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IRCT20230212057396N1 IRCT 2023-11-25 Neurology Research Center 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 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 2023-12-31 anticipated 52 Complete https://irct.ir/trial/68551 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The present research is a semi-experimental design with pre-test and post-test with the control group, 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. N/A Condition 1: Multiple sclerosis. Condition 2: Negative Emotional States. Condition 3: Executive Functions. Condition 4: Quantitative Electroencephalographic Waves. Condition 5: Emotion Regulation. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: the data are collected anonymously When: in case of request the data are available anonymous To whom: Other researchers have research plans from reputable centers Conditions: researchers with credible studies from reputable constitutions Where to obtain: After publication of the article to the corresponding author How to obtain: contact with the corresponding author Comments:
public Atefeh Fakhrmand
Alzahra University, North Sheikh Bahaee St., Deh-e Vanak, Tehran, I. R. of Iran
Tehran Iran (Islamic Republic of) ۱۹۹۳۸۹۳۹۷۳ +98 21 8805 8925 A.Fakhrmand@Alzahra.ac.ir The University of Alzahra Tehran scientific Hoda Kamali
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5856 Hoda_3303@Yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) 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. 20 years 50 years Both 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. G35 R45 R94.0 Multiple sclerosis Symptoms and signs involving emotional state Abnormal results of function studies of central nervous system Behavior Behavior 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. 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. 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). 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). 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). 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. Neurology Research Center Approved 2023-10-30 Kerman University of Medical Sciences, Iran Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)