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Expressive Writing for Heart Healing (WrittenHeart)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT01253486
First received: December 2, 2010
Last updated: July 4, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Ischemic Heart Disease
Obesity
 Behavioral: Disease-related Expressive writing
Behavioral: Active Comparator: Traditional expressive writing
Behavioral: Sham Comparator: Neutral writing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Use of Expressive Writing in the Cardiac Rehabilitation of Obese In-patients With Ischemic Heart Disease (IHD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Istituto Auxologico Italiano:

Primary Outcome Measures:
  • SF12 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The SF12 is a generic measure of both physical and emotional components of health-related quality of life

  • BDI-II [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The Beck Depression Inventory is a measure of depressive symptoms

  • BDI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The Beck Anxiety Inventory is a measure of cognitive and somatic symptoms of anxiety

  • Brief-PTGI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The Brief Post-Traumatic Growth Inventory is a measure of positive growth following adversity


Secondary Outcome Measures:
  • BMI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Hypertension, HDL, LDL,

  • METs [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253486

Locations
Italy
San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS
Verbania, Italy, 28921
Sponsors and Collaborators
Istituto Auxologico Italiano
Investigators
Principal Investigator: Gian Luca Castelnuovo, Ph.D. Istituto Auxologico Italiano
Study Chair: Luca Grappiolo Istituto Auxologico Italiano
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Castelnuovo Gian Luca, Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT01253486     History of Changes
Other Study ID Numbers: GMM 2010
Study First Received: December 2, 2010
Last Updated: July 4, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Istituto Auxologico Italiano:
expressive writing
cardiac rehabilitation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Obesity
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013