--- a
+++ b/matching/trials/NCT01253486.xml
@@ -0,0 +1,207 @@
+<?xml version="1.0" encoding="UTF-8"?>
+<clinical_study rank="105722">
+  <!-- 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/NCT01253486</url>
+  </required_header>
+  <id_info>
+    <org_study_id>GMM 2010</org_study_id>
+    <nct_id>NCT01253486</nct_id>
+  </id_info>
+  <brief_title>Expressive Writing for Heart Healing</brief_title>
+  <acronym>WrittenHeart</acronym>
+  <official_title>Use of Expressive Writing in the Cardiac Rehabilitation of Obese In-patients With Ischemic Heart Disease (IHD)</official_title>
+  <sponsors>
+    <lead_sponsor>
+      <agency>Istituto Auxologico Italiano</agency>
+      <agency_class>Other</agency_class>
+    </lead_sponsor>
+  </sponsors>
+  <source>Istituto Auxologico Italiano</source>
+  <oversight_info>
+    <authority>Italy: Ethics Committee</authority>
+    <has_dmc>No</has_dmc>
+  </oversight_info>
+  <brief_summary>
+    <textblock>
+      This study will determine whether the psychological and physical benefits of expressive
+      writing extend to obese in-patients with Ischemic Heart Disease (IHD)referred to cardiac
+      rehabilitation
+    </textblock>
+  </brief_summary>
+  <detailed_description>
+    <textblock>
+      Expressive writing, for as little as 3-5 sessions of 20 minutes, has been found to improve
+      both physical and psychological health based on health outcome measures such as number of
+      doctor's visits and hospital days, blood pressure control, lung and immune function, pain,
+      anxiety and depression. Given its simplicity and obvious advantages in terms of
+      cost-effectiveness, expressive writing has great potential as a therapeutic tool or as a
+      means of self-help, either alone or as an adjunct to traditional therapies. This modality
+      has not been studied in obese patients with Ischemic Heart Disease.
+    </textblock>
+  </detailed_description>
+  <overall_status>Completed</overall_status>
+  <start_date>January 2010</start_date>
+  <completion_date type="Actual">May 2013</completion_date>
+  <primary_completion_date type="Actual">September 2012</primary_completion_date>
+  <phase>N/A</phase>
+  <study_type>Interventional</study_type>
+  <study_design>Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment</study_design>
+  <primary_outcome>
+    <measure>SF12</measure>
+    <time_frame>1 year</time_frame>
+    <safety_issue>No</safety_issue>
+    <description>The SF12 is a generic measure of both physical and emotional components of health-related quality of life</description>
+  </primary_outcome>
+  <primary_outcome>
+    <measure>BDI-II</measure>
+    <time_frame>1 year</time_frame>
+    <safety_issue>No</safety_issue>
+    <description>The Beck Depression Inventory is a measure of depressive symptoms</description>
+  </primary_outcome>
+  <primary_outcome>
+    <measure>BDI</measure>
+    <time_frame>1 year</time_frame>
+    <safety_issue>No</safety_issue>
+    <description>The Beck Anxiety Inventory is a measure of cognitive and somatic symptoms of anxiety</description>
+  </primary_outcome>
+  <primary_outcome>
+    <measure>Brief-PTGI</measure>
+    <time_frame>1 year</time_frame>
+    <safety_issue>No</safety_issue>
+    <description>The Brief Post-Traumatic Growth Inventory is a measure of positive growth following adversity</description>
+  </primary_outcome>
+  <secondary_outcome>
+    <measure>BMI</measure>
+    <time_frame>1 year</time_frame>
+    <safety_issue>No</safety_issue>
+    <description>Body Mass Index (BMI) is a measure of obesity and is calculated as weight in kilograms divided by height in meters squared</description>
+  </secondary_outcome>
+  <secondary_outcome>
+    <measure>Multiple Coronary Risk Factors</measure>
+    <time_frame>1 year</time_frame>
+    <safety_issue>No</safety_issue>
+    <description>Hypertension, HDL, LDL,</description>
+  </secondary_outcome>
+  <secondary_outcome>
+    <measure>METs</measure>
+    <time_frame>1 year</time_frame>
+    <safety_issue>No</safety_issue>
+    <description>Metabolic equivalents are a measure of exercise capacity. 1 MET represents the amount of oxygen consumed at rest and is equal to approximately 3.5 ml O2 kg-1 min-1</description>
+  </secondary_outcome>
+  <number_of_arms>4</number_of_arms>
+  <enrollment type="Actual">100</enrollment>
+  <condition>Ischemic Heart Disease</condition>
+  <condition>Obesity</condition>
+  <arm_group>
+    <arm_group_label>Disease-related expressive writing</arm_group_label>
+    <arm_group_type>Experimental</arm_group_type>
+    <description>Participants in the disease-related expressive writing condition write about their feelings about cardiac disease four times, for at least 20 minutes each time, during a two week period</description>
