Comparison of Effectiveness of Cognitive Behavioral Therapy and Dialectic Behavioral Therapy on Medication Adherence in Patients Undergoing Hemodialysis
Comparison of the effectiveness of Cognitive Behavioral Therapy and Dialectical Behavior Therapy on adherence to drug therapy in renal hemodialysis patients.
Design
With considering dropout rate, 60 individuals will be selected as available, and we will randomly place the eligible individuals into three groups (two experimental and one control).
Settings and conduct
This study is performed on patients undergoing hemodialysis who do not follow drug treatment. The research environment of hospitals equipped with hemodialysis in Isfahan. after calling for participation in the hospital and informing the people who enter the research, they will receive individual cognitive-behavioral therapy and another group of dialectical behavioral therapy. No blinding is performed in this study
Participants/Inclusion and exclusion criteria
Patients with renal insufficiency treated with hemodialysis; Conditions for non-admission of patients with renal insufficiency who are not undergoing hemodialysis treatment and other diseases.
Intervention groups
One experimental group receives cognitive-behavioral therapy (CBT) individually for 8 sessions of 45 minutes and the other experimental group receives dialectical behavioral therapy (DBT) individually for 8 sessions of 45 minutes. The control group does not receive any medical intervention, only the questionnaire will be obtained from the control group and it is possible to receive the desired treatment on the control group after the end of the research.
Main outcome variables
Medication adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200206046394N1
Registration date:2020-07-16, 1399/04/26
Registration timing:prospective
Last update:2020-07-16, 1399/04/26
Update count:0
Registration date
2020-07-16, 1399/04/26
Registrant information
Name
Arman Mehrazin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5263 0259
Email address
armanmehrazinn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of Cognitive Behavioral Therapy and Dialectic Behavioral Therapy on Medication Adherence in Patients Undergoing Hemodialysis
Public title
Comparison of Effectiveness of Cognitive Behavioral Therapy and Dialectic Behavioral Therapy on Medication Adherence in Patients Undergoing Hemodialysis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum 18 years and maximum 60 years
Minimum diploma literacy
Ability to complete the questionnaire
Willingness to participate in the study
Hemodialysis twice or more per week
Lack of mental disability or known severe mental illness or functional (bone muscular) disability
Fully alert
Listening and speaking ability
Exclusion criteria:
With known severe mental illness or functional disability (muscle, bone)
Drug addiction
Being hospitalized in the intensive care unit
Unwillingness to participate in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sixty patients are selected in a convenient way, by providing informed consent form to the hemodialysis patients, and then patients with poor and moderate medication adherence score in the Morisky Medication Adherence Scale will be selected and we will randomly place eligible individuals into three groups (two experimental and one control). The method of assigning individuals in control and intervention groups is simple randomization and randomization tool is the lottery.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Due to the spread of the new corona virus in Iran, it is not possible to determine the exact time of onset and end of the choose a patient, so there is a possibility of a slight change in these times.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University - Isfahan Branch (Khorasgan)
Measurements of drug treatment adherence are completed before the intervention and 14 days after the start of the intervention and immediately after the intervention, and questionnaires are re-completed one month after the intervention.
Method of measurement
Morisky Medication Adherence Scale
Secondary outcomes
1
Description
Accompanying depression score
Timepoint
Before and after the intervention, the questionnaires will be completed by the subjects in order to follow up on the effect of the interventions one month after the interventions.
Method of measurement
Beck's second depression inventory
2
Description
Accompanying anxiety score
Timepoint
Before and after the intervention, the questionnaires will be completed by the subjects in order to follow up on the effect of the interventions one month after the interventions.
Method of measurement
Beck Anxiety Inventory
3
Description
Medicinal beliefs of patients or medicinal beliefs of individuals
Timepoint
Before and after the intervention, the questionnaires will be completed by the subjects in order to follow up on the effect of the interventions one month after the interventions.
Method of measurement
Questionnaire and drug belief tool for patients (BMQ), which higher scores indicate a stronger belief of patients in each of the subscales.
Intervention groups
1
Description
Control group: They do not receive any intervention.
Category
N/A
2
Description
Cognitive-behavioral intervention will be performed by embezzlement from Farquhar. Its steps include: The first step is to identify the patient's problem and the reason for the patient's non-compliance through a face-to-face interview. (Questions such as: Why don't you follow your medication regimen? What is the biggest obstacle to your adherence to the medication regimen? ...). The second stage of the intervention is to create commitment and self-confidence in the patient in order to correct the wrong behavior. At this stage, with the help of the researcher, the patient recognizes the problems and obstacles related to his non-commitment, and at this time a contract is created between the patient and the researcher to improve compliance, which is through increasing the patient's motivation to change behavior. By saying positive affirmations, the researcher tries to increase the patient's self-confidence and create interest in changing the patient's misbehavior. At the end of the session, the patient is also asked to write down all the things he or she does during the next week and the next session as a daily report in order to follow the medication regimen throughout the day. In the second week of the third stage of the intervention, all the patient's daily reports on adherence to the medication regimen and the patient's self-reported statements are reviewed and summarized. In this way, according to the patients 'report, the obstacles and factors affecting the patients' adherence to the medication regimen are examined. In the fourth stage, the intervention of the designed program is provided to the patients face to face. This program includes training on following the medication regimen of hemodialysis patients (in the form of an educational pamphlet) and also provides patients with the necessary information about the implementation of the designed program. In the fourth week, the fifth and sixth stages of the intervention are performed, and in fact in this stage, it is evaluated to what extent the designed program is effective in improving patient compliance. It seems that this behavior is maintained through the use of motivational sentences. These steps will be followed by a structured face-to-face motivational interview in four 30-40 minute sessions.
Category
Treatment - Other
3
Description
Second intervention group: Dialectical behavioral therapy interventions are performed under the auspices of Marsha Linhan (1993), Mito McKay et al. (2007), and Melanie Gordon, Sheets (2009). Its steps include: The first session is familiar with the concept of mindfulness and three mental states (logical mind, emotional mind and mindfulness). The second session includes teaching two categories of skills to achieve mindfulness: the first category of "what" skills (including observation, description and description) and the second category of "how" skills (including non-judgmental, self-conscious and efficient self-awareness). to act, to act upon, surgery). The third step involves teaching strategies to distract and distract the mind with acceptance skills (activities, participation, comparisons, distractions, thoughts, and feelings). The fourth stage involves self-relaxation training with five senses. The fifth step involves teaching the pattern of identifying emotions and labeling them, which leads to increased emotion control. The sixth session includes training on creating positive emotional experiences by creating short-term positive emotional experiences. The seventh session includes situations for effective communication and interpersonal efficiency (proportionality of one's desires with the desires of others; the ratio of desires to needs). The eighth session includes effective communication goals and interpersonal efficiency (achieving goals in a situation and coping with resistance and conflict.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr. Mehdi Nasresfahani
Street address
Sofe Boulevard
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farid Naeemi
Street address
the end of Daneshjoo Boulevard, Manzaria
City
Khomeini shahr
Province
Isfehan
Postal code
8418148499
Phone
+98 31 3366 0011
Email
site@iaukhsh.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Khomeini Shahr Branch
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
Islamic Azad University
Full name of responsible person
Arman Mehrazin
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
3rd Floor, Block 319, Parking 3, Neighborhood A3., Esteghlal St
City
Fooladshahr
Province
Isfehan
Postal code
84918-36489
Phone
+98 31 5263 0259
Email
armanmehrazinn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arman Mehrazin
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
3rd Floor, Block 319, Parking 3, Neighborhood A3, Esteghlal St
City
Fooladshahr
Province
Isfehan
Postal code
84918-36489
Phone
+98 31 5263 0259
Email
armanmehrazinn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arman Mehrazin
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
3rd Floor, Blocck 319, Parking 3, Neighborhood A3, Esteghlal St
City
ّFooladshahr
Province
Isfehan
Postal code
84918-36489
Phone
+98 31 5263 0259
Email
armanmehrazinn@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data of the subjects can be shared as a group after identifying the people who can share both the total data and the part of the data such as information about the main consequence or the like.
When the data will become available and for how long
Start the access period 6 months after printing the results.
To whom data/document is available
Magazines, newspapers, magazines that need these documents to publish an article.
Under which criteria data/document could be used
Under the terms and conditions of confidentiality and for the purposes of scientific progress and observance of the anonymous principles of the participants.
From where data/document is obtainable
Please refer to the first author and the author, in charge of Arman Mehrazin by e-mail armanmehrazinn@gmail.com and phone number 09384743599.
What processes are involved for a request to access data/document
Please send an email or phone number to the first author and the responsible author to receive research documents or data files. The applicant's requested documents and files will be provided to the applicant no later than one month after the applicant's application.
Comments
Given that each magazine has its own form, I don't have a specific plan at the moment.