NCT01253486

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

2.7 years

First QC Date

December 2, 2010

Last Update Submit

February 11, 2021

Conditions

Ischemic Heart DiseaseObesity

Keywords

expressive writingcardiac rehabilitation

Outcome Measures

Primary Outcomes (4)

  • SF12

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

    1 year

  • BDI-II

    The Beck Depression Inventory is a measure of depressive symptoms

    1 year

  • BDI

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

    1 year

  • Brief-PTGI

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

    1 year

Secondary Outcomes (3)

  • BMI

    1 year

  • Multiple Coronary Risk Factors

    1 year

  • METs

    1 year

Study Arms (4)

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

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

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

Behavioral: Sham Comparator: Neutral writing

Control condition

NO INTERVENTION

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

Interventions

Disease-related Expressive writingBEHAVIORAL

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.

Disease-related expressive writing
Active Comparator: Traditional expressive writingBEHAVIORAL

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

Traditional expressive writing
Sham Comparator: Neutral writingBEHAVIORAL

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

Neutral writing

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • obesity
  • Ischemic Heart disease
  • Signed informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS

Verbania, 28921, Italy

Location

Related Publications (2)

  • 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.

    PMID: 17073523BACKGROUND

  • 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.

    PMID: 21740564DERIVED

Related Links

MeSH Terms

Conditions

Myocardial IschemiaObesity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gianluca Castelnuovo, Ph.D.

    Istituto Auxologico Italiano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 3, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2012

Study Completion

May 1, 2013

Last Updated

February 12, 2021

Record last verified: 2021-02

Locations

IT(1)