<?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>
