<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/NCT01663649</url>
  </required_header>
  <id_info>
    <org_study_id>Deprexis_2</org_study_id>
    <nct_id>NCT01663649</nct_id>
  </id_info>
  <brief_title>Effectiveness of Web-based Treatment for Depression in Patients With Neurologic Disorders</brief_title>
  <official_title>Evaluation of the Effectiveness of a Web-based Treatment Program for Depression (Deprexis) for the Reduction of Depressive Symptoms in Patients With Multiple Sclerosis and Epilepsy. A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Epilepsy Centre Alsterdorf</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      200 persons (100 with multiple sclerosis and 100 with epilepsy) with depressive symptoms are&#xD;
      recruited via the multiple sclerosis clinics of the University Medical Center&#xD;
      Hamburg-Eppendorf and the epilepsy centre Alsterdorf and randomly assigned either to the&#xD;
      online program deprexis or to a wait-list control condition. All participants receive&#xD;
      free-of-charge online access to deprexis either immediately or with a six month delay.&#xD;
&#xD;
      At three time points (1. prior to intervention, 2. after completion of the intervention nine&#xD;
      weeks later and 3. at follow-up six month later), both groups are assessed via an anonymous&#xD;
      online survey, which was implemented using the software package OPST®.&#xD;
&#xD;
      The survey consists of different questionnaires. The Beck Depression Inventory (BDI)&#xD;
      represents the primary outcome (IIT analysis for pre versus post). It is assumed that the&#xD;
      severity of depressive symptoms will improve to a significantly greater extent in the&#xD;
      deprexis than in the wait-list control condition in the course of nine weeks and will be&#xD;
      maintained in a six month follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Deprexis is a web-based intervention that can be obtained online (www.deprexis.com). Deprexis&#xD;
      encompasses 10 content modules with a strong focus on evidence-based cognitive-behavioral&#xD;
      techniques, either from its so-called first (behavior-oriented), second (cognitive-oriented)&#xD;
      or third wave (e.g. mindfulness and acceptance): (1) psychoeducation, (2) behavioral&#xD;
      activation, (3) cognitive modification, (4) mindfulness and acceptance, (5) interpersonal&#xD;
      skills, (6) relaxation, physical exercise and lifestyle modification, (7) problem solving and&#xD;
      (8) expressive writing and forgiveness, (9) positive psychology and (10) dreamwork and&#xD;
      emotion-focus interventions. The ten modules are framed by one introductory and one summary&#xD;
      module. Communication is carried out online via simulated dialogues. Patients have to respond&#xD;
      to narrative text messages from the virtual therapists in multiple-choice response fashion,&#xD;
      enabling them to express doubt, to affirm a particular message or to request more&#xD;
      information. Text messages are aided with drawings, photographs and animations. The program&#xD;
      is adaptive and selects exercises and contents on the basis of the subject's response. The&#xD;
      modules are sequential and each module refers and builds upon previous one. Modules can (and&#xD;
      should be) repeated within the intervention period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Severity of depressive symptoms</measure>
    <time_frame>7 Days</time_frame>
    <description>Severity of depressive symptoms as assessed with the Beck Depression Inventory (BDI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>14 days</time_frame>
    <description>quality of life as assessed by the WHO Quality of Life scale (WHO-QOL BREF)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>depressive symptoms</measure>
    <time_frame>7 days</time_frame>
    <description>depressive symptoms as assessed by the Quick Inventory of Depressive Symptomatology (QIDS)</description>
  </other_outcome>
  <other_outcome>
    <measure>core self-evaluations</measure>
    <time_frame>7 days</time_frame>
    <description>core self-evaluations as assessed by the Core Self-Evaluations Scale (CSES)</description>
  </other_outcome>
  <other_outcome>
    <measure>suicidal behaviors and tendencies</measure>
    <time_frame>7 days</time_frame>
    <description>suicidal behaviors and tendencies as assessed by the Suicidal Behaviors Questionnaire-Revised (SBQ-R)</description>
  </other_outcome>
  <other_outcome>
    <measure>quality of life</measure>
    <time_frame>7 days</time_frame>
    <description>quality of life as assessed by the Hamburg MS Quality of Life Questionnaire (HALEMS)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Deprexis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deprexis (Web-based intervention deprexis consists of ten online modules (plus one introductory and one summary module) representing different psychotherapeutic strategies with a strong focus on evidence-based cognitive-behavioral techniques (e.g. interpersonal skills). Each module lasts approximately 10-60 minutes (e.g. depending on the user´s reading speed). Modules are sequential and organized as simulated dialogues. Each module refers and builds upon previous one. The program is delivered at no cost to participants.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wait-list group (Subjects receive access to deprexis after six months)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Deprexis</intervention_name>
