Protocol summary

Summary
Objectives: Comparing the Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT) on anxiety, depression and quality of life of patients with myocardial infarction. Design: This Study will be a Clinical Trial. Ninety (90) patients with myocardial infarction selected based on the purposive sampling. Patients were randomly divided into two experimental and one control groups (30 patients in each group) Major Inclusion and Exclusion criteria: Myocardial infarction was diagnosed by a cardiologist; hemodynamic stability. Exclusion criteria will be include lack of cooperation with the therapist; and intolerance to treatment method. Intervention: in one experimental group, Eye Movement Desensitization and Reprocessing treatment method will be done individually conduct for each patient in the consultation room within 8 one-hour sessions over a month. in another experimental group, Cognitive Behavioral Therapy method will be done individually conduct for each patient in the consultation room within 10 one-hour sessions over a month. In the control group, patients no receive any special treatment by the investigator. main outcome measures : data will be gather on anxiety, depression and quality of life at pretreatment and posttreatment .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016052428017N2
Registration date: 2016-09-10, 1395/06/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-10, 1395/06/20
Registrant information
Name
Mohammad Behnammoghadam
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 5041
Email address
m.behnammoghadam@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yasuj University of Medical Sciences
Expected recruitment start date
2016-04-22, 1395/02/03
Expected recruitment end date
2016-10-18, 1395/07/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of eye movement desensitization and reprocessing and cognitive behavioral therapy on anxiety, depression and quality of life in patients with myocardial infarction in critical care unit
Public title
Efficacy of eye movement desensitization and reprocessing and cognitive behavioral therapy on anxiety, depression and quality of life in patients with myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Myocardial infarction was diagnosed by a cardiologist; hemodynamic stability; age range between 30 to 60 years old. exclusion criteria: lack of cooperation with the therapist; and intolerance to treatment method.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization Will be based on a random numbers table

Secondary Ids

1

Registry name
...
Secondary trial Id
...
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Sciences
Street address
Shahid Motahari Blvd, Yasuj
City
Yasuj
Postal code
Approval date
2016-04-08, 1395/01/20
Ethics committee reference number
ir.yums.rec.1395.26

Health conditions studied

1

Description of health condition studied
Myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction

Primary outcomes

1

Description
Anxiety
Timepoint
Before and two months after intervention
Method of measurement
The Beck Anxity Inventory

2

Description
Depression
Timepoint
Before and two months after intervention
Method of measurement
The Beck Depression Inventory

Secondary outcomes

1

Description
Quality of life
Timepoint
Before and two months after intervention
Method of measurement
Quality of Life Questionnaire

Intervention groups

1

Description
Intervention group 1: Eye movement desensitization and reprocessing method will be done individually conduct for each patient in the consultation room within 8 one-hour sessions over a month. Intervention group 2: Cognitive Behavioral Therapy will be done individually conduct for each patient in the consultation room within 10 one-hour sessions over a month. Control group:The control group received no intervention.
Category
Behavior

2

Description
The control group received no intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Sajjad Hospital of Yasuj
Full name of responsible person
Mohammad behnammoghadam
Street address
Shahid Jalil Street, Yasuj
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Yasuj University of Medical Sciences
Full name of responsible person
Dr. Mousavi
Street address
Shahadat 12, Bagher Khan Blvd, Yasuj
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Yasuj 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
Yasuj University Of Medical Sciences
Full name of responsible person
Mohammad behnammoghadam
Position
MSc
Other areas of specialty/work
Street address
Shahid Motahari Blvd, Yasuj
City
Yasuj
Postal code
7591959497
Phone
+98 74 3322 5041
Fax
Email
mbehnammoghadam@yahoo.com; mbehnam1363@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University Of Medical Sciences
Full name of responsible person
Mohammad behnammoghadam
Position
MSc
Other areas of specialty/work
Street address
Shahadat 12, Bagher Khan Blvd, Yasuj
City
Yasuj
Postal code
Phone
+98 74 3322 5041
Fax
+98 74 3322 5041
Email
mbehnam1363@gmail.com; mbehnammoghadam@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University Of Medical Sciences
Full name of responsible person
Mohammad behnammoghadam
Position
MSc
Other areas of specialty/work
Street address
Shahadat 12, Bagher Khan Blvd, Yasuj
City
Yasuj
Postal code
7591959497
Phone
+98 74 3322 5041
Fax
Email
mbehnammoghadam@yahoo.com; mbehnam1363@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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