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IRCT20230922059489N1 IRCT 2023-10-05 Ferdowsi University of Mashhad Brain function of people with depressive symptoms before and after tDCS, tPCS and cognitive rehabilitation interventions Evaluation of QEEG indicators, neuropsychological characteristics and theory of mind in subjects with depressive symptoms: comparing the effectiveness of transcranial direct current stimulation (tDCS) and transcranial pulsed current stimulation (tPCS) with cognitive rehabilitation. 2023-10-23 anticipated 60 Complete https://irct.ir/trial/72733 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the randomization of the participants, in order to balance the overall sample size and homogeneity of the main characteristics in the groups (gender and severity of depression), the minimization or matching randomization method is used based on auxiliary variables. In this method, the first participant is randomly assigned to one of the groups, and the next participants are assigned to a group with the least predetermined characteristic in that group. Randomization is done using sealed and waxed opaque envelopes. Based on the size of the research sample, a number of envelopes with aluminum foil (in order to make the contents of the envelopes unclear), preparation, and each of the random sequences created on a card are recorded and the cards are placed inside the envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box in order, Blinding description: Before starting the research process, all three intervention methods (tDCS + cognitive rehabilitation), (tPCS + cognitive rehabilitation) and (cognitive rehabilitation) and their role in reducing depression symptoms are to be explained to the participants based on past articles and researches. The purpose of this explanation is to increase the level of awareness of the participants regarding the desired interventions. Finally, after increasing the level of awareness of the participants, they are informed that one of the interventions will be applicable for them by chance, but an explanation regarding which intervention is being implemented is not given until the end of the research process. Therefore, the participants will enter the study process with their written consent. N/A The participants in this research are people who are diagnosed with symptoms of depression after conducting clinical interviews and initial evaluations by a clinical psychologist. Also, the severity of depression symptoms will be based on the Beck Depression Inventory in three ranges (minimum depression, weak depression and moderate depression).. Intervention 1: Intervention group: (Experimental group 1): tDCS is combined with cognitive rehabilitation. In this research, stimulation using the SegalStim device, through two positive and negative electrodes that are placed on the head through sponge pads soaked with conductive solution (normal saline) — in 10 consecutive sessions and each session It is applied for 20 minutes with a current of 2 milliamps. In this group, as mentioned, cognitive rehabilitation(Captain Log's) is used in the form of 10 consecutive sessions for 45 minutes in each session together with tDCS. Intervention 2: Intervention group: (Experiment group 2): tPCS is combined with cognitive rehabilitation. In this research, transcranial pulsed current stimulation is applied in 10 consecutive sessions (2 weeks) and each session lasts for 20 minutes with a current intensity of 2 milliamps with a randomly generated frequency between 6 and 10 Hz. In this group, cognitive rehabilitation (Captain Log's) is also used in 10 consecutive sessions for 45 minutes in each session along with tPCS. Intervention 3: Intervention group:(Experimental group 3): Cognitive rehabilitation (Captain Log's) alone. In this group, cognitive rehabilitation (Captain Log's) is used in 10 consecutive sessions for 45 minutes in each session. Yes - There is a plan to make this available What will be shared: At the end of the research process and statistical analysis of the data obtained from the evaluations performed for each participant, all the data without the names of the people and their personal characteristics are unidentifiable, and the data related to the main results of the study in theses and articles will be shared. When: Access to the data of this research will begin 6 months after the results are published. To whom: Researchers working in academic and scientific institutions as well as people working in an industry can send request to receive data and other study documents. Conditions: The request to receive personal non-identifiable data should be aimed at expanding the current research and advancing scientific issues. Where to obtain: Applicants can refer to the researcher of this study (Fatemeh Ghanaei Chamanabad) to receive the desired documents or data. Email address:fa.ghanaeechamanabad@um.ac.ir Farnoosh.ghanaee91@gmail.com Phone number:0098-9150528381 How to obtain: 6 months after printing the results, the request to receive documents or data files must be made. Applicants must introduce themselves and provide the necessary documents to introduce themselves as researchers working in academic and scientific institutions or industrial units. The purpose of receiving this data should also be mentioned. Comments:
public Fatemeh Ghanaei Chamanabad
No. 30, Mirza Javad Agha Tehrani Alley5th,Boostan town, Torghabeh Blvd, Mashhad, Razavi Khorasan province, IRAN
Mashhad Iran (Islamic Republic of) 9351967493 +98 51 3423 1013 fa.ghanaeechamanabad@um.ac.ir Ferdowsi University of Mashhad scientific Ali Mashhadi
Faculty of Education Sciences and Psychology, Ferdowsi University of Mashhad, Azadi Square, Mashhad
Mashhad Iran (Islamic Republic of) 9177948991 +98 51 3880 3600 mashhadi@um.ac.ir Ferdowsi University of Mashhad Iran (Islamic Republic of) Suffering from depression based on; Clinical interview and psychologist's diagnosis as well as Beck Depression Inventory Not starting to take antidepressants No history of hospitalization and mood disorder Not having anxiety disorders No psychotic symptoms Not having a history of seizures and epilepsy being right-handed Age ranges from 18 to 40 years Have at least a high school diploma The person's agreement to participate in the research based on completing the informed consent form 18 years 40 years Both The person's unwillingness to continue cooperation Absence of more than three consecutive sessions Taking antidepressants during the research process Occurrence of psychotic symptoms Occurrence of seizures and epilepsy History of hospitalization in a psychiatric hospital, psychiatric and psychological treatment at the same time as conducting research F06.30 Mood disorder due to known physiological condition, unspecified Treatment - Devices Treatment - Devices Rehabilitation Intervention group: (Experimental group 1): tDCS is combined with cognitive rehabilitation. In this research, stimulation using the SegalStim device, through two positive and negative electrodes that are placed on the head through sponge pads soaked with conductive solution (normal saline) — in 10 consecutive sessions and each session It is applied for 20 minutes with a current of 2 milliamps. In this group, as mentioned, cognitive rehabilitation(Captain Log's) is used in the form of 10 consecutive sessions for 45 minutes in each session together with tDCS. Intervention group: (Experiment group 2): tPCS is combined with cognitive rehabilitation. In this research, transcranial pulsed current stimulation is applied in 10 consecutive sessions (2 weeks) and each session lasts for 20 minutes with a current intensity of 2 milliamps with a randomly generated frequency between 6 and 10 Hz. In this group, cognitive rehabilitation (Captain Log's) is also used in 10 consecutive sessions for 45 minutes in each session along with tPCS. Intervention group:(Experimental group 3): Cognitive rehabilitation (Captain Log's) alone. In this group, cognitive rehabilitation (Captain Log's) is used in 10 consecutive sessions for 45 minutes in each session. In this research, in order to measure the symptoms of depression and better understand the changes in the level of depression symptoms before and after the desired interventions, the scores obtained in the Beck Depression Inventory (based on the severity of depression) are used. Timepoint: Evaluation and measurement of depression symptoms will be done at the beginning of the study (before the start of the intervention) and after 10 intervention sessions. Method of measurement: Beck Depression Inventory. In the present study, in order to record brain waves and better understand the changes made in QEEG indicators (three-dimensional intra-brain distributions of current density for frequency bands, power changes, frequency bandwidth and brain wave asymmetry) of people with depression symptoms, Before and after the desired interventions, visible changes in Quantitative Electroencephalography recording are used. Timepoint: QEEG indicators will be evaluated at the beginning of the study (before the intervention) and after 10 intervention sessions. Method of measurement: Quantitative Electroencephalography(QEEG). In this research, in order to measure and better understand the changes in neuropsychological characteristics (verbal working memory, visuospatial working memory, planning, set shifting (mental flexibility), inhibition and sustained attention) of people with symptoms Depression, before and after the desired interventions, the scores obtained in the computerized cognitive tests and Barkley Deficits in Executive Functioning Scale are used. Timepoint: Evaluation of neuropsychological characteristics will be done at the beginning of the study (before the start of the intervention) and after 10 intervention sessions. Method of measurement: Digit Span, Corsi Blocks Test, Tower of London Test, Wisconsin Card Sorting Test, Go/No-Go, Continuous Performance Test and Barkley Deficits in Executive Functioning Scale. In this research, in order to measure and better understand the changes made in the theory of mind of people suffering from depression symptoms, before and after the desired interventions, the scores obtained in Reading the Mind in the Eyes Test will be used. Timepoint: Theory of mind evaluation and measurement will be done at the beginning of the study (before the intervention) and after 10 intervention sessions. Method of measurement: Reading the Mind in the Eyes Test. In the present study, in order to measure and better understand the changes in the level of emotional problems of people with depressive symptoms before and after the desired interventions, from the scores obtained in Positive Affect and Negative Affect Scales(PANAS)and Multidimensional Emotional Disorder Inventory (MEDI) is used. Timepoint: Evaluation and measurement of emotional problems is done at the beginning of the study (before the start of the intervention) and after 10 sessions of the intervention. Method of measurement: Positive Affect and Negative Affect Scales(PANAS), Multidimensional Emotional Disorder Inventory (MEDI). Ferdowsi University of Mashhad Approved 2023-09-11 Ethics committee of Ferdowsi University of Mashhad Ferdowsi University of Mashhad, Azadi Square, Razavi Khorasan Province, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)