Expressive Writing for Heart Healing

Obesity Clinical Trial

— WrittenHeart  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253486
• Other study ID #: GMM 2010
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: May 2013

Study information

• Verified date: February 2021
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

• obesity

• Ischemic Heart disease

• Signed informed consent

Exclusion Criteria:

• Visual or manual limitations that preclude reading and writing

• Unwilling to participate

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Obesity

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS	Verbania

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006 Nov;132(6):823-65. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF12	The SF12 is a generic measure of both physical and emotional components of health-related quality of life	1 year
Primary	BDI-II	The Beck Depression Inventory is a measure of depressive symptoms	1 year
Primary	BDI	The Beck Anxiety Inventory is a measure of cognitive and somatic symptoms of anxiety	1 year
Primary	Brief-PTGI	The Brief Post-Traumatic Growth Inventory is a measure of positive growth following adversity	1 year
Secondary	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
Secondary	Multiple Coronary Risk Factors	Hypertension, HDL, LDL,	1 year
Secondary	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

External Links

•   Related Info