Expressive Writing for Heart Healing

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Use of Expressive Writing in the Cardiac Rehabilitation of Obese In-patients With Ischemic Heart Disease (IHD)

Conditions
-----------------
Ischemic Heart Disease, Obesity

Intervention / Treatment
-----------------
* Behavioral: Disease-related Expressive writing
* Behavioral: Active Comparator: Traditional expressive writing
* Behavioral: Sham Comparator: Neutral writing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obesity Ischemic Heart disease Signed informed consent Exclusion Criteria: Visual or manual limitations that preclude reading and writing Unwilling to participate

Ages Eligible for Study
-----------------
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disease-related expressive writing<br>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 | Behavioral: Disease-related Expressive writing<br>* 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.<br>|
| Active Comparator: Traditional expressive writing<br>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 | Behavioral: Active Comparator: Traditional expressive writing<br>* 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<br>|
| Sham Comparator: Neutral writing<br>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 | Behavioral: Sham Comparator: Neutral writing<br>* 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<br>|
| No Intervention: Control condition<br>Participants in the control condition do not receive any intervention and complete only the assessments | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF12 | The SF12 is a generic measure of both physical and emotional components of health-related quality of life | 1 year | 
| BDI-II | The Beck Depression Inventory is a measure of depressive symptoms | 1 year | 
| BDI | The Beck Anxiety Inventory is a measure of cognitive and somatic symptoms of anxiety | 1 year | 
| Brief-PTGI | The Brief Post-Traumatic Growth Inventory is a measure of positive growth following adversity | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | Body Mass Index (BMI) is a measure of obesity and is calculated as weight in kilograms divided by height in meters squared | 1 year | 
| Multiple Coronary Risk Factors | Hypertension, HDL, LDL, | 1 year | 
| METs | 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 | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
expressive writing, cardiac rehabilitation