--- a +++ b/matching/trials/NCT00623454.xml @@ -0,0 +1,130 @@ +<?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 + and an XML DTD at: + https://clinicaltrials.gov/ct2/html/images/info/public.dtd --> + <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>