A randomized controlled trial study of 48 recently hospitalized MI patients will be conducted (24 in intervention group and 24 in control group).
This randomized controlled trial study was done to compare quality of life, anxiety and depression in patients with myocardial infarction who discharged from hospital undergone an illness perception improvement intervention (study group) to the routine discharged patients (control group).
Intervention group will be trained to understand the disease by a mental health counselor in three half an hour sessions for 3 consecutive days. Data will be collected from 3 questionnaire (Hospital Anxiety Depression Scale (H.A.D.S), The World Health Organization Quality of Life Questionnaire (short form) and Illness Perceptions Questionnaire Brief (IPQ-B)) at admission, 1.5 and 3 months post-discharge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507262266N4
Registration date:2015-10-30, 1394/08/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-30, 1394/08/08
Registrant information
Name
Gholamreza Kheirabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2135
Email address
kheirabadi@bsrc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-10-30, 1393/08/08
Expected recruitment end date
2015-05-30, 1394/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of illness perception focused intervention on quality of life, anxiety and depression in patients with myocardial infarction
Public title
Illness perception and Myocardial Infarction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Myocardial Infarction.
Exclusion criteria: Myocardial Infarct secondary to bypass surgery or angioplasty; History of psychiatric disorders (anxiety or depression); being on treatment for depression or anxiety ; substance abuse or dependence .
Age
From 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Iran
City
isfahan
Postal code
Approval date
2014-10-25, 1393/08/03
Ethics committee reference number
393553
Health conditions studied
1
Description of health condition studied
Myocardial Infarction
ICD-10 code
120-125
ICD-10 code description
myocardial infarction specified as acute or with a stated duration of 4 weeks (28 days) or less from onset
Primary outcomes
1
Description
Quality of life
Timepoint
0, 1.5 and 3 months
Method of measurement
Questionair
Secondary outcomes
1
Description
Anxiety and Depression
Timepoint
0, 1.5 and 3 months
Method of measurement
Questionair
2
Description
Anxiety and depression
Timepoint
0, 1.5 and 3 months
Method of measurement
Questionair
Intervention groups
1
Description
Intervention group: psycho-education
Category
Other
2
Description
control group: free speaking as placebo.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran, Alzahra and Khorshid hospitals
Full name of responsible person
Gholam Reza Kheirabadi
Street address
Behavioral Sciences Resaerch Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Nematbakhsh
Street address
Isfahan University of Medical Sciences, Vice chancellor fo research
City
Isfahan
Grant name
Grant code / Reference number
393553
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Gholam Reza kheirabadi
Position
Academic member
Other areas of specialty/work
Street address
behavioral Sciences Resaerch Center
City
Isfahan
Postal code
81458-31451
Phone
+98 31 3222 2135
Fax
+98 31 3222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Dr Gholam Reza kheirabadi
Position
psychiatrist
Other areas of specialty/work
Street address
Behaviora Sciences Resaerch Center
City
Isfahan
Postal code
81458-31451
Phone
+98 31 3222 2135
Fax
+98 31 3222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Gholam Reza kheirabadi
Position
psychiatrist
Other areas of specialty/work
Street address
Isfahan University of Medical Science
City
Isfahan
Postal code
81458-31451
Phone
+98 31 3222 2135
Fax
+98 31 3222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)