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Expressive Writing for Heart Healing (WrittenHeart)

Primary Purpose

Ischemic Heart Disease, Obesity

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Disease-related Expressive writing
Active Comparator: Traditional expressive writing
Sham Comparator: Neutral writing
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring expressive writing, cardiac rehabilitation

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • obesity
  • Ischemic Heart disease
  • Signed informed consent

Exclusion Criteria:

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

Sites / Locations

  • San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Sham Comparator

No Intervention

Arm Label

Disease-related expressive writing

Traditional expressive writing

Neutral writing

Control condition

Arm Description

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

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

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

Participants in the control condition do not receive any intervention and complete only the assessments

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2010
Last Updated
February 11, 2021
Sponsor
Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT01253486
Brief Title
Expressive Writing for Heart Healing
Acronym
WrittenHeart
Official Title
Use of Expressive Writing in the Cardiac Rehabilitation of Obese In-patients With Ischemic Heart Disease (IHD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Auxologico Italiano

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Obesity
Keywords
expressive writing, cardiac rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Disease-related expressive writing
Arm Type
Experimental
Arm Description
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
Arm Title
Traditional expressive writing
Arm Type
Active Comparator
Arm Description
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
Arm Title
Neutral writing
Arm Type
Sham Comparator
Arm Description
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
Arm Title
Control condition
Arm Type
No Intervention
Arm Description
Participants in the control condition do not receive any intervention and complete only the assessments
Intervention Type
Behavioral
Intervention Name(s)
Disease-related Expressive writing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Comparator: Traditional expressive writing
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Sham Comparator: Neutral writing
Intervention Description
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
Primary Outcome Measure Information:
Title
SF12
Description
The SF12 is a generic measure of both physical and emotional components of health-related quality of life
Time Frame
1 year
Title
BDI-II
Description
The Beck Depression Inventory is a measure of depressive symptoms
Time Frame
1 year
Title
BDI
Description
The Beck Anxiety Inventory is a measure of cognitive and somatic symptoms of anxiety
Time Frame
1 year
Title
Brief-PTGI
Description
The Brief Post-Traumatic Growth Inventory is a measure of positive growth following adversity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
BMI
Description
Body Mass Index (BMI) is a measure of obesity and is calculated as weight in kilograms divided by height in meters squared
Time Frame
1 year
Title
Multiple Coronary Risk Factors
Description
Hypertension, HDL, LDL,
Time Frame
1 year
Title
METs
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianluca Castelnuovo, Ph.D.
Organizational Affiliation
Istituto Auxologico Italiano
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS
City
Verbania
ZIP/Postal Code
28921
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17073523
Citation
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.
Results Reference
background
PubMed Identifier
21740564
Citation
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.
Results Reference
derived
Links:
URL
http://www.auxologico.it
Description
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Expressive Writing for Heart Healing

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