Protocol summary
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Study aim
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Determining the effect of cognitive-behavioral therapy on hope and fear of death in patients under hemodialysis
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Design
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In this randomized clinical trial, 84 included patients under hemodialysis, will be allocated into two groups of intervention and control, using stratified-block randomization sampling method.
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Settings and conduct
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84 included patients under hemodialysis, referring to hemodialysis centers in Ilam, will be allocated into two groups of intervention and control.
At the beginning of the study, all subjects of the two groups will be asked to complete the research questionnaires including: demographic information, Herth's hope questionnaire, and the Templer's death anxiety scale. Then, for the intervention group, the cognitive-behavioral therapies will be performed in eight one-hour weekly sessions. The control group would not receive any intervention from the researcher. After completing the intervention, Herth's and Templer's questionnaires will be completed for both group and the results will be compared with each other.
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Participants/Inclusion and exclusion criteria
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Entry conditions: being alert; under hemodialysis; willingness to participate in the study
No entry conditions: history of known mental disorders; history of taking any kind of psychiatric medication; history of unsuccessful kidney transplantation
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Intervention groups
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Intervention group: receiving cognitive-behavioral therapy for eight one-hour weekly sessions
Control group: does not receive any intervention from the researcher
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Main outcome variables
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Fear of death; hope
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170514033961N3
Registration date:
2018-01-08, 1396/10/18
Registration timing:
registered_while_recruiting
Last update:
2018-01-08, 1396/10/18
Update count:
1
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Registration date
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2018-01-08, 1396/10/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research and technology, Lorestan University of Medical Sciences
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Expected recruitment start date
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2017-10-23, 1396/08/01
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Expected recruitment end date
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2018-01-21, 1396/11/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effectiveness of cognitive-behavioral therapy intervention on hope and fear of death in patients under hemodialysis
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Public title
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The effect of cognitive-behavioral therapy on hope and fear of death
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
would be under hemodialysis treatment and would be willinig to participate in the study
would be alert
Exclusion criteria:
Have a history of taking any kind of psychiatric medication
Have a history of known mental disorders such as mental retardation, Alzheimer's disease, depression, psychosis, suicidal thoughts or history of suicide attempt
Have a history of unsuccessful kidney transplantation
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Samples with inclusion criteria based on stratified-block randomization will be allocated into two groups of intervention group (cognitive-behavioral therapy) and control group (without any additional intervention by researcher)
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-09-11, 1396/06/20
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Ethics committee reference number
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LUMS.REC.1396.299
Health conditions studied
1
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Description of health condition studied
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End Stage Renal Disease
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ICD-10 code
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N18.5
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ICD-10 code description
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Chronic kidney disease, stage 5
Primary outcomes
1
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Description
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Fear of death score in Templar’s death anxiety scale
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Timepoint
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At the beginning of the study (before the intervention) and one week after the completion of cognitive-behavioral therapy sessions
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Method of measurement
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Templar’s death anxiety scale
2
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Description
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Hope score in Herth’s hope questionnaire
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Timepoint
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At the beginning of the study (before the intervention) and one week after the completion of cognitive-behavioral therapy sessions
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Method of measurement
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Herth’s hope questionnaire
Intervention groups
1
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Description
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Intervention group: This group, after completion of the research questionnaires, will receive cognitive-behavioral therapies for eight sessions, one hour per week and then will complete the questionnaires one week after the intervention.
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Category
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Rehabilitation
2
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Description
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Control group: Individuals in this group would not receive any intervention from the researcher and they only will complete the research questionnaires at the beginning and end of the research
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Khoram-Abad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The total potential data will be published after unidentifying individuals in the form of information about the main outcomes.
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When the data will become available and for how long
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Access period will start since 2018
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To whom data/document is available
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All researchers, teachers, and medical students can receive the published article from the relevant journal
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Under which criteria data/document could be used
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Undisclosed data will be available to health science researchers for meta-analysis.
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From where data/document is obtainable
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Send email to Mandana Saki
mandana_saki@yahoo.com
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What processes are involved for a request to access data/document
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After submitting the document by applicant researcher through email, the data will be sent two weeks later.
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Comments
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