    <description>web-based treatment program for depression</description>
    <arm_group_label>Deprexis</arm_group_label>
    <arm_group_label>Wait-list</arm_group_label>
    <other_name>web-based treatment program for depression</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wait-list</intervention_name>
    <description>the wait-list group receives Deprexis after 6 month</description>
    <arm_group_label>Wait-list</arm_group_label>
    <other_name>web-based treatment for depression after 6 month</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of a confirmed diagnosis of multiple sclerosis or epilepsy&#xD;
&#xD;
          -  self-reported urge to be treated for depressive symptoms (no externally confirmed&#xD;
             diagnosis necessary)&#xD;
&#xD;
          -  informed consent (provided online in line with regulations by the Hamburg Department&#xD;
             of Data Security)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to provide informed consent&#xD;
&#xD;
          -  diagnosis of bipolar or schizophrenia spectrum disorders&#xD;
&#xD;
          -  substantial neurocognitive impairment (e.g. dementia)&#xD;
&#xD;
          -  acute suicidal tendencies as assessed with the Suicide Behaviors Questionnaire-Revised&#xD;
             (SBQ-R). Subjects excluded for this reason are provided various emergency contacts and&#xD;
             phone numbers.&#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>Steffen Moritz, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center Hamburg-Eppendorf - Neurology</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epilepsy Centre Alsterdorf</name>
      <address>
        <city>Hamburg</city>
        <zip>22337</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Moritz S, Schilling L, Hauschildt M, Schroder J, Treszl A. A randomized controlled trial of internet-based therapy in depression. Behav Res Ther. 2012 Aug;50(7-8):513-21. doi: 10.1016/j.brat.2012.04.006. Epub 2012 May 3.</citation>
    <PMID>22677231</PMID>
  </reference>
  <reference>
    <citation>Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M. Effectiveness of a novel integrative online treatment for depression (Deprexis): randomized controlled trial. J Med Internet Res. 2009 May 11;11(2):e15. doi: 10.2196/jmir.1151.</citation>
    <PMID>19632969</PMID>
  </reference>
  <results_reference>
    <citation>Fischer A, Schroder J, Vettorazzi E, Wolf OT, Pottgen J, Lau S, Heesen C, Moritz S, Gold SM. An online programme to reduce depression in patients with multiple sclerosis: a randomised controlled trial. Lancet Psychiatry. 2015 Mar;2(3):217-23. doi: 10.1016/S2215-0366(14)00049-2. Epub 2015 Feb 25.</citation>
    <PMID>26359900</PMID>
  </results_reference>
  <results_reference>
    <citation>Schroder J, Bruckner K, Fischer A, Lindenau M, Kother U, Vettorazzi E, Moritz S. Efficacy of a psychological online intervention for depression in people with epilepsy: a randomized controlled trial. Epilepsia. 2014 Dec;55(12):2069-76. doi: 10.1111/epi.12833. Epub 2014 Nov 19.</citation>
    <PMID>25410633</PMID>
  </results_reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>March 24, 2015</last_update_submitted>
  <last_update_submitted_qc>March 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Online-Therapy</keyword>
  <keyword>Deprexis</keyword>
  <keyword>Self-help</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/NCT01663649
org study id: Deprexis_2
nct id: NCT01663649
lead sponsor: 
collaborator: 
has dmc: No
200 persons (100 with multiple sclerosis and 100 with epilepsy) with depressive symptoms are
      recruited via the multiple sclerosis clinics of the University Medical Center
      Hamburg-Eppendorf and the epilepsy centre Alsterdorf and randomly assigned either to the
      online program deprexis or to a wait-list control condition. All participants receive
      free-of-charge online access to deprexis either immediately or with a six month delay.

      At three time points (1. prior to intervention, 2. after completion of the intervention nine
      weeks later and 3. at follow-up six month later), both groups are assessed via an anonymous
      online survey, which was implemented using the software package OPST®.

      The survey consists of different questionnaires. The Beck Depression Inventory (BDI)
      represents the primary outcome (IIT analysis for pre versus post). It is assumed that the
      severity of depressive symptoms will improve to a significantly greater extent in the
      deprexis than in the wait-list control condition in the course of nine weeks and will be
      maintained in a six month follow-up.
