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IRCT20120502009620N2 IRCT 2022-07-13 Kermanshah University of Medical Sciences Comparing the Effect of tDCS With CBT Interventions on the stress and anxiety and depression and relapse in abstinent methamphetamine-dependent subjects Comparing the Effect of Transcranial Direct Current Stimulation (tDCS) With Cognitive-Behavioral therapy (CBT) Interventions on the stress and anxiety and depression and relapse in abstinent methamphetamine-dependent subjects in Farabi Hospital. 2022-07-23 anticipated 80 Complete https://irct.ir/trial/63851 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Random numbers are generated using R software and General Integer option, so that the largest and smallest desired number (1 and 10) with the specified sample size (80 people) is entered in the software and a random combination of 80 is created from numbers 1 to 10. The generated sample is then used to assign individuals to the samples. In this way, every ten random numbers generated in a block is a random combination of numbers from 1 to 10. N/A Methamphetamine addiction. Intervention 1: Intervention group: 1- tDCS: Oasis Pro tDCS from Mind Alive Canada will be used to stimulate direct current stimulation. Anode or excitation electrode with dimensions of 25cm2 (5 * 5 cm) on the left prefrontal cortex (F3) and cathodal or inhibitory electrode with dimensions of 25cm2 (5 * 5 cm) on the right prefrontal cortex (F4), It will be set at 1 mA for 20 minutes, then rested for 15 minutes and then the second phase of electrical stimulation will be applied exactly according to the previous protocol and for a duration of 10 sessions of treatment . In order to eliminate the carry-over effect and also the possibility of patients' exposure to other environmental stimuli, sessions with a time interval of 48 hours have been considered. Intervention 2: Intervention group: 2- CBT: Cognitive-behavioral therapy (CBT) sessions based on the matrix model include a 2-month treatment period containing 24 treatment sessions of 3 sessions per week with 45-minute period, individually or in groups of 4 to 12 for individuals in cognitive - behavior therapy experimental groups will be performed, which is as follows. These therapy sessions will be performed using the psychotherapy of dependence on stimulants (glass) with the matrix pattern. Title of treatment sessions includes, Session 1: Individual motivational feedback and evaluation of the benefits of quitting drugs for the individual. Session 2: Introducing High-Risk Situations and Triggers. Session 3: Introducing the recovery path and roadmap. Session 4 and 5: Introduction and diagnosis of external and internal starters. Sessions 6, 7 and 8: Identify major problems on the path to recovery, including: family distrust, reduced energy and power, misuse of drugs and other substances as alternatives. Sessions 9, 10 and 11: Dealing with the desire to use drugs (dealing with temptation) and the wrong ways to deal with temptation. Session 12: Dealing with negative thinking and identifying thoughts, feelings and precursor behaviors of consumption. Session 13: Identify the feelings and physical symptoms of depression and boredom. Session 14: Training on relapse prevention activities. Session 15: Introduction to relapse predisposing activities. Session 16: Examining employment and its role in the process of recovery. Session 17: Familiarity with feelings of shame and guilt and how to manage them. Session 18: The role of enjoyable and exciting activities in the daily routine. Session 19: How do we shape our motivation for recovery? Session 20: Introduction to truthfulness skills during recovery. Session 21: Learning problem-solving skills without the use of any drugs (complete purity). Session 22: Familiarity with the process of addictive sexual relations and its complications. Sessions 23 and 24: Identify behaviors related to recurrence and prevent them. Intervention 3: Intervention group: Combined group CBT and tDCS: Electrical stimulation intervention and cognitive-behavioral therapy will be applied simultaneously to individuals in this group as mentioned in interventions 1 and 2. Intervention 4: Control group: The control group will consist of 20 participants who will not receive any electrical intervention or cognitive behavioral therapy and all questionnaire and laboratory tests will be taken from them. Since this group is also an sham electrical intervention group, the tDCS device will be placed on their head with exactly the same conditions as the electrical intervention group, but no electric current will be applied to their skulls and the device will only be turned on and off once for them. Yes - There is a plan to make this available What will be shared: All personal data and consent and treatment protocol and statistical analysis map and clinical study report can be shared after unrecognizable individuals. When: Access period starts 6 months after the results are published To whom: For all researchers interested in the subject of this study Conditions: With the aim of continuing research and related research work Where to obtain: Contact the Substance Abuse Research Center located in Farabi Hospital of Kermanshah University of Medical Sciences. How to obtain: First, contact the Substance Abuse Research Center located in Farabi Hospital of Kermanshah University of Medical Sciences, and then the person in charge of responding to this research will provide them with information. Comments:
public Tahereh Sadat Javadifar
Substance Abuse Prevention Research Center, Kermanshah University of Medical Sciences
Kermanshah Iran (Islamic Republic of) 6718768815 +98 83 3836 2532 tjavadifar@yahoo.com Kermanshah University of Medical Sciences scientific Tahereh Sadat Javadifar
Substance Abuse Prevention Research Center, Kermanshah University of Medical Sciences
Kermanshah Iran (Islamic Republic of) 6718768815 +98 83 3836 2532 tjavadifar@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Male Right-hand Has a minimum education level of diploma Age over 18 years Has a minimum 6 months Methamphetamine use before treatment During Methamphetamine abstinence 18 years no limit Male Drug interventions Existence of metal in head and neck History of seizures The presence of a pacemaker in the heart Psychiatric disorders Addiction Alcohol consumption Consumption of sedatives F15.2 Other stimulant dependence Rehabilitation Rehabilitation Rehabilitation Placebo Intervention group: 1- tDCS: Oasis Pro tDCS from Mind Alive Canada will be used to stimulate direct current stimulation. Anode or excitation electrode with dimensions of 25cm2 (5 * 5 cm) on the left prefrontal cortex (F3) and cathodal or inhibitory electrode with dimensions of 25cm2 (5 * 5 cm) on the right prefrontal cortex (F4), It will be set at 1 mA for 20 minutes, then rested for 15 minutes and then the second phase of electrical stimulation will be applied exactly according to the previous protocol and for a duration of 10 sessions of treatment . In order to eliminate the carry-over effect and also the possibility of patients' exposure to other environmental stimuli, sessions with a time interval of 48 hours have been considered. Intervention group: 2- CBT: Cognitive-behavioral therapy (CBT) sessions based on the matrix model include a 2-month treatment period containing 24 treatment sessions of 3 sessions per week with 45-minute period, individually or in groups of 4 to 12 for individuals in cognitive - behavior therapy experimental groups will be performed, which is as follows. These therapy sessions will be performed using the psychotherapy of dependence on stimulants (glass) with the matrix pattern. Title of treatment sessions includes, Session 1: Individual motivational feedback and evaluation of the benefits of quitting drugs for the individual. Session 2: Introducing High-Risk Situations and Triggers. Session 3: Introducing the recovery path and roadmap. Session 4 and 5: Introduction and diagnosis of external and internal starters. Sessions 6, 7 and 8: Identify major problems on the path to recovery, including: family distrust, reduced energy and power, misuse of drugs and other substances as alternatives. Sessions 9, 10 and 11: Dealing with the desire to use drugs (dealing with temptation) and the wrong ways to deal with temptation. Session 12: Dealing with negative thinking and identifying thoughts, feelings and precursor behaviors of consumption. Session 13: Identify the feelings and physical symptoms of depression and boredom. Session 14: Training on relapse prevention activities. Session 15: Introduction to relapse predisposing activities. Session 16: Examining employment and its role in the process of recovery. Session 17: Familiarity with feelings of shame and guilt and how to manage them. Session 18: The role of enjoyable and exciting activities in the daily routine. Session 19: How do we shape our motivation for recovery? Session 20: Introduction to truthfulness skills during recovery. Session 21: Learning problem-solving skills without the use of any drugs (complete purity). Session 22: Familiarity with the process of addictive sexual relations and its complications. Sessions 23 and 24: Identify behaviors related to recurrence and prevent them. Intervention group: Combined group CBT and tDCS: Electrical stimulation intervention and cognitive-behavioral therapy will be applied simultaneously to individuals in this group as mentioned in interventions 1 and 2. Control group: The control group will consist of 20 participants who will not receive any electrical intervention or cognitive behavioral therapy and all questionnaire and laboratory tests will be taken from them. Since this group is also an sham electrical intervention group, the tDCS device will be placed on their head with exactly the same conditions as the electrical intervention group, but no electric current will be applied to their skulls and the device will only be turned on and off once for them. Stress score in DASS test. Timepoint: Stress scores will be measured at the beginning of the study, ie one week before the intervention and after 10 sessions of direct current stimulation intervention and after 24 sessions of cognitive-behavioral therapy intervention. All tests will be repeated 4 months after the end of the study to follow the therapeutic effects. Method of measurement: DَASS-21 Stress, Anxiety and Depression Questionnaire. Anxiety score in DASS test. Timepoint: Anxiety scores will be measured at the beginning of the study, ie one week before the intervention and after 10 sessions of direct current stimulation intervention and after 24 sessions of cognitive-behavioral therapy intervention. All tests will be repeated 4 months after the end of the study to follow the therapeutic effects. Method of measurement: DَASS-21 Stress, Anxiety and Depression Questionnaire. Depression score in DASS test. Timepoint: Depression scores will be measured at the beginning of the study, ie one week before the intervention and after 10 sessions of direct current stimulation intervention and after 24 sessions of cognitive-behavioral therapy intervention. All tests will be repeated 4 months after the end of the study to follow the therapeutic effects. Method of measurement: DَASS-21 Stress, Anxiety and Depression Questionnaire. Relapse score in the Persian version of the AWAER questionnaire. Timepoint: Relapse score will be measured at the beginning of the study, ie one week before the intervention and after 10 sessions of direct current stimulation intervention and after 24 sessions of cognitive-behavioral therapy intervention. All tests will be repeated 4 months after the end of the study to follow the therapeutic effects. Method of measurement: Persian version of the AWAER questionnaire. Salivary cortisol level. Timepoint: Salivary cortisol level will be measured at the beginning of the study, ie one week before the intervention and after 10 sessions of direct current stimulation intervention and after 24 sessions of cognitive-behavioral therapy intervention. All tests will be repeated 4 months after the end of the study to follow the therapeutic effects. Method of measurement: Salivary cortisol test kit. Kermanshah University of Medical Sciences Approved 2022-05-21 Research Etichs committees of kermanshah university of medical science Shahid Beheshti Blvd. Building No. 2, Kermanshah University of Medical Sciences, Research and Technology Vice-Chancellor Kermanshah Kermanshah Iran (Islamic Republic of)