Expressive Writing for Heart Healing

Not Applicable

Completed

• Conditions: Obesity; Ischemic Heart Disease
• Interventions: Behavioral: Disease-related Expressive writing

• Registration Number: NCT01253486
• Lead Sponsor: Istituto Auxologico Italiano

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Primary Completion: 2012-09
• Study Completion: 2013-05
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• obesity
• Ischemic Heart disease
• Signed informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Disease-related expressive writing	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS; 🇮🇹 Verbania, Italy