<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/NCT04428450</url>
  </required_header>
  <id_info>
    <org_study_id>Berger_2011_deprexis</org_study_id>
    <nct_id>NCT04428450</nct_id>
  </id_info>
  <brief_title>Internet-Based Treatment of Depression: Comparing Guided With Unguided Self-Help</brief_title>
  <official_title>Internet-Based Treatment of Depression: A Randomized Controlled Trial Comparing Guided With Unguided Self-Help</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gaia AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gaia AG</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>
      The study is a randomized controlled trial and to compare the benefits of a 10-week web-based&#xD;
      unguided self-help treatment with the same intervention complemented with weekly therapist&#xD;
      support via e-mail. A waiting-list control group will be included. The Beck Depression&#xD;
      Inventory (BDI-II) will be used as the primary outcome measure. Secondary outcomes include&#xD;
      general psychopathology, interpersonal problems, and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression is a major health problem associated with significant disability and economic&#xD;
      costs. Although depression can be treated effectively with several psychological and&#xD;
      pharmacological treatment options, many sufferers still seek or receive inadequate therapy or&#xD;
      no therapy at all. Internet-based treatments may help to serve this demand, being accessible&#xD;
      anytime and anywhere making it easier for underserved populations and people living in remote&#xD;
      areas to receive treatment. The present study aims to assess the efficacy of an&#xD;
      internet-based CBT intervention for depression (Deprexis), directly comparing the benefits of&#xD;
      a low intensity therapist-guided with an unguided self-help version. A waiting-list control&#xD;
      group will be included. Individuals meeting the diagnostic criteria of major depression or&#xD;
      dysthymia will be randomly assigned to one of the three conditions. While unguided self-help&#xD;
      will not include any contact with a therapist or the study team during the treatment, guided&#xD;
      self-help will include a weekly scheduled e-mail feedback by a therapist and the possibility&#xD;
      to ask questions via e-mail. While in an earlier study Deprexis was assessed as an add-on to&#xD;
      TAU, this study will examine the efficacy of the program when delivered as a stand-alone&#xD;
      intervention (i.e., only individuals who currently do not receive psychotherapy will be&#xD;
      included). Moreover, this study will include a structured diagnostic interview at&#xD;
      pretreatment. Only participants fulfilling the criteria of a depressive disorder (major&#xD;
      depression or dysthymia) will be included in the trial. Participants will be recruited in&#xD;
      Switzerland and Germany via articles in national and regional newspapers and a national&#xD;
      television interview. All questionnaires will be administered via the internet. The 21-item&#xD;
      BDI-II will be used as the main outcome measure. Secondary outcome measures will include the&#xD;
      Brief Symptom Inventory (53-item BSI), the Inventory of Interpersonal Problems (64-item IIP),&#xD;
      and the WHOQOL-BREF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2009</start_date>
  <completion_date type="Actual">December 31, 2010</completion_date>
  <primary_completion_date type="Actual">December 31, 2010</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>Beck Depression Inventory - II (BDI-II)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Self-report questionnaire, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brief Symptom Inventory (53-item BSI)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Psychopathology severity self-report measure; minimum value = 0, maximum value = 4 (higher scores indicate more severe psychopathology).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inventory of Interpersonal Problems (IIP)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Self-report measure of interpersonal problems; total score computed as the mean across all items; minimum value = 0, maximum value = 4 (higher scores indicate more severe psychopathology)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHOQOL-BREF</measure>
    <time_frame>10 weeks</time_frame>
    <description>Self-report quality of life measure; scores can range from 0 to 100, with higher scores indicating better quality of life.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>CSQ-8 (Client Satisfaction Questionnaire)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Self-report measure of global client satisfaction; scores can range from 1 to 4, with higher scores indicating greater satisfaction.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Deprexis (unguided)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>web-based self-help program without any support from a therapist during the 10-week treatment period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deprexis (guided, with therapist)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>web-based self-help program plus scheduled e-mail contact with a therapist during the 10-week treatment period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Wait-list group (subjects receive access to Deprexis after 10 weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deprexis</intervention_name>
    <description>CBT-based, integrative online self-help program</description>
    <arm_group_label>Deprexis (guided, with therapist)</arm_group_label>
    <arm_group_label>Deprexis (unguided)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  access to the internet&#xD;
&#xD;
          -  informed consent to participate&#xD;
&#xD;
          -  BDI-II score &gt; 13&#xD;
&#xD;
          -  if prescribed, constant dosage of medication (depression/anxiety) for 1 month prior&#xD;
             and during study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suicide item of BDI ≥ 2&#xD;
&#xD;
          -  other psychological treatment during this study&#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>Thomas Berger, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bern</affiliation>
  </overall_official>
  <results_reference>
    <citation>Berger T, Hammerli K, Gubser N, Andersson G, Caspar F. Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther. 2011;40(4):251-66. doi: 10.1080/16506073.2011.616531.</citation>
    <PMID>22060248</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Contact the PI for requests to use data.</ipd_description>
  </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/NCT04428450
org study id: Berger_2011_deprexis
nct id: NCT04428450
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is a randomized controlled trial and to compare the benefits of a 10-week web-based
      unguided self-help treatment with the same intervention complemented with weekly therapist
      support via e-mail. A waiting-list control group will be included. The Beck Depression
      Inventory (BDI-II) will be used as the primary outcome measure. Secondary outcomes include
      general psychopathology, interpersonal problems, and quality of life.
