<?xml version="1.0" encoding="UTF-8"?>
<clinical_study rank="153549">
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd
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  <required_header>
    <download_date>ClinicalTrials.gov processed this data on December 16, 2015</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/show/NCT00623454</url>
  </required_header>
  <id_info>
    <org_study_id>4.2006.1110 (REK)</org_study_id>
    <nct_id>NCT00623454</nct_id>
  </id_info>
  <brief_title>Non Cardiac Chest Pain and Benign Palpitations</brief_title>
  <official_title>A Randomized Controlled Trial of Cognitive Behavioural Therapy for Non-cardiac Chest Pain and Palpitations.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <authority>Norway:National Committee for Medical and Health Research Ethics</authority>
    <authority>Norway: Norwegian Social Science Data Services</authority>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      All Patients between 18 and 65 years are asked 6 month after investigation for chest pain or
      palpitation at Cardiological Out-patient Clinic, Molde Hospital, about if they still have
      symptoms of chest pain or palpitation. If they still have some of the symptoms they are
      invited to participate in a coping course to learn a better way to deal with their symptoms.

      The coping course consist of three sessions of cognitive behaviour therapy.
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2007</start_date>
  <completion_date type="Actual">April 2009</completion_date>
  <primary_completion_date type="Actual">April 2009</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <study_design>Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment</study_design>
  <primary_outcome>
    <measure>Body sensation questionnaire (BSQ)</measure>
    <time_frame>end of treatment, after 3 month and after 12 month</time_frame>
    <safety_issue>No</safety_issue>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory (BDI)</measure>
    <time_frame>end of treatment, after 3 and 12 months</time_frame>
    <safety_issue>No</safety_issue>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Anxiety/Depression in Cardiological Unit</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behaviour therapy</intervention_name>
    <description>Three hours with cognitive therapy focusing on the chest pain and palpitations.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:

          -  investigated for chest pain or palpitation 6 month ago at Cardiological Out-patient
             Clinic, Molde Hospital

          -  suffer of chest pain or palpitations

        Exclusion Criteria:

          -  do not speak norwegian properly

          -  mentally retarded

          -  psychosis last 6 month

          -  current alcohol or drug misuse
      </textblock>
    </criteria>
    <gender>Both</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Egil Jonsbu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiological Out-patient Clinic</name>
      <address>
        <city>Molde</city>
        <zip>6400</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <results_reference>
    <citation>Jonsbu E, Dammen T, Morken G, Martinsen EW. Patients with noncardiac chest pain and benign palpitations referred for cardiac outpatient investigation: a 6-month follow-up. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):406-12. doi: 10.1016/j.genhosppsych.2010.03.003. Epub 2010 Apr 13.</citation>
    <PMID>20633745</PMID>
  </results_reference>
  <verification_date>August 2011</verification_date>
  <lastchanged_date>August 25, 2011</lastchanged_date>
  <firstreceived_date>February 14, 2008</firstreceived_date>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anxiety</keyword>
  <keyword>panic disorder</keyword>
  <keyword>chest pain</keyword>
  <keyword>palpitations</keyword>
  <is_fda_regulated>No</is_fda_regulated>
  <has_expanded_access>No</has_expanded_access>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm  -->
    <mesh_term>Chest Pain</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                -->
</clinical_study>