Determining The efficacy of cognitive-behavioral therapy based on Rumination on depression, anxiety and hostility in patients undergoing cardiac rehabilitation
Design
The clinical trial is divided into two groups: rehabilitation intervention and psychotherapy and one control group. The assignment in the groups is randomly and number of sample is 48 patients.
Settings and conduct
First,After obtaining permission from related authorities, referring to the heart centers (Sadr heart center). After obtaining the informed consent the PHQ-9 questionnaires, BAI anxiety inventory and The Aggression Questionnaire- AQ will be delivered to patients. Then, 48 patients will be selected according to the entry and exit criteria.
Participants/Inclusion and exclusion criteria
inclusion criteria: Open heart surgery following coronary heart disease, ability to participate in a rehabilitation program and doing homework with a cardiologist's diagnosis and rehabilitation, a mild to moderate score in the questionnaires, having reading and writing skills, lack of severe mental disorder,
exclusion criteria: Having cognitive disorders such as Alzheimer's and dementia, Having thyroid problems.
Intervention groups
INT1: Cognitive behavioral therapy based on rumination
INT2: rehabilitation
CONTROL
Main outcome variables
Depression, Anxiety, Hostility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181224042100N1
Registration date:2019-03-27, 1398/01/07
Registration timing:retrospective
Last update:2019-03-27, 1398/01/07
Update count:0
Registration date
2019-03-27, 1398/01/07
Registrant information
Name
Mahdi Fatemizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6636 7569
Email address
m4567458@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-15, 1397/04/24
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2018-10-23, 1397/08/01
Trial completion date
2018-12-21, 1397/09/30
Scientific title
The efficacy of cognitive-behavioral therapy based on Rumination on depression, anxiety and hostility in patients undergoing cardiac rehabilitation
Public title
The efficacy of cognitive-behavioral therapy based on Rumination on depression, anxiety and hostility in cardiac patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Open heart surgery following coronary heart disease
Ability to participate in the rehabilitation program and doing assignments with a diagnosis of cardiologist and rehabilitation specialist
A mild or moderate score in the questionnaire (5 upwards at PHQ-9, 8 up on BAI, and 40 up at BPAQ)
Have reading and writing skills
No other physical illness that limits attendance at meetings
No change in psychiatric medications from one month before intervention
No history of receiving psychotherapy before intervention
Age 40 to 70 years
Exclusion criteria:
Having cognitive disorders such as Alzheimer's and dementia
having severe mental disorder (Personality disorders, Psychotic disorders and Dissociatives disorders)
Thyroid Problems
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
48
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
After having the entry criteria, one number was assigned to each person, and the numbers were assigned to three groups of intervention, rehabilitation and control according to the random numbers table.
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
Ethics committee of Shahid Beheshti of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Eraby street, Student Blvd, Velenjk, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.SBMU.MSP.REC.1397.587
Health conditions studied
1
Description of health condition studied
cardiovascular
ICD-10 code
I51.6
ICD-10 code description
Cardiovascular disease, unspecified
2
Description of health condition studied
depression
ICD-10 code
F32
ICD-10 code description
In typical mild, moderate, or severe depressive episodes, the patient suffers from lowering of mood, reduction of energy, and decrease in activity.
3
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstance
4
Description of health condition studied
hostility
ICD-10 code
R45.5
ICD-10 code description
signs and symptoms constituting part of a mental disorder
Primary outcomes
1
Description
Depression
Timepoint
Pre-test, Post-test, after 2 month
Method of measurement
Beck depression questionnaire
2
Description
Anxiety
Timepoint
Pre-test, Post-test, after 2 month
Method of measurement
Beck Anxiety questionnaire
3
Description
Hostility
Timepoint
Pre-test, Post-test, after 2 month
Method of measurement
The Aggression Questionnaire- AQ
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive 12 sessions of cognitive-behavioral behavioral therapy based on Rumination for one session per week. The protocol has been devised to treat depression and And focuses on changing the rumination of patients.
Category
Treatment - Other
2
Description
Intervention group: The rehabilitation group will receive 40 sessions of rehabilitation program weekly in 3 sessions
Category
Rehabilitation
3
Description
Control group: The control group will be selected from the waiting list and will not receive any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized Clinic Heart of Sadr
Full name of responsible person
Arash Ghanavati
Street address
Specialized Clinic Heart of Sadr, firuze street, Vali Asr Square, Tehran
City
Tehran
Province
Tehran
Postal code
1593714317
Phone
+98 21 8603 4831
Email
rasoul.2828@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
private organization
Full name of responsible person
Mahdi fatemizadeh
Street address
number 121, valiasr town, bojnurd, north khorasan
City
bojnourd
Province
North Khorasan
Postal code
9417896483
Phone
+98 58 3225 4183
Email
rasoul.2828@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
private organization
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rasoul mohammadian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
10th Alley, Resalat street
City
Shahindezh
Province
West Azarbaijan
Postal code
5981944451
Phone
+98 44 4632 1250
Email
rasoul.2828@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rasoul Mohammadian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
10th Alley, Resalat street
City
shahindezh
Province
West Azarbaijan
Postal code
5981944451
Phone
+98 44 4632 1250
Email
Rasoul.2828@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
rasoul mohammadian
Position
master of science student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
10th alley, resalat street, shahindezh
City
shahindezh
Province
West Azarbaijan
Postal code
5981944451
Phone
+98 44 4632 1250
Email
rasoul.2828@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available