Expressive Writing for Heart Healing

NCT ID: NCT01253486

Last Updated: 2021-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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

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Ischemic Heart Disease Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Disease-related Expressive writing

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

Active Comparator: Traditional expressive writing

Intervention Type 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

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

Group Type SHAM_COMPARATOR

Sham Comparator: Neutral writing

Intervention Type 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

Control condition

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* obesity
* Ischemic Heart disease
* Signed informed consent

Exclusion Criteria

* Visual or manual limitations that preclude reading and writing
* Unwilling to participate
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Gianluca Castelnuovo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gianluca Castelnuovo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano

Locations

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San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS

Verbania, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 17073523 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21740564 (View on PubMed)

Related Links

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Other Identifiers

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GMM 2010

Identifier Type: -

Identifier Source: org_study_id

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