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IRCT20220518054902N1 IRCT 2022-05-28 Islamic azad university, arak branch Comparison of the effectiveness of direct electrical brain movement and cognitive-behavioral therapy in executive function and consumption in individuals with substance abuse Comparison of the effectiveness of direct electrical brain movement and cognitive-behavioral therapy in executive function and consumption in individuals with substance abuse 2022-05-22 anticipated 45 Complete https://irct.ir/trial/63630 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A clinical trial consisting of two control groups and a control group, with parallel, randomized groups, on 45 patients. For random allocation, the block-making method (quadruple blocks) is used. A list of blocks is written and numbers are assigned to them, and finally the treatment allocation list is determined based on random numbers. To do this, a random block sequencing website is used. Random block sequencing is provided to a specific person outside the research team who is responsible for random allocation, Blinding description: Both experimental groups for blinding in 10 sessions, one group participates in cognitive-behavioral therapy sessions and the other group participates in sessions of electrical stimulation of the brain, and the control group does not receive any intervention. Attempts are made to schedule the meetings in such a way that the members of the control and intervention group do not collide with each other and are not informed about the content of each other's meetings. Also, the participant is not aware of the result. N/A People with a history of substance abuse. Intervention 1: Direct electrical stimulation period of the brain: twice a week on Sundays and Thursdays for 5 consecutive weeks as follows. How to hold meetings. The treatment plan will be the same in all 10 sessions of intervention in terms of type, severity and duration of stimulation. During the treatment sessions, the subject will sit on a comfortable chair, then according to the standard system of 10 to 20 electroencephalography reported by Jasper, points will be identified on the subject's head and the anode electrode on the lateral dorsal lateral cortex and the cathode electrode on the lateral dorsal cortex. His right forehead will be placed and applied with a pair of sponge electrodes measuring 3.5 cm of direct current generated by a current of 2 mA with 30 seconds of up and down for 20 minutes. During the stimulation, the subject sits on a chair and does not perform a specific task. Intervention 2: Group cognitive-behavioral therapy will be based on Beck theory's cognitive-behavioral therapy. This intervention will be taught in 10 sessions as follows: Session 1: initial acquaintance and establishing a therapeutic relationship, raising the main complaints of women, brief introduction of the type of treatment, collaborating with the research sample in determining the goals of the treatment protocol, determining the relationship between cognition, Emotion and behavior, choosing goals and identifying goals and agreeing on homework, recording life events. Session 2: Formulation of general problems of addicts in the form of cognitive-behavioral model, integration of cognitive triangle in treatment strategies, use of standard behavioral activation techniques , Redesigning negative spontaneous thoughts and presenting dysfunctional thoughts record sheet. Session 3: Continuing to work with spontaneous thoughts, examining patients' dysfunctional thoughts record sheets, challenging spontaneous thoughts by Socrates method. Session 4: Recognizing underlying beliefs and how to activate them in situations Specifically, the use of downward arrow technique, review of some of the patients' target issues. Session 5: Developing awareness of underlying beliefs, strengthening positive self-talk, using behavioral techniques to replace positive thoughts instead of negative thoughts. Session 6: Use of cognitive-behavioral techniques about daring, Problem Solving and Teaching Social Skills to Addicts Session 7: Identify more unconditional and nuclear beliefs, weaken unconditional beliefs by questioning them in a Socratic manner, and rate negative beliefs on a scale of 0 to 100. Session 8: Continued Generating and developing alternative positive beliefs through the development of social and communication skills, developing problem-solving skills and courageous behaviors, grading alternative thoughts, preparing to apply the methods learned in future life situations. Session 9: Skills training Communication, group discussion, supplementary activities, teaching effective verbal response style and active listening skills. Session 10: Teaching self-control and alertness skills, group discussion, providing complementary activities and post-test. Intervention 3: Control group:. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of moral issues
public Mohammad Entezamimehr
No. 47, Eighth floor, Industry building, Zahiralaslam St., Jomhory St, Tehran.
Tehran Iran (Islamic Republic of) 1146835785 +98 21 3392 7727 Email4m.mehr@gmail.com Islamic azad university, arak branch scientific Mohammad Entezamimehr
No. 47, Eighth floor, Industry building, Zahiralaslam St., Jomhory St, Tehran.
Tehran Iran (Islamic Republic of) 1146835785 +98 21 3392 7727 Email4m.mehr@gmail.com Islamic azad university, arak branch Iran (Islamic Republic of) Completion of informed consent form, age range 20 to 40 years, opioid dependence, constant amount of medication (methadone, bo pro norphine, etc.) until the end of the project, having an up-cycle education, being right-handed 20 years 40 years Male Treatment - Other Treatment - Other N/A Direct electrical stimulation period of the brain: twice a week on Sundays and Thursdays for 5 consecutive weeks as follows. How to hold meetings. The treatment plan will be the same in all 10 sessions of intervention in terms of type, severity and duration of stimulation. During the treatment sessions, the subject will sit on a comfortable chair, then according to the standard system of 10 to 20 electroencephalography reported by Jasper, points will be identified on the subject's head and the anode electrode on the lateral dorsal lateral cortex and the cathode electrode on the lateral dorsal cortex. His right forehead will be placed and applied with a pair of sponge electrodes measuring 3.5 cm of direct current generated by a current of 2 mA with 30 seconds of up and down for 20 minutes. During the stimulation, the subject sits on a chair and does not perform a specific task. Group cognitive-behavioral therapy will be based on Beck theory's cognitive-behavioral therapy. This intervention will be taught in 10 sessions as follows: Session 1: initial acquaintance and establishing a therapeutic relationship, raising the main complaints of women, brief introduction of the type of treatment, collaborating with the research sample in determining the goals of the treatment protocol, determining the relationship between cognition, Emotion and behavior, choosing goals and identifying goals and agreeing on homework, recording life events. Session 2: Formulation of general problems of addicts in the form of cognitive-behavioral model, integration of cognitive triangle in treatment strategies, use of standard behavioral activation techniques , Redesigning negative spontaneous thoughts and presenting dysfunctional thoughts record sheet. Session 3: Continuing to work with spontaneous thoughts, examining patients' dysfunctional thoughts record sheets, challenging spontaneous thoughts by Socrates method. Session 4: Recognizing underlying beliefs and how to activate them in situations Specifically, the use of downward arrow technique, review of some of the patients' target issues. Session 5: Developing awareness of underlying beliefs, strengthening positive self-talk, using behavioral techniques to replace positive thoughts instead of negative thoughts. Session 6: Use of cognitive-behavioral techniques about daring, Problem Solving and Teaching Social Skills to Addicts Session 7: Identify more unconditional and nuclear beliefs, weaken unconditional beliefs by questioning them in a Socratic manner, and rate negative beliefs on a scale of 0 to 100. Session 8: Continued Generating and developing alternative positive beliefs through the development of social and communication skills, developing problem-solving skills and courageous behaviors, grading alternative thoughts, preparing to apply the methods learned in future life situations. Session 9: Skills training Communication, group discussion, supplementary activities, teaching effective verbal response style and active listening skills. Session 10: Teaching self-control and alertness skills, group discussion, providing complementary activities and post-test. Control group: Direct electrical stimulation of the brain, Cognitive-behavioral therapy. Timepoint: 3 month. Method of measurement: Therapeutic intervention of electrical stimulation of the brain, cognitive-behavioral therapy protocol. Islamic azad university, Arak branch Approved 2022-05-21 Research Ethics Committees of Islamic Azad University- Arak Branch No. 47, Eighth floor, Industry building, Zahiralaslam St., Jomhory St, Tehran. Tehran Tehran Iran (Islamic Republic of)