<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/NCT04460378</url>
  </required_header>
  <id_info>
    <org_study_id>ChariteAmb</org_study_id>
    <nct_id>NCT04460378</nct_id>
  </id_info>
  <brief_title>Exposure Initializes Therapy - Treatment Of Homebound Patients Extended</brief_title>
  <acronym>ExITTOHoPE</acronym>
  <official_title>Exposure Initializes Therapy - Treatment Of Homebound Patients Extended</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Humboldt-Universität zu Berlin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stiftung Deutsche Klassenlotterie Berlin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</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>
      Cognitive behavioral treatment of homebound patients with severe agoraphobia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Homebound patients with severe agoraphobia are treated with an exposure focussed cognitive&#xD;
      behavioral therapy. The treatment begins at home. With a quick onset of guided exposure,&#xD;
      patients get the possibility to develope the capability to reach the regular Treatment&#xD;
      Location on their own very rapidly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>repeated measure of a single group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MI</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>Mobility Inventory</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AKF</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>Angst-Kontroll-Fragebogen (anxiety control)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ASI</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>Angstsensitivität (anxiety sensitivity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NEO-FFI</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>Persönlichkeitsfragebogen (personality inventory)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSQ 20</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>perceived stress questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rs 13</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>Resilienzskala (resilience scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SWE</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>Selbstwirksamkeitsfragebogen (self-efficacy questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UI18</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>Unsicherheitsintoleranz Fragebogen (intolerance of uncertainty questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>life quality questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AAQ II</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>Acceptance and Action questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACQ</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>Agoraphobic cognition questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BSQ</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>Bosy Sensation Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDI II</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>Beck Depression inventory II</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>alpha-amylase</measure>
    <time_frame>change from baseline to follow up (+98 days)</time_frame>
    <description>daily profile of salivary alpha amylase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cortisol</measure>
    <time_frame>change from baseline to follow up (+98 days)</time_frame>
    <description>daily profile of salivary cortisol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PAS</measure>
    <time_frame>Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)</time_frame>
    <description>Panik- und Agoraphobie-Skala (Panic and agoraphobia scale)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Agoraphobia</condition>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Manualized Cognitive Behavioral Therapy starting at the patients' home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cognitive behavioral therapy</intervention_name>
    <description>cognitive behavioral therapy with Focus on guided exposure</description>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  agoraphobia with/without Panic disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychotic disorders&#xD;
&#xD;
          -  bipolar disorders&#xD;
&#xD;
          -  acute substance dependency&#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>Jens Plag, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jens Plag, Dr.</last_name>
    <phone>+49 30 450 510 306</phone>
    <email>jens.plag@charite.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carolin Liebscher, Dr.</last_name>
    <phone>+49 30 450 517 017</phone>
    <email>carolin.liebscher@charite.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jens Plag, Dr.</last_name>
      <phone>0049 30 450 517306</phone>
      <email>jens.plag@charite.de</email>
    </contact>
    <contact_backup>
      <last_name>Carolin Liebscher, Dr.</last_name>
      <phone>0049 30 450 517017</phone>
      <email>carolin.liebscher@charite.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>March 22, 2018</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Dr. Jens Plag</investigator_full_name>
    <investigator_title>Dr. med. Jens Plag</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agoraphobia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04460378
org study id: ChariteAmb
nct id: NCT04460378
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cognitive behavioral treatment of homebound patients with severe agoraphobia.
Homebound patients with severe agoraphobia are treated with an exposure focussed cognitive
      behavioral therapy. The treatment begins at home. With a quick onset of guided exposure,
      patients get the possibility to develope the capability to reach the regular Treatment
      Location on their own very rapidly.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: repeated measure of a single group
primary purpose: Treatment
masking: None (Open Label)
measure: MI
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: Mobility Inventory
measure: AKF
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: Angst-Kontroll-Fragebogen (anxiety control)
measure: ASI
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: Angstsensitivität (anxiety sensitivity)
measure: NEO-FFI
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: Persönlichkeitsfragebogen (personality inventory)
measure: PSQ 20
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: perceived stress questionnaire
measure: rs 13
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: Resilienzskala (resilience scale)
measure: SWE
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: Selbstwirksamkeitsfragebogen (self-efficacy questionnaire)
measure: UI18
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: Unsicherheitsintoleranz Fragebogen (intolerance of uncertainty questionnaire)
measure: EQ-5D
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: life quality questionnaire
measure: AAQ II
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: Acceptance and Action questionnaire
measure: ACQ
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: Agoraphobic cognition questionnaire
measure: BSQ
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: Bosy Sensation Questionnaire
measure: BDI II
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: Beck Depression inventory II
measure: alpha-amylase
time frame: change from baseline to follow up (+98 days)
description: daily profile of salivary alpha amylase
measure: cortisol
time frame: change from baseline to follow up (+98 days)
description: daily profile of salivary cortisol
measure: PAS
time frame: Change from baseline to 4th psychotherapy session (+42 days) and change from baseline to the 9th psychotherapy session (+60 days) and change from baseline to follow up (+98 days)
description: Panik- und Agoraphobie-Skala (Panic and agoraphobia scale)
arm group label: Cognitive Behavioral Therapy
arm group type: Experimental
description: Manualized Cognitive Behavioral Therapy starting at the patients' home.
intervention type: Behavioral
intervention name: cognitive behavioral therapy
description: cognitive behavioral therapy with Focus on guided exposure
arm group label: Cognitive Behavioral Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jens Plag, MD
role: Study Chair
affiliation: Charite University, Berlin, Germany
last name: Jens Plag, Dr.
phone: +49 30 450 510 306
email: jens.plag@charite.de
last name: Carolin Liebscher, Dr.
phone: +49 30 450 517 017
email: carolin.liebscher@charite.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Dr. Jens Plag
investigator title: Dr. med. Jens Plag
mesh term: Agoraphobia
sharing ipd: Undecided