This clinical trial will be done on thirty Myocardial Infarction patient referring Darrehshahr Hospital. They will be divided in two control and intervention groups with pretest and post test. Eligible participants randomly divided in two groups: intervention group (n=15) and control one (n=15). At the beginning of study after getting written consent for each person the demographic characteristics and GHQ questionnaire will be completed. After random allocation, for the intervention group eight cognitive behavioral intervention session hold by the researcher. The first session one month after Myocardial Infarction, and next sessions once a week consisting 60 minutes in hospitals clinic. There is no intervention in control group. One week after finishing the sessions, GHQ questionnaire will be completed by both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013111913568N2
Registration date:2014-02-23, 1392/12/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-23, 1392/12/04
Registrant information
Name
Rostam Jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3724 6613
Email address
rjalali@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-12-06, 1392/09/15
Expected recruitment end date
2014-02-04, 1392/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive behavioral intervention on mental health situation in Myocardial Infarction patients.
Public title
The effect of cognitive behavioral intervention on mental health in Myocardial Infarction patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having an experience of an myocardial infarction; and age range between 35-65 years; education high school or higher degrees; completing written informed consent. Exclusion criteria: not interesting for continuing; having a remarkable mental disorder; patients death.
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Kermanshah University of Medical Science
Street address
Shahid Beheshti Blvd
City
kermanshah
Postal code
Approval date
2013-11-09, 1392/08/18
Ethics committee reference number
33917
Health conditions studied
1
Description of health condition studied
Myocardial Infarction Disease
ICD-10 code
I21
ICD-10 code description
Acute Myocardial Infarction
Primary outcomes
1
Description
Mental Health
Timepoint
Before and one month after intervention.
Method of measurement
GHQ-28 questionnaire.
Secondary outcomes
1
Description
Physical Health
Timepoint
Before and one month after intervention.
Method of measurement
GHQ-28 questionnaire.
2
Description
Anxiety
Timepoint
Before and one month after intervention.
Method of measurement
GHQ-28 Questionnaire.
3
Description
Depression
Timepoint
Before and one month after intervention.
Method of measurement
GHQ-28 Questionnaire.
Intervention groups
1
Description
There is no intervention in control group but they received ordinary treatment.
Category
Rehabilitation
2
Description
In this study, the researcher hold eight cognitive behavioral intervention session(once a week lasting 60 minutes)for the intervention group. The first session once a month after Myocardial Infarction and the next sessions are held once a week in a 7 weeks duration.