+  </arm_group>
+  <arm_group>
+    <arm_group_label>Traditional expressive writing</arm_group_label>
+    <arm_group_type>Active Comparator</arm_group_type>
+    <description>Participants in the traditional expressive writing condition write about their feelings about one or more stressful experiences they lived in the past, for at least 20 minutes each time, during a two week period</description>
+  </arm_group>
+  <arm_group>
+    <arm_group_label>Neutral writing</arm_group_label>
+    <arm_group_type>Sham Comparator</arm_group_type>
+    <description>Participants in the neutral writing condition write about the facts about cardiac disease, for at least 20 minutes each time, during a two week period</description>
+  </arm_group>
+  <arm_group>
+    <arm_group_label>Control condition</arm_group_label>
+    <arm_group_type>No Intervention</arm_group_type>
+    <description>Participants in the control condition do not receive any intervention and complete only the assessments</description>
+  </arm_group>
+  <intervention>
+    <intervention_type>Behavioral</intervention_type>
+    <intervention_name>Disease-related Expressive writing</intervention_name>
+    <description>Participants in the disease-related expressive writing condition write about their feelings about cardiac disease four times, for at least 20 minutes each time, during a two week period.</description>
+    <arm_group_label>Disease-related expressive writing</arm_group_label>
+  </intervention>
+  <intervention>
+    <intervention_type>Behavioral</intervention_type>
+    <intervention_name>Active Comparator: Traditional expressive writing</intervention_name>
+    <description>Participants in the traditional expressive writing condition write about their feelings about one or more stressful experiences they lived in the past, for at least 20 minutes each time, during a two week period</description>
+    <arm_group_label>Traditional expressive writing</arm_group_label>
+  </intervention>
+  <intervention>
+    <intervention_type>Behavioral</intervention_type>
+    <intervention_name>Sham Comparator: Neutral writing</intervention_name>
+    <description>Participants in the neutral writing condition write about the facts about cardiac disease, for at least 20 minutes each time, during a two week period</description>
+    <arm_group_label>Neutral writing</arm_group_label>
+  </intervention>
+  <eligibility>
+    <criteria>
+      <textblock>
+        Inclusion Criteria:
+
+          -  obesity
+
+          -  Ischemic Heart disease
+
+          -  Signed informed consent
+
+        Exclusion Criteria:
+
+          -  Visual or manual limitations that preclude reading and writing
+
+          -  Unwilling to participate
+      </textblock>
+    </criteria>
+    <gender>Both</gender>
+    <minimum_age>N/A</minimum_age>
+    <maximum_age>70 Years</maximum_age>
+    <healthy_volunteers>No</healthy_volunteers>
+  </eligibility>
+  <overall_official>
+    <last_name>Gianluca Castelnuovo, Ph.D.</last_name>
+    <role>Principal Investigator</role>
+    <affiliation>Istituto Auxologico Italiano</affiliation>
+  </overall_official>
+  <location>
+    <facility>
+      <name>San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS</name>
+      <address>
+        <city>Verbania</city>
+        <zip>28921</zip>
+        <country>Italy</country>
+      </address>
+    </facility>
+  </location>
+  <location_countries>
+    <country>Italy</country>
+  </location_countries>
+  <link>
+    <url>http://www.auxologico.it</url>
+  </link>
+  <reference>
+    <citation>Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006 Nov;132(6):823-65.</citation>
+    <PMID>17073523</PMID>
+  </reference>
+  <verification_date>September 2013</verification_date>
+  <lastchanged_date>September 23, 2013</lastchanged_date>
+  <firstreceived_date>December 2, 2010</firstreceived_date>
+  <responsible_party>
+    <responsible_party_type>Principal Investigator</responsible_party_type>
+    <investigator_affiliation>Istituto Auxologico Italiano</investigator_affiliation>
+    <investigator_full_name>Gianluca Castelnuovo</investigator_full_name>
+    <investigator_title>Professor</investigator_title>
+  </responsible_party>
+  <keyword>expressive writing</keyword>
+  <keyword>cardiac rehabilitation</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>Coronary Artery Disease</mesh_term>
+    <mesh_term>Heart Diseases</mesh_term>
+    <mesh_term>Myocardial Ischemia</mesh_term>
+  </condition_browse>
+  <!-- Results have not yet been posted for this study                                -->
+</clinical_study>