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The effect of Cognitive Behavioral Therapy (CBT) on mental health and happiness in hemodialysis patients.

Protocol summary

Study aim
Determination and comparison of mean happiness score before and after cognitive behavioral therapy interventions in intervention group and control group . Determining and comparing the mean score of mental health before and after cognitive behavioral therapy interventions in the intervention group and the control group.
Design
A clinical trial with two groups of intervention and control group, selecting samples based on non-phase block random sampling on 40 patients.
Settings and conduct
The interventions will be randomly selected on 40 patients in Farabi Bastak Hospital Hemodialysis Center. Related training by a trained researcher for the intervention group will be presented in 8 weekly sessions, each session of 90 minutes. The control group receives routine care.
Participants/Inclusion and exclusion criteria
Inclusion Criteria Men and women range in age from 18 to 65 years. Minimum cycle literacy. 3 months from the beginning of hemodialysis and 2 to 3 sessions per week and 4 hours per session under hemodialysis. Exclusion Criteria have a history of hospitalization due to mental health problems.
Intervention groups
Interventions include cognitive behavioral therapy .In order to improve the effectiveness of this treatment on mental health and happiness of hemodialysis patients. According to the protocols related to the intervention group, patients will be trained in 8 weekly sessions and each session for 90 minutes and patients will be asked for assignments. The goal of treatment will be to change behavior. The control group receives routine services of hemodialysis center during the study period and there will be no intervention on this group.
Main outcome variables
The mental health score in keyes mental health questionnaire consisted of 14 questions. The happiness score in the Oxford Happiness Questionnaire, designed by Argyle and Lou, has 29 questions.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200915048729N1
Registration date: 2020-09-27, 1399/07/06
Registration timing: prospective

Last update: 2020-09-27, 1399/07/06
Update count: 0
Registration date
2020-09-27, 1399/07/06
Registrant information
Name
Faeqheh Paravar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 4432 2693
Email address
paravar.faeqheh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cognitive Behavioral Therapy (CBT) on mental health and happiness in hemodialysis patients.
Public title
Impact of Cognitive Behavioral Therapy (CBT) on hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least 3 months have passed since the onset of hemodialysis. No use of psychological drugs by patients. Patients undergo hemodialysis for 2 or 3 weekly sessions and each session for 4 hours.
Exclusion criteria:
Patients have a history of hospitalization due to psychological problems.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly divided into two groups of intervention and control group, each group will be 20 patiennts. The subjects were randomly divided into two groups of intervention and control. Letter A is assigned to the samples of intervention group and letter B to the samples of the control group, In this method, six modes of AABB, BBAA, BABA, ABBA, BAAB and ABAB are written in separate worksheets and placed inside a container. Then go to Randomly take one of the sheets out of the container, assuming ABAB. We put the first patients in Group A, the second in Group B, the third in Group A, and the fourth in Group B, and this leaf. And that's why, based on these six modes, 24 patients are selected and entered into groups. We repeat this method until 40 patients are selected. Since the sample size in this study is 40 patients, this operation is repeated twice.
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 Arak University of Medical Sciences
Street address
Enghelab
City
Bastak
Province
Hormozgan
Postal code
7961613153
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.ARAKMU.REC.1399.024

Health conditions studied

1

Description of health condition studied
Coronic Kidny Diseass
ICD-10 code
I12.0
ICD-10 code description
Hypertensive chronic kidney disease with stage 5 chronic kidney disease or end stage renal disease

Primary outcomes

1

Description
Mental health score in Keyes ' mental health questionnaire
Timepoint
Measuring mental health questionnaire before intervention in the intervention group,then 8 weekly sessions of cognitive behavioral therapy training، and re-measurement of mental health questionnaire in the intervention group.
Method of measurement
Keys Mental Health Questionnaire

2

Description
Happiness Score in Oxford Happiness Questionnaire
Timepoint
Measuring Oxford Happiness Questionnaire before intervention inintervention group،then 8 weekly sessions of cognitive behavioral therapy training, and again, the questionnaire of happiness in the intervention group.
Method of measurement
Oxford Happiness Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This study is an interventional clinical trial with the intervention and control groups that will be done by random sampling on 40 patients referred to Farabi Bastak Hospital Hemodialysis Center. Patients will be entered into the study after completing the consent form. Patients will be randomly divided into two groups of intervention and control group. 20 patients will be placed in each group. At first, patients will complete the Oxford Mental Health and Happiness Questionnaire before they begin their interventions. Then, cognitive Behavioral Therapy interventions will be taught to the intervention group in 8 weekly sessions and 90 minutes per session according to the protocols of this treatment by the trained person. Sessions are briefly included: valuable progressive muscle relaxation, familiarity with stress and stressors, familiarity with self-control strategies, substitution of negative thoughts with positive thoughts, familiarity with different types of cognitive errors (thinking mistakes), familiarity with a variety of assertive behaviors, familiarity with strategies to increase self-esteem, and familiarity with skills strategies. After all the sessions, both questionnaires will be completed by the patients again. Data will be analyzed using spss software. The data will be analyzed using spss software.
Category
Behavior

2

Description
Control group: he control group in the study will be a group with 20 patients after random selection. At first, both keyes mental health questionnaire and Oxford happiness questionnaire will be completed by the members of the group. During the study period, no training or intervention will be done on this group and will receive routine services of hemodialysis center. After 8 weeks, they will again complete the mental health and happiness questionnaires. The results obtained by this group will be analyzed using spss software, and according to the objectives of the study, it will be discussed and concluded.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Faegheh Paravar
Street address
Enghelab Street
City
Bastak
Province
Hormozgan
Postal code
7961613153
Phone
+98 76 4432 2693
Email
paravar.faeqheh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Enghelab
City
Bastak
Province
Hormozgan
Postal code
7961613153
Phone
+98 76 4432 2693
Email
paravar.faeqheh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Faeqheh Paravar
Position
graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Enghelab
City
Bastak
Province
Hormozgan
Postal code
7961613153
Phone
+98 76 4432 2693
Email
paravar.faeqheh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Faeqheh Paravar
Position
graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Enghelab
City
Bastak
Province
Hormozgan
Postal code
7961613153
Phone
+98 76 4432 2693
Email
paravar.faeqheh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Faeqheh Paravar
Position
graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Enqhelab
City
Bastak
Province
Hormozgan
Postal code
7961613153
Phone
+98 76 4432 2693
Fax
Email
paravar.faeqheh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the end of the study the data files and individual data files including age , sex , duration of hemodialysis and … ) patients can be shared after non recognizable.
When the data will become available and for how long
After the end of the study , the release of documents / data files The release of the data file (access to information mental health questionnaire and happiness questionnaire) is published six months after the publication of the published results.
To whom data/document is available
After the end of the study , the documentation is permitted for all those interested in the study.
Under which criteria data/document could be used
After the end of the study, the use of data or study documents to use in other studies is provided as the source of the study.
From where data/document is obtainable
in order to obtain the documentation,Faeqheh Paravar, with the postal address of province Hormozgan, Bastak City, Enghelab street Send mail to paravar.faeq @ gmail. com send Watsapp No. 09184872690 to Faeqheh paravar
What processes are involved for a request to access data/document
people interested in receiving study documentation, can send their request to me The request will usually be answered in the shortest possible time, usually 2 hours. paravar.faeqheh@gmail.com The text of the request will be sent to whatsapp number 09184872690.
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