a reliable change regarding Reliable Change Index (RCI)
arm group label: deprexis®
arm group type: Experimental
description: Patients in this arm use deprexis® as an additional treatment during their inpatient stay and as an aftercare intervention.
arm group label: Information
arm group type: Placebo Comparator
description: Patients in this arm receive online information about depression as a placebo comparator in addition to their treatment during their inpatient stay and as an aftercare intervention.
intervention type: Other
intervention name: deprexis®
description: Online self-help program in addition to inpatient psychosomatic treatment for 90 days.
arm group label: deprexis®
intervention type: Other
intervention name: Information
description: The patients receive online information about depression once a week for 90 days.
arm group label: Information
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Manfred E Beutel, Prof. Dr.
role: Principal Investigator
affiliation: University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Johannes Gutenberg University Mainz
investigator full name: M.E. Beutel
investigator title: Prof. Dr.
mesh term: Depression
sharing ipd: No