WrittenHeart: Expressive Writing for Heart Healing

• Sponsor: Istituto Auxologico Italiano (Other)
• Overall Status: Completed
• CT.gov ID: NCT01253486
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 4
• Duration (Months): 40
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease; Obesity	Behavioral: Disease-related Expressive writing; Behavioral: Active Comparator: Traditional expressive writing; Behavioral: Sham Comparator: Neutral writing	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Use of Expressive Writing in the Cardiac Rehabilitation of Obese In-patients With Ischemic Heart Disease (IHD)
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. SF12 [1 year]

   The SF12 is a generic measure of both physical and emotional components of health-related quality of life

2. BDI-II [1 year]

   The Beck Depression Inventory is a measure of depressive symptoms

3. BDI [1 year]

   The Beck Anxiety Inventory is a measure of cognitive and somatic symptoms of anxiety

4. Brief-PTGI [1 year]

   The Brief Post-Traumatic Growth Inventory is a measure of positive growth following adversity

Secondary Outcome Measures

1. 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

2. Multiple Coronary Risk Factors [1 year]

   Hypertension, HDL, LDL,

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• obesity

• Ischemic Heart disease

• Signed informed consent

Exclusion Criteria:

• Visual or manual limitations that preclude reading and writing

• Unwilling to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS	Verbania		Italy	28921

Sponsors and Collaborators

• Istituto Auxologico Italiano

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

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

• Responsible Party: Gianluca Castelnuovo, Professor, Istituto Auxologico Italiano
• ClinicalTrials.gov Identifier: NCT01253486
• Other Study ID Numbers: GMM 2010
• First Posted: Dec 3, 2010
• Last Update Posted: Feb 12, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Gianluca Castelnuovo, Professor, Istituto Auxologico Italiano: expressive writing; cardiac rehabilitation
• Additional relevant MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease

Study Results

No Results Posted as of Feb 12, 2021