<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/NCT01680237</url>
  </required_header>
  <id_info>
    <org_study_id>BoSPmA</org_study_id>
    <nct_id>NCT01680237</nct_id>
  </id_info>
  <brief_title>Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia</brief_title>
  <official_title>Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruhr University of Bochum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruhr University of Bochum</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Panic disorder with agoraphobia is a prevalent and one of the most handicapping anxiety&#xD;
      disorders. Although the efficacy of psychological treatment for panic disorder with&#xD;
      agoraphobia has been the subject of a great deal of research, studies comparing&#xD;
      cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect&#xD;
      small to moderate differences. Therefore, the primary purpose of the present study is to&#xD;
      investigate if the combination of cognitive techniques with exposure in vivo is superior to&#xD;
      the effects of exposure alone for patients with moderate to severe agoraphobia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anxiety disorders are the most common group of mental illnesses, with lifetime prevalence&#xD;
      estimates ranging between 10-30% (Kessler et al 2007). They are an economic burden on society&#xD;
      and the sixth largest cause of disability globally (Baxter et al 2014; Fineberg et al 2013).&#xD;
      Suffering from an anxiety disorder is distressing, with affected individuals reporting&#xD;
      adverse effects on quality of life comparable to sufferers of major depressive disorder, and&#xD;
      in excess of the population norm (Mendlowicz and Stein 2000). Panic disorder with agoraphobia&#xD;
      is especially prevalent and one of the most handicapping anxiety disorders.&#xD;
&#xD;
      Although the efficacy of psychological treatment for panic disorder with agoraphobia has been&#xD;
      the subject of a great deal of research (Sanchez-Meca, Rosa-Alcazar, Marin-Martinez &amp;&#xD;
      Gomez-Conesa, 2010), studies comparing cognitive-behavioral therapy and exposure in vivo have&#xD;
      regularly been underpowered to detect small to moderate differences.&#xD;
&#xD;
      Therefore, the primary purpose of the present study is to investigate if the combination of&#xD;
      cognitive techniques with exposure in vivo is superior to the effects of exposure alone for&#xD;
      patients with moderate to severe agoraphobia. Participants suffering from panic disorder,&#xD;
      agoraphobia receive exposure-based treatment with elements of cognitive restructuring&#xD;
      (CBT-group) or without such elements (Exposure-only group) delivered according to treatment&#xD;
      manuals and in individual sessions with a maximum of 30 sessions á 50 minutes. Both&#xD;
      treatments cover psychoeducation on the nature of anxiety and panic, interoceptive and&#xD;
      intensified situational exposure exercises. In the CBT group identification and correction of&#xD;
      maladaptive thoughts about anxiety and its consequences is furthermore part of the treatment&#xD;
      package.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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 (from baseline) in the Mobility Inventory</measure>
    <time_frame>0, 6, 12 month after treatment</time_frame>
    <description>Avoidance Behaviour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) in a Behavioral Approach Test</measure>
    <time_frame>0, 6, 12 month after treatment</time_frame>
    <description>Participants are asked to go up a high and narrow church tower. The test yields number of floors (0-10) the patient achieves, recording the experienced anxiety level (0-100).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change (from baseline) in the Anxiety Disorder Interview Schedule</measure>
    <time_frame>0, 6, 12 month after treatment</time_frame>
    <description>Remission Status</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Panic Disorder With Agoraphobia</condition>
  <arm_group>
    <arm_group_label>Cognitive behavior therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Identification of bodily sensations, cognitions and safety behaviors characteristic of the individual patient&#xD;
Modification of dysfunctional beliefs and assumptions using socratic questioning and behavioral experiments&#xD;
Exposure in-vivo&#xD;
Relapse prevention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exposure in-vivo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preparation of a brief behavior analysis of the individual case and construction of a hierarchy of relevant (internal and external) phobic situations&#xD;
Exposure with internal stimuli&#xD;
Exposure with external stimuli&#xD;
Relapse prevention&#xD;
Remark: In this condition there is no active work with the patient's catastrophic cognitions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavior therapy</intervention_name>
    <description>Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises as well as identification and correction of maladaptive thoughts about anxiety and its consequences.</description>
    <arm_group_label>Cognitive behavior therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure in-vivo</intervention_name>
    <description>Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises.</description>
    <arm_group_label>Exposure in-vivo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of panic disorder with agoraphobia by trained clinician using a structured&#xD;
             interview&#xD;
&#xD;
          -  The anxiety disorder is considered to be the patient's main current problem&#xD;
