The effect of cognitive-behavioral based education in comparison with conventional education on the depression , adjustment and self-care behaviors in patients with depression and heart failure hospitalized in Zahedan instructional hospitals in 2018
Determining the Effect of Cognitive-Behavioral Education in Comparison with Normal Training on Depression, Adaptation and Self-care Behaviors of Depressed Heart Disease Patients Admitted to Zahedan Educational Hospitals in 1397
Design
Clinical trial with two groups of regular education and cognitive-behavioral teaching, factorial, single-blind, simple random
Settings and conduct
Educational hospitals in Zahedan, Iran - Selection of patients by available sampling method and then their non-randomization divided into two groups: regular education and cognitive-behavioral education
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Definitive diagnosis of heart failure (Grades 2 and 3) based on cardiology and recorded in patient records
Not being infected with other known psychiatric illnesses
- Obtain a score of at least 21 from the Beck Depression Test and confirm the depression in the psychiatric examination.
- Resident of the city and accessible for follow up.
- Awareness and full awareness and ability to communicate.
-No addiction and substance abuse
- Lack of experience in rehabilitation, counseling or training programs at the same time.
-Delay at least 6 months of illness
No lack of communication
Exit criteria:
- Critical illness, death, or any unplanned event during the study;
- Clearance earlier than a week. Absence or absence of more than one treatment session.
Intervention groups
Regular training group and cognitive-behavioral group. Because of the usual training, an intervention is considered. The group's follow-up is considered as intervention.
Main outcome variables
Depression; Adaptation to disease; Self-care behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160924029954N9
Registration date:2018-08-25, 1397/06/03
Registration timing:registered_while_recruiting
Last update:2018-08-25, 1397/06/03
Update count:0
Registration date
2018-08-25, 1397/06/03
Registrant information
Name
Ali navidian
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
alinavidian@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive-behavioral based education in comparison with conventional education on the depression , adjustment and self-care behaviors in patients with depression and heart failure hospitalized in Zahedan instructional hospitals in 2018
Public title
The effect of cognitive-behavioral based education in comparison with conventional education on the depression , adjustment and self-care behaviors in patients with depression and heart failure hospitalized in Zahedan instructional hospitals in 2018
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of heart failure (Grades 2 and 3) based on cardiology and recorded in patient records
Not being infected with other known psychiatric illnesses
- Obtain a score of at least 21 from the Beck Depression Test and confirm the depression in the psychiatric examination.
- Resident of the city and accessible for follow up.
- Awareness and full awareness and ability to communicate.
-No addiction and substance abuse
-No addiction and substance abuse
-Delay at least 6 months of illness
No lack of communication
Exclusion criteria:
- Critical illness, death, or any unplanned event during the study;-
Clearance earlier than a week. Absence or absence of more than one treatment session.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
First of all, from patients with heart failure diagnosis based on the criteria for entering the study, a sample is selected according to the sampling method. We ask patients to choose a sheet from a bag contains 80 sheets. 40 sheets in blue represent the usual training group, 40 sheets in red represent the cognitive-behavioral group. People who select the red card will be in the cognitive-behavioral group and those who choose the blue tab will be placed in the regular training group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
does not have
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Zahedan University Of Medical Sciences & Health Services
Street address
Administrative Complex Of Zahedan Medical Science Campus، Persian Gulf Blvd، Dr. Hesabi Square، Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IR.ZAUMS.REC.1397.175
Health conditions studied
1
Description of health condition studied
heart failure patients
ICD-10 code
I50
ICD-10 code description
Heart failure
2
Description of health condition studied
depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
"The percentage of people who have a backseat score of over 21."
Timepoint
"Measuring depression at the beginning of the study and 30 days after intervention"
Method of measurement
Beck Depression Inventory
2
Description
"Compliance Score in the Compliance with the Disease Questionnaire"
Timepoint
"Measuring compliance at the beginning of the study and 30 days after intervention"
Method of measurement
"PAIS Compliance Inventory"
3
Description
"Self-care score in self-care questionnaire in cardiac patients"
Timepoint
"Self-care measurements before and 30 days after intervention"
Method of measurement
Self-care Questionnaire for Heart Patients
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group ": Cognitive-behavioral group, 5 separate sessions take an average of 60 minutes on the patient's bedside. Contents of the sessions: Session 1: Life with heart failure: Knowledge transfer about heart failure, signs and symptoms of symptoms, care and treatment. Session 2: Depression and Cardiac Failure: Includes a summary of the contents of the previous session, knowledge transfer about the identification of depression, the relationship between depression and heart failure, identifying concerns about depression and how to treat depression. Session 3: Behavioral Activation: Provide a brief overview of the contents of the previous session, the relationship of behavior, thoughts and creations, identifying the automatic thoughts, behavioral assessment, behavioral training, and preparing a favorite behavior table. Session 4: Solving Collaboration Problems: Provide a brief overview of the contents of the previous session, identify and understand the patient from problems, problem-solving training and problem-solving in a constructive manner, problem solving practice. Session 5: Spiritual Evolution and Aggregation: Specifies a summary of the content of the previous session, cognitive rehabilitation, self-esteem, a checklist for dealing with potential obstacles.
Category
N/A
2
Description
"Control group": routine training,4 separate sessions are held on the patient's bedside for an average of 30 minutes. The sessions include: Session 1: definitions of deficiency, causes and symptoms and symptoms of the disease. Session 2: A summary of the contents of the previous session, the importance of self-care, diet, weight control, rest and activity, measurement of urine volume. Session 3: Provide a brief overview of the contents of the meeting, monitoring signs of worsening and necessary measures, vaccination, alcohol and tobacco restrictions, the importance of taking medication. Session 4: Provide a brief overview of the content of the previous session, short video presentation, questions and answers on the topics discussed and the conclusions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Aliebn Abitaleb Hospital
Full name of responsible person
Reyhane Khayati
Street address
Healthblvd ، Persian Golf Blvd ، Zahedan ، Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813797396
Phone
+98 54 3321 1531
Email
khayati.rkh@gmail.com
2
Recruitment center
Name of recruitment center
Khatamolanbia Hospital، Zahedan ، Iran
Full name of responsible person
Reyhane Khayati
Street address
Jam Jam BLVDL ، Educational Hospital in Zahedan، Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813797396
Phone
+98 54 3321 1531
Email
khayati.rkh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Normohamad Bakhshani
Street address
Dr Hesabi Square, Zahedan،Vice Chancellorfor Research And Technology Overs Universityof Medical Sciences Zahedan، Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Reyhane Khayati
Position
Master Student Of Pychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zahedan Hermand street2
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813797396
Phone
+98 215922023
Email
khayati.rkh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Navidian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Field Of Fame - Zahedan Nursing And Midwifery Faculty
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
alinavidian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Navidian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashahir Street Univercity Of Nursing - Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2481
Email
alinavidian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participants information is confidential
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
the method of implementation of the plan is explained in the thesis
When the data will become available and for how long
The post-graduation study protocol is described in the thesis
To whom data/document is available
The analysis is done in the dissertation.
Under which criteria data/document could be used
There is no plan to publish it
From where data/document is obtainable
The thesis is explained
What processes are involved for a request to access data/document