Depression is a major health problem associated with significant disability and economic
      costs. Although depression can be treated effectively with several psychological and
      pharmacological treatment options, many sufferers still seek or receive inadequate therapy or
      no therapy at all. Internet-based treatments may help to serve this demand, being accessible
      anytime and anywhere making it easier for underserved populations and people living in remote
      areas to receive treatment. The present study aims to assess the efficacy of an
      internet-based CBT intervention for depression (Deprexis), directly comparing the benefits of
      a low intensity therapist-guided with an unguided self-help version. A waiting-list control
      group will be included. Individuals meeting the diagnostic criteria of major depression or
      dysthymia will be randomly assigned to one of the three conditions. While unguided self-help
      will not include any contact with a therapist or the study team during the treatment, guided
      self-help will include a weekly scheduled e-mail feedback by a therapist and the possibility
      to ask questions via e-mail. While in an earlier study Deprexis was assessed as an add-on to
      TAU, this study will examine the efficacy of the program when delivered as a stand-alone
      intervention (i.e., only individuals who currently do not receive psychotherapy will be
      included). Moreover, this study will include a structured diagnostic interview at
      pretreatment. Only participants fulfilling the criteria of a depressive disorder (major
      depression or dysthymia) will be included in the trial. Participants will be recruited in
      Switzerland and Germany via articles in national and regional newspapers and a national
      television interview. All questionnaires will be administered via the internet. The 21-item
      BDI-II will be used as the main outcome measure. Secondary outcome measures will include the
      Brief Symptom Inventory (53-item BSI), the Inventory of Interpersonal Problems (64-item IIP),
      and the WHOQOL-BREF.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Beck Depression Inventory - II (BDI-II)
time frame: 10 weeks
description: Self-report questionnaire, depression symptom severity, scores can range from 0 to 63, with higher scores indicating more severe depression.
measure: Brief Symptom Inventory (53-item BSI)
time frame: 10 weeks
description: Psychopathology severity self-report measure; minimum value = 0, maximum value = 4 (higher scores indicate more severe psychopathology).
measure: Inventory of Interpersonal Problems (IIP)
time frame: 10 weeks
description: Self-report measure of interpersonal problems; total score computed as the mean across all items; minimum value = 0, maximum value = 4 (higher scores indicate more severe psychopathology)
measure: WHOQOL-BREF
time frame: 10 weeks
description: Self-report quality of life measure; scores can range from 0 to 100, with higher scores indicating better quality of life.
measure: CSQ-8 (Client Satisfaction Questionnaire)
time frame: 10 weeks
description: Self-report measure of global client satisfaction; scores can range from 1 to 4, with higher scores indicating greater satisfaction.
arm group label: Deprexis (unguided)
arm group type: Experimental
description: web-based self-help program without any support from a therapist during the 10-week treatment period
arm group label: Deprexis (guided, with therapist)
arm group type: Experimental
description: web-based self-help program plus scheduled e-mail contact with a therapist during the 10-week treatment period
arm group label: Wait-list
arm group type: No Intervention
description: Wait-list group (subjects receive access to Deprexis after 10 weeks)
intervention type: Device
intervention name: Deprexis
description: CBT-based, integrative online self-help program
arm group label: Deprexis (guided, with therapist)
arm group label: Deprexis (unguided)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Berger, Ph.D.
role: Principal Investigator
affiliation: University of Bern
citation: Berger T, Hammerli K, Gubser N, Andersson G, Caspar F. Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther. 2011;40(4):251-66. doi: 10.1080/16506073.2011.616531.
PMID: 22060248
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No
ipd description: Contact the PI for requests to use data.