Expressive Writing for Heart Healing (WrittenHeart)

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Ischemic Heart Disease
• Intervention / Treatment: Behavioral: Disease-related Expressive writing; Behavioral: Active Comparator: Traditional expressive writing; Behavioral: Sham Comparator: Neutral writing

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verbania, Italy, 28921
    • San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• obesity
• Ischemic Heart disease
• Signed informed consent

Exclusion Criteria:

• Visual or manual limitations that preclude reading and writing
• Unwilling to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Disease-related expressive writing; 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; 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.
Active Comparator: Traditional expressive writing; 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; 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
Sham Comparator: Neutral writing; 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; 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
No Intervention: Control condition; 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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Investigators: Principal Investigator: Gianluca Castelnuovo, Ph.D., Istituto Auxologico Italiano

Publications and helpful links

General Publications

• Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006 Nov;132(6):823-65. doi: 10.1037/0033-2909.132.6.823.
• Manzoni GM, Castelnuovo G, Molinari E. The WRITTEN-HEART study (expressive writing for heart healing): rationale and design of a randomized controlled clinical trial of expressive writing in coronary patients referred to residential cardiac rehabilitation. Health Qual Life Outcomes. 2011 Jul 8;9:51. doi: 10.1186/1477-7525-9-51.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: December 2, 2010
• First Submitted That Met QC Criteria: December 2, 2010
• First Posted (Estimate): December 3, 2010

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: cardiac rehabilitation; expressive writing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: GMM 2010