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IRCT20230730058968N1 IRCT 2023-09-05 Islamic Azad University Comparison of the effectiveness of transcranial direct electrical stimulation of the brain (tDCS) with cognitive rehabilitation in the treatment of drug addicts undergoing maintenance treatment. Comparison of the effectiveness of transcranial direct electrical stimulation of the brain (tDCS) with cognitive rehabilitation on selective attention, cognitive flexibility, response inhibition and craving in drug addicts undergoing maintenance treatment. 2023-08-06 anticipated 45 Complete https://irct.ir/trial/71660 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: Due to the fact that in this study, the participants receive one of cognitive rehabilitation interventions or direct transcranial electrical stimulation of the brain, it was not possible to blind the participants, Randomization description: To allocate people in the study groups, the dice throwing method was used so that the numbers 1 and 2 are for the placement of people in the tDCS treatment group, the numbers 3 and 4 are for the placement of people in the cognitive rehabilitation group and the numbers 5 and 6 are for the placement of people in the the control group was defined, Blinding description: In this study, the members of the medical centers from which the patients were selected, as well as the two people who evaluated and completed the tools used in the research, were kept blind to the allocation of the study groups. N/A Addicts undergoing maintenance treatment. Intervention 1: Intervention group: experimental group A will receive ten sessions of transcranial electric current stimulation. Intervention with OASIS PRO WITH tDCS device from MIND ALIVE company was used. Subjects in this group participated in treatment sessions every other day for ten sessions. Anode electrode was placed in the posterolateral region of the left prefrontal cortex and cathode electrode was placed in the posterolateral region of the right prefrontal cortex, and in each session for 20 minutes, a current of 2 milliamps of direct electric current was passed through the skull of the subjects. Intervention 2: Intervention group: The experimental group received ten sessions of cognitive rehabilitation, which used Nejati's cognitive rehabilitation computer program (2010), which includes strengthening working memory, strengthening selective attention, strengthening sustained attention, and strengthening transitional attention. It was performed in 10 sessions of 30 minutes and 3 sessions per week. Intervention 3: Control group: The control group will continue their usual treatment program and receive no other intervention. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals When: Access starts 6 months after results are published To whom: The data will be available to researchers working in scientific and academic institutions Conditions: Data will be accessible for analyzes related to review studies and meta-analysis Where to obtain: To receive documents, you can contact researcher6411@gmail.com How to obtain: The authorized data file will be available to the applicants as soon as they see the message in the e-mail, within a week Comments:
public Somayeh Bagheri
Islamic Azad University, Semnan Branch, Faculty of Humanities, Department of Psychology
Semnan Iran (Islamic Republic of) 3513137111 +98 23 3365 4231 researcher6411@gmail.com Islamic Azad University scientific Somayeh Bagheri
Islamic Azad University, Semnan Branch, Faculty of Humanities, Department of Psychology
Semnan Iran (Islamic Republic of) 3513137111 +98 23 3365 4231 researcher6411@gmail.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) At least two months have passed since the start of treatment End of induction and stabilization period Negative drug test Having at least a high school diploma Written consent to enter the research 18 years 60 years Male Receiving other psychological interventions Having or having a history of epilepsy or other brain diseases and psychosis Mental retardation Taking drugs or anti-anxiety drugs F11.2 Opioid dependence Treatment - Devices Treatment - Other N/A Intervention group: experimental group A will receive ten sessions of transcranial electric current stimulation. Intervention with OASIS PRO WITH tDCS device from MIND ALIVE company was used. Subjects in this group participated in treatment sessions every other day for ten sessions. Anode electrode was placed in the posterolateral region of the left prefrontal cortex and cathode electrode was placed in the posterolateral region of the right prefrontal cortex, and in each session for 20 minutes, a current of 2 milliamps of direct electric current was passed through the skull of the subjects. Intervention group: The experimental group received ten sessions of cognitive rehabilitation, which used Nejati's cognitive rehabilitation computer program (2010), which includes strengthening working memory, strengthening selective attention, strengthening sustained attention, and strengthening transitional attention. It was performed in 10 sessions of 30 minutes and 3 sessions per week Control group: The control group will continue their usual treatment program and receive no other intervention Selective attention. Timepoint: Before the start of the intervention and at the end of the intervention. Method of measurement: Stroop test. Cognitive flexibility. Timepoint: Before the start of the intervention and at the end of the intervention. Method of measurement: Dennis and Vander Waal (2010) cognitive flexibility questionnaire (CFI). Response inhibition. Timepoint: Before the start of the intervention and at the end of the intervention. Method of measurement: go / no go test. Craving. Timepoint: Before the start of the intervention and at the end of the intervention. Method of measurement: Craving intensity test. Islamic Azad University Approved 2023-06-21 Islamic Azad University, Semnan branch Islamic Azad University, Semnan Branch, Faculty of Humanities, Department of Psychology Semnan Semnan Iran (Islamic Republic of)