Deprexis is a web-based intervention that can be obtained online (www.deprexis.com). Deprexis
      encompasses 10 content modules with a strong focus on evidence-based cognitive-behavioral
      techniques, either from its so-called first (behavior-oriented), second (cognitive-oriented)
      or third wave (e.g. mindfulness and acceptance): (1) psychoeducation, (2) behavioral
      activation, (3) cognitive modification, (4) mindfulness and acceptance, (5) interpersonal
      skills, (6) relaxation, physical exercise and lifestyle modification, (7) problem solving and
      (8) expressive writing and forgiveness, (9) positive psychology and (10) dreamwork and
      emotion-focus interventions. The ten modules are framed by one introductory and one summary
      module. Communication is carried out online via simulated dialogues. Patients have to respond
      to narrative text messages from the virtual therapists in multiple-choice response fashion,
      enabling them to express doubt, to affirm a particular message or to request more
      information. Text messages are aided with drawings, photographs and animations. The program
      is adaptive and selects exercises and contents on the basis of the subject's response. The
      modules are sequential and each module refers and builds upon previous one. Modules can (and
      should be) repeated within the intervention period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Severity of depressive symptoms
time frame: 7 Days
description: Severity of depressive symptoms as assessed with the Beck Depression Inventory (BDI)
measure: quality of life
time frame: 14 days
description: quality of life as assessed by the WHO Quality of Life scale (WHO-QOL BREF)
measure: depressive symptoms
time frame: 7 days
description: depressive symptoms as assessed by the Quick Inventory of Depressive Symptomatology (QIDS)
measure: core self-evaluations
time frame: 7 days
description: core self-evaluations as assessed by the Core Self-Evaluations Scale (CSES)
measure: suicidal behaviors and tendencies
time frame: 7 days
description: suicidal behaviors and tendencies as assessed by the Suicidal Behaviors Questionnaire-Revised (SBQ-R)
measure: quality of life
time frame: 7 days
description: quality of life as assessed by the Hamburg MS Quality of Life Questionnaire (HALEMS)
arm group label: Deprexis
arm group type: Experimental
description: Deprexis (Web-based intervention deprexis consists of ten online modules (plus one introductory and one summary module) representing different psychotherapeutic strategies with a strong focus on evidence-based cognitive-behavioral techniques (e.g. interpersonal skills). Each module lasts approximately 10-60 minutes (e.g. depending on the user´s reading speed). Modules are sequential and organized as simulated dialogues. Each module refers and builds upon previous one. The program is delivered at no cost to participants.)
arm group label: Wait-list
arm group type: Active Comparator
description: Wait-list group (Subjects receive access to deprexis after six months)
intervention type: Behavioral
intervention name: Deprexis
description: web-based treatment program for depression
arm group label: Deprexis
arm group label: Wait-list
other name: web-based treatment program for depression
intervention type: Behavioral
intervention name: Wait-list
description: the wait-list group receives Deprexis after 6 month
arm group label: Wait-list
other name: web-based treatment for depression after 6 month
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Steffen Moritz, Prof.
role: Principal Investigator
affiliation: Universitätsklinikum Hamburg-Eppendorf
facility: 
facility: 
country: Germany
citation: Moritz S, Schilling L, Hauschildt M, Schroder J, Treszl A. A randomized controlled trial of internet-based therapy in depression. Behav Res Ther. 2012 Aug;50(7-8):513-21. doi: 10.1016/j.brat.2012.04.006. Epub 2012 May 3.
PMID: 22677231
citation: Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M. Effectiveness of a novel integrative online treatment for depression (Deprexis): randomized controlled trial. J Med Internet Res. 2009 May 11;11(2):e15. doi: 10.2196/jmir.1151.
PMID: 19632969
citation: Fischer A, Schroder J, Vettorazzi E, Wolf OT, Pottgen J, Lau S, Heesen C, Moritz S, Gold SM. An online programme to reduce depression in patients with multiple sclerosis: a randomised controlled trial. Lancet Psychiatry. 2015 Mar;2(3):217-23. doi: 10.1016/S2215-0366(14)00049-2. Epub 2015 Feb 25.
PMID: 26359900
citation: Schroder J, Bruckner K, Fischer A, Lindenau M, Kother U, Vettorazzi E, Moritz S. Efficacy of a psychological online intervention for depression in people with epilepsy: a randomized controlled trial. Epilepsia. 2014 Dec;55(12):2069-76. doi: 10.1111/epi.12833. Epub 2014 Nov 19.
PMID: 25410633
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder