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The Effectiveness of Mindfulness Integrated Cognitive behavioral Therapy (MiCBT) on the Negative Emotions, improvement of executive function, Emotion Regulation and change of quantitative electroencephalography waves (QEEG) of patients with Multiple Sclerosis

Protocol summary

Study aim
This study aims to determine the effect of mindfulness training on improving negative emotions, improving executive function, improving cognitive emotional regulation and changing quantitative electroencephalography (QEEG) waves of patients with multiple sclerosis.
Design
The clinical trial has 26 people in the intervention group and 26 people in the control group. It was calculated with Gpower software, with parallel, unblinded, randomized groups.
Settings and conduct
Brain and Neurological Diseases Research Center and Shafa Hospital affiliated to Kerman University of Medical Sciences, Iran
Participants/Inclusion and exclusion criteria
Entering the study is informed consent, having an official diagnosis of MS, women and men 20-50 years old, at least a diploma, right superior and taking beta interferon medication, and exiting the study is suffering from other psychiatric and neurological disorders and taking epilepsy medication and etc
Intervention groups
The intervention group will receive 8 sessions of mindfulness-based cognitive behavioral therapy, MiCBT Kayon 2011, and the control group: the control group will not receive any intervention during the research.
Main outcome variables
Negative emotional states with the DASS21 questionnaire made by Lovibond(1995), emotion regulation with the CERQ questionnaire of Garnefski & Kraaij, executive function with the EFQ questionnaire of Tos Nejati (2013), quantitative electroencephalography waves with brain maps.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230212057396N1
Registration date: 2023-11-25, 1402/09/04
Registration timing: prospective

Last update: 2023-11-25, 1402/09/04
Update count: 0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
atefeh fakhrmand
Name of organization / entity
The University of alzahra tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 4040
Email address
a.fakhrmand@alzahra.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-31, 1402/10/10
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Mindfulness Integrated Cognitive behavioral Therapy (MiCBT) on the Negative Emotions, improvement of executive function, Emotion Regulation and change of quantitative electroencephalography waves (QEEG) of patients with Multiple Sclerosis
Public title
The Effectiveness of Mindfulness Integrated Cognitive behavioral Therapy (MiCBT) on the Negative Emotions, improvement of executive function, Emotion Regulation and change of quantitative electroencephalography waves (QEEG) of patients with Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The criteria for entering the study are all MS patients with an official diagnosis of MS There are men and women with an age range of 20-50 years. They have at least a diploma. The right is superior. They take beta interferon medicine. All patients completed an informed consent form.
Exclusion criteria:
Conditions for not entering the study:MS patients suffer from other psychiatric and neurological disorders. MS patients consumed alcohol or drugs at least two weeks before the study. MS patients received psychological treatment near the study MS patients have epilepsy. They have a history of seizures, brain trauma and other structural brain diseases.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
More than 1 sample in each individual
Number of samples in each individual: 26
MS patients under the supervision of a neurologist at Shafa Kerman Hospital will be selected in 2 groups of 26 people with a definite diagnosis of MS with a disability coefficient below 6, the first group will be the intervention group and the second group will be considered the control group. became. The sample size was calculated with Jpower software, for this purpose, in this research, the sample size is selected for each group of 26 people, and the disturbing variables affecting the dependent variable, through the peers of the two groups, in the characteristics that influence the independent variable of the disturbing intervention. We match. In this research, the criteria for entering the study, both groups having informed consent, having an official diagnosis of MS based on the modified McDonald's criteria in 2017 (Mantro, Abit, Balgra et al., 2018), women and men with an age range of 50 - 20 years old, the educational qualification is at least a diploma, right superior, and the use of beta interferon drug, and the exclusion criteria are suffering from other psychiatric and neurological disorders based on medical references and the opinion of a neurologist, a member of the faculty of Kerman University of Medical Sciences. is used, consumption of alcohol or drugs for at least two weeks before the research, receiving any psychological treatment, having epilepsy and history of seizures - taking epilepsy drugs of any name, for example gabapentin for pain relief, taking sleeping pills and barbiturates, history Brain trauma and other structural brain diseases. Before starting the research, the diagnostic interview and DSM5 diagnostic and statistical guide criteria of mental disorders will be used to diagnose the mental disorders of the groups. Participants are randomly assigned to intervention and control groups.
Randomization (investigator's opinion)
Randomized
Randomization description
After reviewing and confirming the criteria for entering and exiting the study, MS patients will be placed in two intervention and control groups of 26 people, so that the names of 26 people who are selected in the lottery will be placed in the intervention group and The rest will be in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The present research is a semi-experimental design with pre-test and post-test with the control group.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kerman University of Medical Sciences, Iran
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-10-30, 1402/08/08
Ethics committee reference number
IR.KMU.REC.1402.300

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

2

Description of health condition studied
Negative Emotional States
ICD-10 code
R45
ICD-10 code description
Symptoms and signs involving emotional state

3

Description of health condition studied
Executive Functions
ICD-10 code
ICD-10 code description

4

Description of health condition studied
Quantitative Electroencephalographic Waves
ICD-10 code
R94.0
ICD-10 code description
Abnormal results of function studies of central nervous system

5

Description of health condition studied
Emotion Regulation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Negative Emotional States
Timepoint
Emotional states will be measured once before the implementation of the intervention in the first session (pre-test) and once in the last session after the intervention.
Method of measurement
In order to examine emotional states, the original version of DASS has 42 questions, but later it was shortened and reduced to 21 questions. This questionnaire has 21 items including 8 items related to depression (D), 7 items related to anxiety (A) and 6 items related to stress (S).

2

Description
Executive Functions
Timepoint
Executive functions will be measured once before the implementation of the intervention in the first session (pre-test) and once in the last session after the intervention.
Method of measurement
EFQ standard questionnaire of executive functions is used to check executive functions. This questionnaire was compiled by Tos Nejati (2012) and has 30 items and seven subscales. The scoring method is a 5-point Likert scale from almost never (5) to always (1). Its seven subscales include memory (1 to 6), selective attention, questions 7 to 12), decision making (questions 13 to 17), planning (questions 18 to 20), persistent memory (questions 21 to 23), social cognition. (questions 24 to 26) and cognitive flexibility (questions 27 to 30)

3

Description
Quantitative electroencephalographic waves(QEEG)
Timepoint
QEEG will be measured once before the implementation of the intervention in the first session (pre-test) and once in the last session after the intervention.
Method of measurement
An EEG device made in Iran under a Canadian license will be used to record the electroencephalogram. In this method, signals and brain waves are recorded by the electrodes on the scalp. This information is entered into the computer and converted into numbers and graphs through QEEG (quantitative brain mapping).

4

Description
Emotion Regulation
Timepoint
Cognitive emotional regulation will be measured once before the implementation of the intervention in the first session (pre-test) and once in the last session after the intervention.
Method of measurement
CERQ cognitive regulation of emotion questionnaire is used to examine the cognitive regulation of emotion. It is a self-assessment questionnaire designed by Garnevsky and Kraich. This questionnaire has 36 questions that have 9 subscales.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the participants of this group, 8 sessions of Mindfulness Integrated Cognitive behavioral Therapy MiCBT, will be implemented within the framework of the Brauno Cayoun protocol.
Category
Behavior

2

Description
Control group: At the time of conducting the research, the control group will not receive any intervention. The goal is to check whether the passage of time creates a change in these patients or not, but after the completion of the research, the participants of the control group will also receive 8 sessions of MiCBT intervention as an appreciation for conducting the research. will be executed.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Kerman Hospital
Full name of responsible person
Hoda Kamali
Street address
Iran, Kerman, Kausar Blvd., Shafa Medical Education Center
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
Hoda_3303@Yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Neurology Research Center
Full name of responsible person
Ebrahimi-meimand
Street address
Iran, Kerman, Kausar Blvd.,Neurology Research Center
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3212 4727
Email
kmu.nrc@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neurology Research Center
Proportion provided by this source
50
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
The University of Alzahra Tehran
Full name of responsible person
Atefeh Fakhrmand
Position
Phd Student in Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Alzahra University, North Sheikh Bahaee St., Deh-e Vanak, Tehran, I. R. of Iran
City
Tehran
Province
Kerman
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
+98 21 8805 8925
Email
A.Fakhrmand@Alzahra.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hoda Kamali
Position
Academic staff of Kerman University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Specialized Board of Fellowship MS Specialized Board of Fellowship MS
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
Hoda_3303@Yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The University of AlzahraTehran
Full name of responsible person
Atefeh Fakhrman
Position
PhD Student in psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Alzahra University, North Sheikh Bahaee St., Deh-e Vanak, Tehran, I. R. of Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
۹۸۲۱۸۸۰۴۴۰۴۰+
Email
A.Fakhrmand@Alzahra.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
the data are collected anonymously
When the data will become available and for how long
in case of request the data are available anonymous
To whom data/document is available
Other researchers have research plans from reputable centers
Under which criteria data/document could be used
researchers with credible studies from reputable constitutions
From where data/document is obtainable
After publication of the article to the corresponding author
What processes are involved for a request to access data/document
contact with the corresponding author
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