Ischemic Heart DiseaseWrittenHeartNCT01253486
Expressive Writing for Heart Healing
A study testing Disease-related Expressive writing and Active Comparator: Traditional expressive writing in people with Ischemic Heart Disease and Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Ischemic Heart Disease, Obesity
- What is being tested?
- Disease-related Expressive writing and Active Comparator: Traditional expressive writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- obesity
- Ischemic Heart disease
- Signed informed consent
Who cannot join
- Visual or manual limitations that preclude reading and writing
- Unwilling to participate
Trial locations and contacts
1 site in 1 country.
Italy1 site
San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS
Verbania, 28921
About this study
Official title: 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
Read the 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.
- Conditions
- Ischemic Heart Disease, Obesity
- Being tested
- Disease-related Expressive writing, Active Comparator: Traditional expressive writing, Sham Comparator: Neutral writing
- Keywords
- expressive writing, cardiac rehabilitation
- Medical subject headings
- Myocardial Ischemia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease-related Expressive writingBehavioural
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 writingBehavioural
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 writingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Disease-related expressive writing | Experimental | 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 Receives: Behavioral: Disease-related Expressive writing |
| Traditional expressive writing | Active comparator | 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 Receives: Behavioral: Active Comparator: Traditional expressive writing |
| Neutral writing | Sham comparator | 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 Receives: Behavioral: Sham Comparator: Neutral writing |
| Control condition | No intervention | Participants in the control condition do not receive any intervention and complete only the assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF12
The SF12 is a generic measure of both physical and emotional components of health-related quality of life
Measured: 1 year
BDI-II
The Beck Depression Inventory is a measure of depressive symptoms
Measured: 1 year
BDI
The Beck Anxiety Inventory is a measure of cognitive and somatic symptoms of anxiety
Measured: 1 year
Brief-PTGI
The Brief Post-Traumatic Growth Inventory is a measure of positive growth following adversity
Measured: 1 year
Secondary outcomes (3)
BMI
Body Mass Index (BMI) is a measure of obesity and is calculated as weight in kilograms divided by height in meters squared
Measured: 1 year
Multiple Coronary Risk Factors
Hypertension, HDL, LDL,
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Castelnuovo, Istituto Auxologico Italiano
- Investigators
- Gianluca Castelnuovo, Ph.D., Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253486
- Sponsor's protocol ID
- GMM 2010
- Acronym
- WrittenHeart
- Status last verified
- Feb 2021
- First submitted
- 2 Dec 2010
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17073523Manzoni 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.
PubMed 21740564
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Expressive Writing in the Cardiac Rehabilitation of Obese In-patients With Ischemic Heart Disease (IHD)
- ClinicalTrials.gov ID
- NCT01253486
- Acronym / sponsor ID
- WrittenHeart / GMM 2010
- Conditions
- Ischemic Heart Disease, Obesity
- Keywords
- expressive writing, cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Disease-related expressive writing | Experimental | Behavioral: Disease-related Expressive writingParticipants 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 |
| Traditional expressive writing | Active comparator | Behavioral: Active Comparator: Traditional expressive writingParticipants 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 |
| Neutral writing | Sham comparator | Behavioral: Sham Comparator: Neutral writingParticipants in the neutral writing condition write about the facts about cardiac disease, for at least 20 minutes each time, during a two week period |
| Control condition | No intervention | –Participants in the control condition do not receive any intervention and complete only the assessments |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- obesity
- Ischemic Heart disease
- Signed informed consent
Key exclusion criteria (2 listed)
- Visual or manual limitations that preclude reading and writing
- Unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disease-related Expressive writingParticipants 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. | Behavioural | Disease-related expressive writing |
| Active Comparator: Traditional expressive writingParticipants 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 | Behavioural | Traditional expressive writing |
| Sham Comparator: Neutral writingParticipants in the neutral writing condition write about the facts about cardiac disease, for at least 20 minutes each time, during a two week period | Behavioural | Neutral writing |
Primary outcome
SF12
Time frame: 1 year
The SF12 is a generic measure of both physical and emotional components of health-related quality of life
BDI-II
Time frame: 1 year
The Beck Depression Inventory is a measure of depressive symptoms
BDI
Time frame: 1 year
The Beck Anxiety Inventory is a measure of cognitive and somatic symptoms of anxiety
Brief-PTGI
Time frame: 1 year
The Brief Post-Traumatic Growth Inventory is a measure of positive growth following adversity
3 secondary outcomes
BMI
Time frame: 1 year
Multiple Coronary Risk Factors
Time frame: 1 year
METs
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Background: PubMed 17073523Frattaroli 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.
- Derived from this study: PubMed 21740564Manzoni 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluca Castelnuovo, Ph.D. principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disease-related Expressive writing and Active Comparator: Traditional expressive writing in people with Ischemic Heart Disease and Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF12 (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01253486, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.