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

December 2, 2010
July 4, 2011
January 2010
April 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01253486 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Expressive Writing for Heart Healing
Use of Expressive Writing in the Cardiac Rehabilitation of Obese In-patients With Ischemic Heart Disease (IHD)

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Ischemic Heart Disease
  • Obesity
  • 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.
  • 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
  • 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
  • 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
    Intervention: Behavioral: Disease-related Expressive writing
  • 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
    Intervention: Behavioral: Active Comparator: Traditional expressive writing
  • 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
    Intervention: Behavioral: Sham Comparator: Neutral writing
  • No Intervention: Control condition
    Participants in the control condition do not receive any intervention and complete only the assessments

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
May 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • obesity
  • Ischemic Heart disease
  • Signed informed consent

Exclusion Criteria:

  • Visual or manual limitations that preclude reading and writing
  • Unwilling to participate
Both
up to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01253486
GMM 2010
No
Castelnuovo Gian Luca, Istituto Auxologico Italiano
Istituto Auxologico Italiano
Not Provided
Principal Investigator: Gian Luca Castelnuovo, Ph.D. Istituto Auxologico Italiano
Study Chair: Luca Grappiolo Istituto Auxologico Italiano
Istituto Auxologico Italiano
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP