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IRCT20170417033485N1 IRCT 2021-07-20 Bagheiat-allah University of Medical Sciences The Effectiveness of Dialectical Behavior Therapy and repetitive Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex on Symptoms of Borderline Personality Disorder: A Single blind randomized controlled clinical trial The Effectiveness of Dialectical Behavior Therapy and repetitive Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex on Symptoms of Borderline Personality Disorder: A Single blind randomized controlled clinical trial 2021-05-26 anticipated 50 Complete https://irct.ir/trial/56577 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: For randomization, the restricted randomization method of the type of permuted block randomization (Random quadruple blocks) will be used and for this purpose, the online system sealedenvelop.com will be used, which randomly divides the four main intervention groups (D, C, B, E, …). Then the first patient enters group D, the second patient in group C, etc. until the groups are completed, Blinding description: Once the relevant groups have been identified, the study is designed in such a way that, except for the lead researcher, none of the subjects and all those who come into contact with them unaware of the assignment of the study groups. For this purpose, first of all, all patients have the idea that each of them receives the intervention and are also unaware of the type of intervention. Second, other colleagues who are in contact with patients along the study path do not know the study group and its type. N/A Borderline Personality Disorder. Intervention 1: Dialectical Behavior Therapy: Dialectical behavioral therapy is a special type of cognitive behavioral therapy which developed in the late of 1980s by Marsha Linhan to help better treatment of borderline personality disorder; But it is currently used to treat a variety of psychological disorders. In this study, two groups will receive dialectical behavior therapy (DBT). The first is the group that receives DBT alone, and the group that receives it after receiving repetitive Transcranial Magnetic Stimulation (rTMS) sessions. DBT will be performed as group psychotherapy for 8 to 12 sessions (Linhan, 1993). After the intervention, questionnaires and Flanker test will be taken immediately after and one month later. Intervention 2: repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. In this study, a group will receive real rTMS and a placebo group received it artificially. In the rTMS group, rTMS will be performed with the device of Magstim Company under the supervision of a psychiatrist and a physiologist of the psychiatry center located in Imam Hossein (AS) Hospital. As mentioned, according to previous studies, the target area for this purpose will be right dorsolateral prefrontal cortex (right DLPFC) with a frequency of 10 Hz for 8 to 10 sessions of 20 minutes per day for two weeks. The placebo group will lie on the device but will not recieve any stimuluatin. After the intervention, questionnaires and Flanker test will be taken immediately after and one month later. Intervention 3: Dialectical Behavior Therapy + repetitive Transcranial Magnetic Stimulation: This group receives two interventions and after performing and completing rTMS sessions (10 Hz for 8 to 10 sessions for 20 minutes per day for two weeks on DLPFC right hemisphere), 8 to 12 DBT sessions (Linhan, 1993) will be done. After the intervention, questionnaires and Flanker test will be taken immediately after and one month later. Intervention 4: Negative control group (waiting list) with sham brain stimulation: This group includes borderline patients who do not receive any intervention and whose brain stimulation is artificial. Sham rTMS stimulation was delivered using the same stimulation parameters and at the same site; however, a sham coil was used. Intervention 5: Positive control group includes healthy people: Healthy people who do not receive any intervention. Yes - There is a plan to make this available What will be shared: All personal data of the study participants can be shared after encoding individuals. When: Data release time will be available after the relevant articles are published. To whom: All researchers Conditions: If the articles of this project are cited to. Where to obtain: Alireza Mohammadi How to obtain: By sending an email to the project manager Comments:
public Alirza Mohammadi
Vanak Square, Mulla Sadra Street, Sheikh Baha'i Intersection
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8862 3188 ar.mohammadi@bmsu.ac.ir Bagheiat-allah University of Medical Sciences scientific Alireza Mohammadi
C5 uinit, No 5, Kharami Street, Mulla Sadra Street, Vanak Square
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8862 3188 ar.mohammadi@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Diagnosis of an experienced psychiatrist and possession of diagnostic properties of borderline personality disorder based on DSM-5 and SCID-5-PD Minimum diploma education Age range between 18 and 45 years Failure to receive psychological treatment in the past with the aim of treating borderline personality disorder At least five times self injury (self-harm) in the past 18 years 45 years Male Having prominent psychotic symptoms and uncontrollable suicidal thoughts Having delusional disorders Patients undergoing psychotherapy at the time of selection F60.3 Borderline personality disorder Treatment - Other Treatment - Devices Treatment - Other Placebo Other Dialectical Behavior Therapy: Dialectical behavioral therapy is a special type of cognitive behavioral therapy which developed in the late of 1980s by Marsha Linhan to help better treatment of borderline personality disorder; But it is currently used to treat a variety of psychological disorders. In this study, two groups will receive dialectical behavior therapy (DBT). The first is the group that receives DBT alone, and the group that receives it after receiving repetitive Transcranial Magnetic Stimulation (rTMS) sessions. DBT will be performed as group psychotherapy for 8 to 12 sessions (Linhan, 1993). After the intervention, questionnaires and Flanker test will be taken immediately after and one month later. repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. In this study, a group will receive real rTMS and a placebo group received it artificially. In the rTMS group, rTMS will be performed with the device of Magstim Company under the supervision of a psychiatrist and a physiologist of the psychiatry center located in Imam Hossein (AS) Hospital. As mentioned, according to previous studies, the target area for this purpose will be right dorsolateral prefrontal cortex (right DLPFC) with a frequency of 10 Hz for 8 to 10 sessions of 20 minutes per day for two weeks. The placebo group will lie on the device but will not recieve any stimuluatin. After the intervention, questionnaires and Flanker test will be taken immediately after and one month later. Dialectical Behavior Therapy + repetitive Transcranial Magnetic Stimulation: This group receives two interventions and after performing and completing rTMS sessions (10 Hz for 8 to 10 sessions for 20 minutes per day for two weeks on DLPFC right hemisphere), 8 to 12 DBT sessions (Linhan, 1993) will be done. After the intervention, questionnaires and Flanker test will be taken immediately after and one month later. Negative control group (waiting list) with sham brain stimulation: This group includes borderline patients who do not receive any intervention and whose brain stimulation is artificial. Sham rTMS stimulation was delivered using the same stimulation parameters and at the same site; however, a sham coil was used. Positive control group includes healthy people: Healthy people who do not receive any intervention. The score of Borderline Personality Disorder Severity Index (BPDSI). Timepoint: Before the intervention (Pre-test), after the intervention (Post-test) and one month after the intervention (Following). Method of measurement: Borderline Personality Disorder Severity Index (BPDSI). Distress Tolerance Scale (DTS). Timepoint: Before the intervention (Pre-test), after the intervention (Post-test) and one month after the intervention (Following). Method of measurement: Distress Tolerance Scale (DTS) Questionnaire. Barratt Impulsiveness Scale. Timepoint: Before the intervention (Pre-test), after the intervention (Post-test) and one month after the intervention (Following). Method of measurement: Barratt Impulsiveness Scale Questionnaire. Difficulties in Emotion Regulation Scale. Timepoint: Before the intervention (Pre-test), after the intervention (Post-test) and one month after the intervention (Following). Method of measurement: Difficulties in Emotion Regulation Scale Questionnaire. does not have Approved 2021-05-25 Biomedical Research Ethics Committee of Baqiyatallah Hospital Vanak Square, Mulla Sadra Street, Sheikh Baha'i Intersection Tehran Tehran Iran (Islamic Republic of)