Protocol summary
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Study aim
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Determining the impact of emotion regulation therapy on quality of life, treatment compliance and coping strategy compared to cognitive behavioral therapy in dialysis patients.
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Design
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Clinical trial with control group, with parallel groups, double-blind, simple randomization method, on 90 patients receiving dialysis.
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Settings and conduct
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The experiment will be conducted on dialysis patients in Khurshid and Amin Hospital of Isfahan province. People will be randomly divided into 3 groups. People participating in the intervention groups will receive individual cognitive behavioral therapy and emotion regulation in 8 weekly sessions (2 months). The therapist will be unaware of the outcome variables. The person who evaluates the outcome variables will be unaware of the objectives and hypotheses of the study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Referral of a nephrologist with the diagnosis of the need for dialysis
No serious psychiatric illness
No substance abuse or addiction
Having at least a cycle degree
Fill out the informed consent form
Being between 20 and 60 years old
Exclusion criteria:
Participating in other treatment programs at the same time
Severe physical problems
Hospitalization
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Intervention groups
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The first intervention group receives emotion regulation therapy in 8 sessions as a group. The second intervention group will receive cognitive-behavioral therapy in 8 sessions as a group, and the third group is the control group
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Main outcome variables
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Compliance, Quality of life, Coping strategy
General information
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Reason for update
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During the implementation, we realized that dialysis patients do not want to participate in group treatment (due to frequent visits to the hospital). A hospital is not able to cover all the required samples. Randomization and blinding have also been changed in consultation with the project manager and statistical consultant.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230119057155N1
Registration date:
2023-02-16, 1401/11/27
Registration timing:
prospective
Last update:
2025-02-15, 1403/11/27
Update count:
2
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Registration date
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2023-02-16, 1401/11/27
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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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Expected recruitment start date
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2023-02-24, 1401/12/05
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Expected recruitment end date
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2023-03-11, 1401/12/20
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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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Comparison of the effect of emotion regulation therapy and cognitive behavioral therapy on quality of life, adherence and coping strategy of patients referred to dialysis
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Public title
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Comparison of the effect of emotion regulation therapy and cognitive behavioral therapy on patients referred to dialysis
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Referral of a nephrologist with the diagnosis of the need for dialysis
No serious psychiatric illness
No substance abuse or addiction
Having at least a cycle degree
Fill out the informed consent form
Being between 20 and 85 years old
Exclusion criteria:
Participating in other treatment programs at the same time
Severe physical problems
Hospitalization
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Age
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From 20 years old to 85 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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- Care provider
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The randomization of this study will be done using the simple randomization method in order to randomly assign patients to each group. For this purpose, we use WWW.research randomizer.com. Finally, we will have a list where the letter in front of each number indicates which group the person belongs to.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The person who is in charge of data analysis is unaware of the intervention groups.
The person providing the treatment is unaware of the outcome variables.
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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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2022-12-15, 1401/09/24
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Ethics committee reference number
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IR.MUI.MED.REC.1401.331
Health conditions studied
1
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Description of health condition studied
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Dialysis patients
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ICD-10 code
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Y84.1
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ICD-10 code description
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Kidney dialysis as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
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Description
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Quality of Life in dialysis patients
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Timepoint
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Before the start of the intervention - after the end of the intervention - 3 month after the intervention
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Method of measurement
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Quality of life questionnaire in dialysis patients
2
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Description
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Adherence to treatment
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Timepoint
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Before the start of the intervention - after the end of the intervention - 3 month after the intervention
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Method of measurement
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The End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ)
3
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Description
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Coping strategy
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Timepoint
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Before the start of the intervention - after the end of the intervention - 3 month after the intervention
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Method of measurement
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Brief Cope Inventory ( carver)
Intervention groups
1
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Description
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Intervention group 1:people will receive emotion regulation therapy during 8 sessions of 1 hour individually over 2 months. The first session: Patient assessment and the treatment goals will be set and the intervention steps will be explained. The second session: People will be given emotional training and emotion-provoking situations will be given through teaching the difference in the performance of different types of emotions. The third session: We evaluate the vulnerability of the members and their emotional skills. The fourth session: Making changes in situations that provoke excitement. The fifth session: The goal is to change attention and stop rumination and train attention. The sixth session: changing cognitive evaluations and identifying wrong evaluations and their effects on emotional states. Seventh session: The goal is to change the behavioral and physiological consequences of emotion. Eighth session: Re-evaluate and remove barriers to application.
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Category
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Behavior
2
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Description
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Intervention group 2: The second group will receive cognitive-behavioral therapy during 8 sessions of 1 hour individually over 2 months. the first session: The therapist will explain the patient's attitude to change and the goals of cognitive behavioral therapy. The second session: We will explain the similarities and differences between depression and medical illness to the patients. Third to fifth sessions: work with ineffective thoughts and teach the use of behavioral activation techniques and the relationship between ineffective automatic thoughts and perceptions and negative consequences. The sixth session: teaching and practicing healthy life skills (adaptation) in the session. Session 5: Session 7: Increase positive social interactions - Initiate contact, create a support network Session 8: Plan for termination of treatment Determine which interventions were helpful and which were not, relapse prevention, gathering evidence for adaptive beliefs and preparing to apply the learned methods in future life situations.
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Category
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Behavior
3
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Description
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Control group: people do not receive any intervention.
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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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No
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Title of funding source
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Isfahan university of medical of science
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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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All participant data can be shared after de-identification.
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When the data will become available and for how long
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The access period starts 6 months after the results are published
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Providing the data is only for better understanding of the method of this research. Therefore, analysis on the data is not possible.
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From where data/document is obtainable
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haniehsalimi:haniyehsalimi@resident.mui.ac --salimimobina120@mail.com
Phone:00989113875663
Fatemeh zargar:fatemehzargar@gmail.com
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What processes are involved for a request to access data/document
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First, send an email to Mrs. Haniyeh Salimi. If you do not receive an answer from the university email, send a message to your personal email. Otherwise, send a message to Dr. Fatemeh Zargar email. We try to respond within a week.
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Comments
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