&#xD;
          -  Age between 18 and 65 years&#xD;
&#xD;
          -  The patient has agreed to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Diagnosis of bipolar disorder, psychotic disorder, alcohol/substance abuse or dependency&#xD;
        (within past 3 months), prominent risk of self-harm, organic mental disorder; concurrent&#xD;
        psychotherapeutic or psychopharmacological treatment&#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>Tobias Teismann, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruhr-Universität Bochum</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tobias Teismann, Dr.</last_name>
    <phone>0049-234-3227787</phone>
    <email>tobias.teismann@rub.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Juergen Margraf, Prof. Dr.</last_name>
    <phone>0049-234-3223169</phone>
    <email>juergen.margraf@rub.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zentrum für Psychotherapie</name>
      <address>
        <city>Bochum</city>
        <state>NRW</state>
        <zip>44787</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tobias Teismann, Dr.</last_name>
      <phone>0049-234-3227787</phone>
      <email>tobias.teismann@rub.de</email>
    </contact>
    <investigator>
      <last_name>Tobias Teismann, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Sanchez-Meca J, Rosa-Alcazar AI, Marin-Martinez F, Gomez-Conesa A. Psychological treatment of panic disorder with or without agoraphobia: a meta-analysis. Clin Psychol Rev. 2010 Feb;30(1):37-50. doi: 10.1016/j.cpr.2009.08.011. Erratum In: Clin Psychol Rev. 2010 Aug;30(6):815-7.</citation>
    <PMID>19775792</PMID>
  </reference>
  <reference>
    <citation>Kessler RC, Angermeyer M, Anthony JC, DE Graaf R, Demyttenaere K, Gasquet I, DE Girolamo G, Gluzman S, Gureje O, Haro JM, Kawakami N, Karam A, Levinson D, Medina Mora ME, Oakley Browne MA, Posada-Villa J, Stein DJ, Adley Tsang CH, Aguilar-Gaxiola S, Alonso J, Lee S, Heeringa S, Pennell BE, Berglund P, Gruber MJ, Petukhova M, Chatterji S, Ustun TB. Lifetime prevalence and age-of-onset distributions of mental disorders in the World Health Organization's World Mental Health Survey Initiative. World Psychiatry. 2007 Oct;6(3):168-76.</citation>
    <PMID>18188442</PMID>
  </reference>
  <reference>
    <citation>Baxter AJ, Vos T, Scott KM, Ferrari AJ, Whiteford HA. The global burden of anxiety disorders in 2010. Psychol Med. 2014 Aug;44(11):2363-74. doi: 10.1017/S0033291713003243. Epub 2014 Jan 22.</citation>
    <PMID>24451993</PMID>
  </reference>
  <reference>
    <citation>Fineberg NA, Haddad PM, Carpenter L, Gannon B, Sharpe R, Young AH, Joyce E, Rowe J, Wellsted D, Nutt DJ, Sahakian BJ. The size, burden and cost of disorders of the brain in the UK. J Psychopharmacol. 2013 Sep;27(9):761-70. doi: 10.1177/0269881113495118. Epub 2013 Jul 24.</citation>
    <PMID>23884863</PMID>
  </reference>
  <reference>
    <citation>Mendlowicz MV, Stein MB. Quality of life in individuals with anxiety disorders. Am J Psychiatry. 2000 May;157(5):669-82. doi: 10.1176/appi.ajp.157.5.669.</citation>
    <PMID>10784456</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruhr University of Bochum</investigator_affiliation>
    <investigator_full_name>Dr. Tobias Teismann</investigator_full_name>
    <investigator_title>Dr. Tobias Teismann</investigator_title>
  </responsible_party>
  <keyword>cognitive behavior therapy</keyword>
  <keyword>exposure in-vivo</keyword>
  <keyword>panic disorder with agoraphobia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Panic Disorder</mesh_term>
    <mesh_term>Agoraphobia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be available upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Available upon request from August 2021</ipd_time_frame>
    <ipd_access_criteria>Researchers in the field of anxiety disorders, meta-analysis, contact: tobias Teismann</ipd_access_criteria>
  </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/NCT01680237
org study id: BoSPmA
nct id: NCT01680237
lead sponsor: 
has dmc: No
Panic disorder with agoraphobia is a prevalent and one of the most handicapping anxiety
      disorders. Although the efficacy of psychological treatment for panic disorder with
      agoraphobia has been the subject of a great deal of research, studies comparing
      cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect
      small to moderate differences. Therefore, the primary purpose of the present study is to
      investigate if the combination of cognitive techniques with exposure in vivo is superior to
      the effects of exposure alone for patients with moderate to severe agoraphobia.
Anxiety disorders are the most common group of mental illnesses, with lifetime prevalence
      estimates ranging between 10-30% (Kessler et al 2007). They are an economic burden on society
      and the sixth largest cause of disability globally (Baxter et al 2014; Fineberg et al 2013).
      Suffering from an anxiety disorder is distressing, with affected individuals reporting
      adverse effects on quality of life comparable to sufferers of major depressive disorder, and
      in excess of the population norm (Mendlowicz and Stein 2000). Panic disorder with agoraphobia
      is especially prevalent and one of the most handicapping anxiety disorders.

      Although the efficacy of psychological treatment for panic disorder with agoraphobia has been
      the subject of a great deal of research (Sanchez-Meca, Rosa-Alcazar, Marin-Martinez &
      Gomez-Conesa, 2010), studies comparing cognitive-behavioral therapy and exposure in vivo have
      regularly been underpowered to detect small to moderate differences.

