<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/NCT01693497</url>
  </required_header>
  <id_info>
    <org_study_id>Gestalt therapy for PTSD</org_study_id>
    <nct_id>NCT01693497</nct_id>
  </id_info>
  <brief_title>Comparison of Cognitive Processing Therapy (CPT) and Dialogical Exposure Therapy (DET) for Posttraumatic Stress Disorder</brief_title>
  <official_title>Comparison of a Gestalt-based Approach to PTSD Therapy With Cognitive Processing Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to compare two active psychological treatments for PTSD. One is an&#xD;
      established therapy, Cognitive Processing Therapy (CPT) which operates as a control condition&#xD;
      for a newly developed intervention, an integrative Gestalt-based trauma therapy, Dialogical&#xD;
      Exposure Therapy (DET). There is no inactive control condition. We expect the two therapies&#xD;
      to perform on a similar level, which would constitute evidence for the efficacy of DET.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2002</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">September 2011</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>PTBS Symptom Severity</measure>
    <time_frame>change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)</time_frame>
    <description>Even though participants are assessed by a clinical interview before entering the study, the primary outcome measure is the PDS which is applied before and after treatment as well as at 6-month follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PTSD Symptom change (IES-R)</measure>
    <time_frame>change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment). Also measured at each session (up to 24 time points between pre- and posttreatment).</time_frame>
    <description>The IES-R is a short instrument for the measurement of PTSD symptom severity. In this study, the IES-R is applied before every session in order to measure symptom change over the time of the therapy.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Brief Symptom Inventory</measure>
    <time_frame>change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)</time_frame>
    <description>The Brief Symptom Inventory (BSI) is a measure of general psychological distress.</description>
  </other_outcome>
  <other_outcome>
    <measure>Inventory of Interpersonal Problems (IIP)</measure>
    <time_frame>change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)</time_frame>
    <description>The IIP is a widely used instrument to measure interpersonal distress.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Dialogical exposure therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Psychotherapy based on a manual integrating Gestalt principles with cognitive-behavioral techniques.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive Processing Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cognitive Processing Therapy, a cognitive behavioral psychotherapy for PTSD patients. Based on a German manual adapted from Resick and Schnicke, 1993.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dialogical exposure therapy</intervention_name>
    <description>This 24-session treatment protocol includes cognitive-behavioral components integrated with a frame based on gestalt principles. There are four phases, safety, stabilization, confrontation and integration.</description>
    <arm_group_label>Dialogical exposure therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Processing Therapy (German Adaptation)</intervention_name>
    <description>This is a German adaptation of Cognitive Processing Therapy, developed by Prof. P. A. Resick. This intervention includes cognitive restructuring, a focus on the traumatic memory and a focus on issues that are likely to be problematic in traumatized individuals.</description>
    <arm_group_label>Cognitive Processing Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  main diagnosis of posttraumatic stress disorder&#xD;
&#xD;
          -  time since trauma is at least three months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute suicidal ideation&#xD;
&#xD;
          -  severe personality pathology&#xD;
&#xD;
          -  substance dependence&#xD;
&#xD;
          -  early childhood trauma (e.g. child sexual abuse)&#xD;
&#xD;
          -  history of psychosis&#xD;
&#xD;
          -  dissociative identity disorder&#xD;
&#xD;
          -  neurological impairment (e.g. craniocerebral injury with functional impairment)&#xD;
&#xD;
          -  severe pre-traumatic depression&#xD;
&#xD;
          -  ongoing psychotherapy&#xD;
&#xD;
          -  lack of motivation&#xD;
&#xD;
          -  lack of German language skills&#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>Willi Butollo, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ludwig-Maximilians - University of Munich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LS für Klinische Psychologie und Psychotherapie</name>
      <address>
        <city>Munich</city>
        <zip>80802</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 24, 2012</last_update_submitted>
  <last_update_submitted_qc>September 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>Willi Butollo</investigator_full_name>
    <investigator_title>Head of Clinical Psychology and Psychotherapy</investigator_title>
  </responsible_party>
  <keyword>Posttraumatic Stress Disorder</keyword>
  <keyword>PTSD</keyword>
  <keyword>psychotherapy</keyword>
  <keyword>randomized trial</keyword>
  <keyword>gestalt</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT01693497
org study id: Gestalt therapy for PTSD
nct id: NCT01693497
lead sponsor: 
has dmc: No
This study aims to compare two active psychological treatments for PTSD. One is an
      established therapy, Cognitive Processing Therapy (CPT) which operates as a control condition
      for a newly developed intervention, an integrative Gestalt-based trauma therapy, Dialogical
      Exposure Therapy (DET). There is no inactive control condition. We expect the two therapies
      to perform on a similar level, which would constitute evidence for the efficacy of DET.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PTBS Symptom Severity
time frame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)
description: Even though participants are assessed by a clinical interview before entering the study, the primary outcome measure is the PDS which is applied before and after treatment as well as at 6-month follow-up.
measure: PTSD Symptom change (IES-R)
time frame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment). Also measured at each session (up to 24 time points between pre- and posttreatment).
description: The IES-R is a short instrument for the measurement of PTSD symptom severity. In this study, the IES-R is applied before every session in order to measure symptom change over the time of the therapy.
measure: Brief Symptom Inventory
time frame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)
description: The Brief Symptom Inventory (BSI) is a measure of general psychological distress.
measure: Inventory of Interpersonal Problems (IIP)
time frame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)
description: The IIP is a widely used instrument to measure interpersonal distress.
arm group label: Dialogical exposure therapy
arm group type: Experimental
description: Psychotherapy based on a manual integrating Gestalt principles with cognitive-behavioral techniques.
arm group label: Cognitive Processing Therapy
arm group type: Active Comparator
description: Cognitive Processing Therapy, a cognitive behavioral psychotherapy for PTSD patients. Based on a German manual adapted from Resick and Schnicke, 1993.
intervention type: Behavioral
intervention name: Dialogical exposure therapy
description: This 24-session treatment protocol includes cognitive-behavioral components integrated with a frame based on gestalt principles. There are four phases, safety, stabilization, confrontation and integration.
arm group label: Dialogical exposure therapy
intervention type: Behavioral
intervention name: Cognitive Processing Therapy (German Adaptation)
description: This is a German adaptation of Cognitive Processing Therapy, developed by Prof. P. A. Resick. This intervention includes cognitive restructuring, a focus on the traumatic memory and a focus on issues that are likely to be problematic in traumatized individuals.
arm group label: Cognitive Processing Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Willi Butollo, Prof.
role: Principal Investigator
affiliation: Ludwig-Maximilians - University of Munich
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Willi Butollo
investigator title: Head of Clinical Psychology and Psychotherapy
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic