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IRCT20230318057753N1 IRCT 2023-05-20 Bojnourd University of Medical Sciences Synergistic comparison of the effectiveness of cognitive-behavioral therapy and cranial direct current stimulation therapy on the dorsal lateral prefrontal cortex on reducing cravings and clinical signs and improving neuropsychological functions in Stimulant substance abusers Synergistic comparison of the effectiveness of cognitive-behavioral therapy (CBT) and cranial direct current stimulation therapy (tDCS) on the dorsal lateral prefrontal cortex (DLPFC) on reducing cravings and clinical signs and improving neuropsychological functions in amphetamin addicts . 2023-05-05 anticipated 40 Complete https://irct.ir/trial/69737 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the nature of the research, a quantitative and experimental approach is used. Quantitative approach is a research orientation that studies the studied phenomenon based on numerical and statistical indicators (Creswell, 2012). It should be noted that based on the purpose of the research, the current research is an applied research. Because its findings can help solve the problems ahead.Due to the availability of a sufficient sample for group research, the current research design is semi-experimental with a pre-test-post-test design with a control group. Considering the topic of the present research, PASS software will be used first to estimate the sample size with an alpha error coefficient of 0.05 and a beta error coefficient of 0.8 (Jabari Nougabi, 2009). After that, the people who meet the criteria for entering the research are randomly assigned to 4 groups (three experimental groups and one control group). Then by manipulating the independent variable, i.e. providing cognitive-behavioral therapy and tDCS stimulation therapy to the test groups, its effect on the dependent variables (reduction of basic and induced cravings, reduction of clinical symptoms of anxiety and depression, and The improvement of neuropsychological functions, i.e., cognitive inhibition and behavioral inhibition in the treatment of patients with glass (amphetamine) abuse disorder will be measured and analyzed. Before the intervention, a pre-test will be done from all four groups (three experimental groups and one control group) by implementing research questionnaires. Then, test group 1 received cognitive-behavioral therapy (CBT) and test group 2 received tDCS (DLPFC area) with the right anode-left cathode protocol and the third group received both treatments to check synergy. will do And the control group will not receive any intervention. After the implementation of the intervention, a post-test of all four groups will be conducted by implementing research questionnaires, Blinding description: According to the designed diagram of the research plan, after placing the sample subjects into three test groups and one control group based on the specified treatment protocols, the pre-test will be done from all four groups. Then, the number of sessions and the days of the sessions will be coordinated with the patients, and after the end of the treatment sessions (sessions will be held weekly in two 45-minute sessions), a post-test will be done for all four groups. It should be mentioned that in order to control the intervening variables, people in 4 groups will first be replaced by a random method, which is the simplest method of controlling the intervening variables, and then based on the theoretical foundations of the research and the intervening variables, the people of the 4 groups will be matched until the variables Intervener to be controlled. Finally, a one-sided blind intervention study method will be used in which the participants are not aware of which group they have been placed in and what treatment method has been prescribed for them. This research is in phase two. Because in this phase, the emphasis is on effectiveness. This stage is done with the aim of obtaining preliminary information about whether tDCS and CBT treatments work in the experimental group or not. To control the side effects of the intervention, ethical considerations will be observed in the research and all people will participate in the research with informed consent and the subjects will be properly informed of all the information that can be effective in making decisions. This information will include: the title and objectives of the research, the duration of the research and the method that is going to be used. Also, every subject can withdraw from the study at any time and will be informed and supported about the potential risks and losses caused by early withdrawal from the study. The researcher will also answer all the questions and concerns of the sample people patiently and accurately. These items are reflected in the informed consent. The researcher is responsible for observing the principle of confidentiality and keeping the subjects' secrets and taking appropriate measures to prevent their publication, and any kind of damage or loss caused by participating in the research will be compensated by the researcher. At the end of the research, any person from the sample, who wants to know about the results of the research, will be provided with the results. 1-2 addiction. Intervention 1: Intervention group: treatment only (CBT) In order to investigate the effectiveness of cognitive behavioral therapy on the dependent variables of the research (reduction of basic and induced cravings, reduction of clinical symptoms of anxiety and depression, and improvement of neuropsychological functions i.e. cognitive inhibition and behavioral inhibition) in the treatment of patients with (amphetamine) abuse disorder ) The people receiving this intervention, who are 10 people, will only undergo cognitive behavioral therapy according to the designed protocol (10 sessions of 45 minutes). Intervention 2: Intervention group: Treatment only (tDCS) Intervention group: only treatment (tDCS) in order to investigate the effectiveness of stimulation treatment with direct current from the skull on dependent variables (reduction of basic and induced cravings, reduction of clinical symptoms of anxiety and depression, and improvement of neuropsychological functions, i.e. cognitive inhibition and behavioral inhibition) In the treatment of patients suffering from (amphetamine) abuse disorder, the people receiving this intervention, who are 10 people, will only be treated with direct current stimulation from the skull with the right anode-left cathode protocol (10 sessions) of 20 minutes. Intervention 3: Intervention group: therapy (CBT) and therapy (tDCS) Intervention group: treatment (CBT) and treatment (tDCS) in order to investigate the effectiveness of co-administration (combination) of cognitive behavioral therapy with stimulation therapy with direct current from the skull on the dependent variables (reduction of basic and induced cravings, reduction of clinical symptoms of anxiety and Depression, and improvement of neuropsychological functions, i.e., cognitive inhibition and behavioral inhibition in the treatment of patients with (amphetamine) abuse disorder. There are 10 participants after receiving cognitive behavioral therapy according to the designed protocol (10 sessions of 45 minutes). will be treated with direct current stimulation from the skull with right anode-left cathode protocol (10 sessions of 20 minutes). Intervention 4: Control group: Failure to receive intervention In order to investigate and verify the combined effect of independent variables, i.e., cognitive behavioral therapy and stimulation therapy with direct current from the skull on dependent variables (reduction of basic and induced cravings, reduction of clinical symptoms of anxiety and depression, and improvement of functions Neuropsychology means cognitive inhibition and behavioral inhibition in the treatment of patients with glass (amphetamine) abuse disorder. The people receiving this intervention, who are 10 people, will not receive any other real intervention other than cognitive behavioral therapy. are placed in cognitive behavioral therapy, and in the therapeutic phase of stimulation with direct current from the skull in the dorsolateral prefrontal region, the stimulation in the skull region will be performed in a fake form, that is, the electrodes will be installed on their head, but the device is turned off and the current in the electrode There are no problems and practically no stimulation is done. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 1 year after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: Psychologists, psychiatrists, psychology and psychiatry students and patients interested in research Where to obtain: mahdi.helmzadeh@gmail.com How to obtain: After sending the request by email, within a maximum period of 1 month Comments:
public Mahdi Helmzadeh
Unit 2, No. 56, Daneshjo Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9188957646 +98 51 3867 6883 Mahdi.helmzadeh@gmail.com Bojnourd University of Medical Sciences scientific Dr. Morteza Modares Gharavi
Ibn Sina Psychiatric Hospital, Bo Ali Boulevard, Mashhad
Mashhad Iran (Islamic Republic of) 919583134 0098 51 3712701 Modaresm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Primary diagnosis of amphetamine abuse based on clinical interview based on DSM-5 Age range 20-50 years He had at least middle school education Lack of diagnosis of any psychiatric disorder (except substance abuse) Not receiving any psychiatric medication for at least 6 months before entering the study Not receiving any other psychological intervention during the study Subjects' consent to participate in the research Not suffering from any specific physical disease Not suffering from neurological diseases (epilepsy, multiple sclerosis). 20 years 50 years Male Having schizophrenia spectrum disorders and other psychotic disorders. Obsessive-compulsive disorder and related disorders. post-traumatic stress disorder and related disorders; Bipolar mood disorder and related disorders. Anxiety disorder caused by substances/drugs or caused by other medical conditions. Having a history of suicidal actions and thoughts. Having an injury in the head and neck area. history of consumption shorter than 6 months. History of implanting prosthesis in the head and neck area. F15.1 Mental and behavioural disorders due to use of other stimulants, including caffeine Behavior Treatment - Devices Treatment - Devices Placebo Intervention group: treatment only (CBT) In order to investigate the effectiveness of cognitive behavioral therapy on the dependent variables of the research (reduction of basic and induced cravings, reduction of clinical symptoms of anxiety and depression, and improvement of neuropsychological functions i.e. cognitive inhibition and behavioral inhibition) in the treatment of patients with (amphetamine) abuse disorder ) The people receiving this intervention, who are 10 people, will only undergo cognitive behavioral therapy according to the designed protocol (10 sessions of 45 minutes). Intervention group: Treatment only (tDCS) Intervention group: only treatment (tDCS) in order to investigate the effectiveness of stimulation treatment with direct current from the skull on dependent variables (reduction of basic and induced cravings, reduction of clinical symptoms of anxiety and depression, and improvement of neuropsychological functions, i.e. cognitive inhibition and behavioral inhibition) In the treatment of patients suffering from (amphetamine) abuse disorder, the people receiving this intervention, who are 10 people, will only be treated with direct current stimulation from the skull with the right anode-left cathode protocol (10 sessions) of 20 minutes. Intervention group: therapy (CBT) and therapy (tDCS) Intervention group: treatment (CBT) and treatment (tDCS) in order to investigate the effectiveness of co-administration (combination) of cognitive behavioral therapy with stimulation therapy with direct current from the skull on the dependent variables (reduction of basic and induced cravings, reduction of clinical symptoms of anxiety and Depression, and improvement of neuropsychological functions, i.e., cognitive inhibition and behavioral inhibition in the treatment of patients with (amphetamine) abuse disorder. There are 10 participants after receiving cognitive behavioral therapy according to the designed protocol (10 sessions of 45 minutes). will be treated with direct current stimulation from the skull with right anode-left cathode protocol (10 sessions of 20 minutes). Control group: Failure to receive intervention In order to investigate and verify the combined effect of independent variables, i.e., cognitive behavioral therapy and stimulation therapy with direct current from the skull on dependent variables (reduction of basic and induced cravings, reduction of clinical symptoms of anxiety and depression, and improvement of functions Neuropsychology means cognitive inhibition and behavioral inhibition in the treatment of patients with glass (amphetamine) abuse disorder. The people receiving this intervention, who are 10 people, will not receive any other real intervention other than cognitive behavioral therapy. are placed in cognitive behavioral therapy, and in the therapeutic phase of stimulation with direct current from the skull in the dorsolateral prefrontal region, the stimulation in the skull region will be performed in a fake form, that is, the electrodes will be installed on their head, but the device is turned off and the current in the electrode There are no problems and practically no stimulation is done. Craving for basic and induced amphetamines. Timepoint: Before the intervention, a pre-test will be done from all four groups (three experimental groups and one control group) by implementing research questionnaires. Then, test group 1 received cognitive-behavioral therapy (CBT) and test group 2 received tDCS (DLPFC area) with the right anode-left cathode protocol and the third group received both treatments to check synergy. will do And the control group will not receive any intervention.After the implementation of the intervention, a post-test of all four groups will be conducted by implementing research questionnaires. Method of measurement: Questionnaire Amphetamine baseline craving questionnaire Video test to measure induced craving. Clinical symptoms (anxiety and depression). Timepoint: Before the intervention, a pre-test will be done from all four groups (three experimental groups and one control group) by implementing research questionnaires. Then, test group 1 received cognitive-behavioral therapy (CBT) and test group 2 received tDCS (DLPFC area) with the right anode-left cathode protocol and the third group received both treatments to check synergy. will do And the control group will not receive any intervention.After the implementation of the intervention, a post-test of all four groups will be conducted by implementing research questionnaires. Method of measurement: questionnaire Beck depression questionnaire Beck's anxiety. Functions of neuropsychology (cognitive and behavioral inhibition). Timepoint: Before the intervention, a pre-test will be done from all four groups (three experimental groups and one control group) by implementing research questionnaires. Then, test group 1 received cognitive-behavioral therapy (CBT) and test group 2 received tDCS (DLPFC area) with the right anode-left cathode protocol and the third group received both treatments to check synergy. will do And the control group will not receive any intervention.After the implementation of the intervention, a post-test of all four groups will be conducted by implementing research questionnaires. Method of measurement: Neuropsychological Test of Behavioral Inhibition GO-NO GO-NO-GO (1984) Stroop cognitive inhibition neuropsychology test (1935). Bojnourd University of Medical Sciences Approved 2022-11-21 Research Ethics Committee of Islamic Azad University - Bojnord Branch Unit 2, No. 56, Daneshjo Blvd, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)