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
1)Determining the effect of emotion regulation therapy on quality of life compared to cognitive behavioral therapy
2)Determining the effect of emotion regulation therapy on coping methods compared to cognitive behavioral therapy
3)Determining the effect of emotion regulation therapy on treatment compliance compared to cognitive behavioral therapy
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 90 patients receiving dialysis.
Settings and conduct
The experiment will be done on dialysis patients in Khurshid Hospital. People will be randomly placed in 3 groups. 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.
Participants/Inclusion and exclusion criteria
Including:
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
Excluding:
Participating in other treatment programs at the same time
Severe physical problems
Hospitalization
Intervention groups
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
Main outcome variables
Compliance, Quality of life, Coping strategy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230119057155N1
Registration date:2023-02-16, 1401/11/27
Registration timing:prospective
Last update:2023-02-16, 1401/11/27
Update count:2
Registration date
2023-02-16, 1401/11/27
Registrant information
Name
seyedeh hanieh salimi arshad moghaddam pishkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4432 9865
Email address
haniyehsalimi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-24, 1401/12/05
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Comparison of the effect of emotion regulation therapy and cognitive behavioral therapy on patients referred to dialysis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
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
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the method of selecting people will be simple random sampling. In this way, we number the list of names of the patients who are going to enter the study from 1 to the last (90) and record each of the numbers on similar and identical small cards. Then we put all the cards in a box and every time after shaking the box, we randomly take out one card from the box and record its number. We will continue this process until the number of 30 people is obtained. We put these people in the emotion regulation treatment group. Then, after shaking the box, we take out another 30 cards and record its number. The names of the 30 cards removed will be considered as the cognitive-behavioral treatment group, and the names of the 30 cards remaining in the box will be considered as the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who is in charge of data analysis is unaware of the intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethic committee of isfahan university of medical science
Street address
hezar harib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-12-15, 1401/09/24
Ethics committee reference number
IR.MUI.MED.REC.1401.331
Health conditions studied
1
Description of health condition studied
Dialysis patients
ICD-10 code
Y84.1
ICD-10 code description
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
Description
Kidney Disease and Quality of Life
Timepoint
Before the start of the intervention - after the end of the intervention - 1 month after the intervention
Method of measurement
Kidney Disease and Quality of Life (KDQOL-SF™ 1.3)
2
Description
Adherence
Timepoint
Before the start of the intervention - after the end of the intervention - 1 month after the intervention
Method of measurement
The End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ)
3
Description
Coping strategy
Timepoint
Before the start of the intervention - after the end of the intervention - 1 month after the intervention
Method of measurement
Brief Cope Inventory ( carver)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group, people will receive emotion regulation therapy during 8 sessions in a group setting. The first session: The group members will get to know each other 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.
Category
Behavior
2
Description
Intervention group: The second group will receive cognitive-behavioral therapy during 8 sessions of 90 minutes in a group for 1 month. The first session: people will get to know each other and the goals of cognitive behavioral therapy will be explained by the therapist. They are in creation and behavior. The third session: continuing to work with automatically thoughts and the effects it has on thoughts and emotions. The fourth session: Getting to know the ABCD model and its principles. The fifth session: developing awareness of the underlying beliefs, evaluating and examining the downward arrow of the patient in real life situations. The sixth session: teaching social skills and problem solving, correcting the underlying beliefs and creating the patient's intellectual flexibility in the situation using metaphors and questioning irrational beliefs in the Socratic way. Seventh session: identifying more unconditional and core beliefs, weakening unconditional beliefs through testing evidence against conditional beliefs and questioning them in the Socratic way. Eighth session: Continuing to produce and develop alternative positive beliefs through: developing social and communication skills, developing problem-solving skills and courageous behaviors, grading alternative thoughts and determining one's place on the scale of grading alternative thoughts and determining one's place on the grading scale Self-esteem, gathering evidence for adaptive beliefs and preparing to apply learned methods in future life situations.
Category
Behavior
3
Description
Control group: In the third group, people do not receive any intervention.
What processes are involved for a request to access data/document
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.