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Completed

NCT Number: NCT01253486

Expressive Writing for Heart Healing

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

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Key information

Conditions

Ischemic Heart Disease Body Weight Cardiovascular Diseases Heart Diseases Myocardial Ischemia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS

Verbania, 28921, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • obesity
  • Ischemic Heart disease
  • Signed informed consent

Exclusion criteria

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

Treatment and study plan

Disease-related Expressive writing

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  1. SF12

    Time frame: 1 year

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

  2. BDI-II

    Time frame: 1 year

    The Beck Depression Inventory is a measure of depressive symptoms

  3. BDI

    Time frame: 1 year

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

  4. Brief-PTGI

    Time frame: 1 year

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

Secondary outcomes

  1. BMI

    Time frame: 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

    Time frame: 1 year

    Hypertension, HDL, LDL,

  3. METs

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

Use of Expressive Writing in the Cardiac Rehabilitation of Obese In-patients With Ischemic Heart Disease (IHD)

Acronym: WrittenHeart

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Dec 3, 2010
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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