The aim of this study was to evaluate the impact of cognitive therapy on psychological health and quality of life in patients with heart failure . Randomized double -blind controlled study was performed with usual care in heart failure . Patients with brain problems including stroke and transient cerebral attacks or severe depression have been deleted from the study . Prior research tools used in the study of mental health and quality of life were completed by Minnesota mental quality of life for these patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204304655N2
Registration date:2014-02-24, 1392/12/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-24, 1392/12/05
Registrant information
Name
Mohsen Taghadosi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
taghadosi_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University Of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cognitive Therapy Effect in Mental Health And Quality Of Life In Patients With Heart Failure
Public title
Cognitive Therapy Effect In Treatment Of Heart Failure
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: Age over 21 years; EF less than 40% ; at least 2 months have passed since the diagnosis and treatment of diseases are able to speak and understand Farsi or Persian language must already be receiving training in cognitive therapy.
Exclusion criteria: History of neurological problems ( such as Alzheimer's disease - stroke - transient cerebral attack ); have no end- stage heart failure patients may not.
Age
From 21 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
kashan university of medical science
Street address
Ravandi Ghotb Blvd، Kashan University of Medical Sciences
City
kashan
Postal code
Approval date
2012-11-12, 1391/08/22
Ethics committee reference number
3139/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Heart faillure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Mental health
Timepoint
Preintervention and one month post start intervention
Method of measurement
General health questionarry
Secondary outcomes
1
Description
Quality of life
Timepoint
Preintervention and one month post start intervention
Method of measurement
Quality of life minnesota questionnary
Intervention groups
1
Description
This is a clinical trial study that performed on 60 patients with heart failure in Beheshti hospital of KAUMS (2012). Sampling was based on objective and then patients randomized in two groups. The experimental group in 1 month received 8 sessions of cognitive therapy and control group only underwent heart usual care. Data collected using the Goldberg Health Questionnaire and Minnesota quality of life questionnaire analyzed by statistical tests (Exact Fisher, independent t-test, pair t-test).
Category
Behavior
2
Description
The control group only do general intervention in heart failure
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan University Of Medical Science, Beheshti Hospital
Full name of responsible person
Street address
City
kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
kashan medical university
Full name of responsible person
hamidi gholamali
Street address
kashan
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
kashan medical university
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
Department, Kashan University of Medical Sciences
Full name of responsible person
Taghadosi mohsen
Position
PhD student director of journal pheyz
Other areas of specialty/work
Street address
kashan
City
kashan
Postal code
87159/81151
Phone
+98 36 1555 0021
Fax
+98 36 1555 6633
Email
taghadosi.m@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan university medical science
Full name of responsible person
Mohsen Taghadosi
Position
PhD Candidat
Other areas of specialty/work
Street address
iran
City
kashan
Postal code
87159/81151
Phone
+98 36 1555 0021
Fax
Email
taghadosi_m@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Taghadosi mohsen
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)