      Therefore, the primary purpose of the present study is to investigate if the combination of
      cognitive techniques with exposure in vivo is superior to the effects of exposure alone for
      patients with moderate to severe agoraphobia. Participants suffering from panic disorder,
      agoraphobia receive exposure-based treatment with elements of cognitive restructuring
      (CBT-group) or without such elements (Exposure-only group) delivered according to treatment
      manuals and in individual sessions with a maximum of 30 sessions á 50 minutes. Both
      treatments cover psychoeducation on the nature of anxiety and panic, interoceptive and
      intensified situational exposure exercises. In the CBT group identification and correction of
      maladaptive thoughts about anxiety and its consequences is furthermore part of the treatment
      package.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change (from baseline) in the Mobility Inventory
time frame: 0, 6, 12 month after treatment
description: Avoidance Behaviour
measure: Change (from baseline) in a Behavioral Approach Test
time frame: 0, 6, 12 month after treatment
description: Participants are asked to go up a high and narrow church tower. The test yields number of floors (0-10) the patient achieves, recording the experienced anxiety level (0-100).
measure: Change (from baseline) in the Anxiety Disorder Interview Schedule
time frame: 0, 6, 12 month after treatment
description: Remission Status
arm group label: Cognitive behavior therapy
arm group type: Active Comparator
description: Identification of bodily sensations, cognitions and safety behaviors characteristic of the individual patient
Modification of dysfunctional beliefs and assumptions using socratic questioning and behavioral experiments
Exposure in-vivo
Relapse prevention
arm group label: Exposure in-vivo
arm group type: Active Comparator
description: Preparation of a brief behavior analysis of the individual case and construction of a hierarchy of relevant (internal and external) phobic situations
Exposure with internal stimuli
Exposure with external stimuli
Relapse prevention
Remark: In this condition there is no active work with the patient's catastrophic cognitions
intervention type: Behavioral
intervention name: Cognitive behavior therapy
description: Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises as well as identification and correction of maladaptive thoughts about anxiety and its consequences.
arm group label: Cognitive behavior therapy
intervention type: Behavioral
intervention name: Exposure in-vivo
description: Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises.
arm group label: Exposure in-vivo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Tobias Teismann, Dr.
role: Principal Investigator
affiliation: Ruhr-Universität Bochum
last name: Tobias Teismann, Dr.
phone: 0049-234-3227787
email: tobias.teismann@rub.de
last name: Juergen Margraf, Prof. Dr.
phone: 0049-234-3223169
email: juergen.margraf@rub.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
citation: Sanchez-Meca J, Rosa-Alcazar AI, Marin-Martinez F, Gomez-Conesa A. Psychological treatment of panic disorder with or without agoraphobia: a meta-analysis. Clin Psychol Rev. 2010 Feb;30(1):37-50. doi: 10.1016/j.cpr.2009.08.011. Erratum In: Clin Psychol Rev. 2010 Aug;30(6):815-7.
PMID: 19775792
citation: Kessler RC, Angermeyer M, Anthony JC, DE Graaf R, Demyttenaere K, Gasquet I, DE Girolamo G, Gluzman S, Gureje O, Haro JM, Kawakami N, Karam A, Levinson D, Medina Mora ME, Oakley Browne MA, Posada-Villa J, Stein DJ, Adley Tsang CH, Aguilar-Gaxiola S, Alonso J, Lee S, Heeringa S, Pennell BE, Berglund P, Gruber MJ, Petukhova M, Chatterji S, Ustun TB. Lifetime prevalence and age-of-onset distributions of mental disorders in the World Health Organization's World Mental Health Survey Initiative. World Psychiatry. 2007 Oct;6(3):168-76.
PMID: 18188442
citation: Baxter AJ, Vos T, Scott KM, Ferrari AJ, Whiteford HA. The global burden of anxiety disorders in 2010. Psychol Med. 2014 Aug;44(11):2363-74. doi: 10.1017/S0033291713003243. Epub 2014 Jan 22.
PMID: 24451993
citation: Fineberg NA, Haddad PM, Carpenter L, Gannon B, Sharpe R, Young AH, Joyce E, Rowe J, Wellsted D, Nutt DJ, Sahakian BJ. The size, burden and cost of disorders of the brain in the UK. J Psychopharmacol. 2013 Sep;27(9):761-70. doi: 10.1177/0269881113495118. Epub 2013 Jul 24.
PMID: 23884863
citation: Mendlowicz MV, Stein MB. Quality of life in individuals with anxiety disorders. Am J Psychiatry. 2000 May;157(5):669-82. doi: 10.1176/appi.ajp.157.5.669.
PMID: 10784456
responsible party type: Principal Investigator
investigator affiliation: Ruhr University of Bochum
investigator full name: Dr. Tobias Teismann
investigator title: Dr. Tobias Teismann
mesh term: Panic Disorder
mesh term: Agoraphobia
sharing ipd: Yes
ipd description: Data will be available upon request.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: Available upon request from August 2021
ipd access criteria: Researchers in the field of anxiety disorders, meta-analysis, contact: tobias Teismann