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IRCT20220511054824N1 IRCT 2023-09-11 Islamic Azad University Comparison of the effectiveness of tDCS, ACT and their combined effect on negative emotion, impulsiveness, perceived stress, cortisol، and estrogen levels in patients with migraine Comparison of the effectiveness of Transcranial Direct Current Stimulation (tDCS), Acceptance and Commitment Therapy (ACT) and their combined effect on negative emotion, impulsiveness, perceived stress, cortisol، and estrogen levels in patients with migraine headache 2022-04-21 anticipated 120 Complete https://irct.ir/trial/72396 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of patients to intervention and control groups was done by lottery. For this purpose, we write the names of all the people on small pieces of paper and put them in a container. We also prepare 4 different sheets with the names of 4 intervention and control groups. First, we open the sheet of the first intervention group and write the names of the first 30 subjects that come out of the container. For other groups, we continue until the end (30 people in the second intervention group, 30 people in the third intervention group, and 30 people in the control group), Blinding description: All participants were blinded to the way of distribution in groups, possible and expected results, and research assumptions, and no information about this was provided to them. N/A Migraine headaches. Intervention 1: The first intervention group, Transcranial Direct Current Stimulation (tDCS): The brain regions were localized using the EEG 10/20 system, and the anode and the cathode were located over the left and the right dorsolateral prefrontal cortex or DLPFC (F3 and F4), respectively. A current intensity of 2 mA for 20 min (30 s ramping up and 30 s ramping down at the start and end of stimulation) was used for 10 consecutive sessions (5 days per week). Direct current was transferred through a saline-soaked (0.9% NaCl) pair of surface sponge electrodes (size 5 cm x 5 cm=25 cm2 each) and powered by a battery-driven stimulator authorized for human use (NeuroStim 2, Medina Teb, Iran). Intervention 2: The second intervention group, Acceptance and Commitment Therapy (ACT): Vowles, Wetherell, and Sorrell ACT protocol was used, in which the subjects participated in 8 online sessions of ACT (on Skype), one-hour session per week. In this protocol, after introducing people and getting to know the generalities of the course, we worked on recognizing and accepting unpleasant personal events and painful experiences and being aware of hidden consequences, discovering and contacting them, changing language concepts, teaching relaxation, explaining the concept of role and context, observing self without judgment, explaining the concept of values, goals, and needs, creating motivation for change, training to practice and reviewing the tasks. Intervention 3: The third intervention group, the combination of Transcranial Direct Current Stimulation (tDCS) and Acceptance and Commitment Therapy (ACT): This intervention was performed as described in the intervention of the first and second groups. Intervention 4: Control group: This group did not receive any intervention during the research. However, to comply with the principle of fairness, all control group participants were allowed to take one of the interventions after the end of the research (tDCS or ACT). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Yasaman Damirchi
Amiral Mominin University Complex, Moazen Blvd., Rajaee Shahr
Karaj Iran (Islamic Republic of) 3149968111 +98 26 3425 9571 yasaman.damirchi@gmail.com Islamic Azad University scientific Yasaman Damirchi
Amiral Mominin University Complex, Moazen Blvd., Rajaee Shahr
Karaj Iran (Islamic Republic of) 3149968111 +98 26 3425 9571 yasaman.damirchi@gmail.com Islamic Azad University Iran (Islamic Republic of) Taking confirmed diagnosis of migraine, signing the written consent, Proficiency in Persian language, having access to the Internet and the Skype software (for groups taking the ACT course), being between the ages of 20 and 40, having no other effective physical or psychological conditions, and not undergoing drug and other treatments 20 years 40 years Female Receiving another treatment during the intervention, having a history of a serious medical or neurological disorder (for participants who received tDCS), such as multiple sclerosis, brain injury or tumors, Parkinson’s disease, seizures, dementia, brain stroke or any kind of heart disease, Huntington’s chorea, having cardiac pacemaker, having any metal objects in or near the head, and implanted medication pumps which would increase the risk of tDCS Treatment - Devices Treatment - Devices Treatment - Devices Other The first intervention group, Transcranial Direct Current Stimulation (tDCS): The brain regions were localized using the EEG 10/20 system, and the anode and the cathode were located over the left and the right dorsolateral prefrontal cortex or DLPFC (F3 and F4), respectively. A current intensity of 2 mA for 20 min (30 s ramping up and 30 s ramping down at the start and end of stimulation) was used for 10 consecutive sessions (5 days per week). Direct current was transferred through a saline-soaked (0.9% NaCl) pair of surface sponge electrodes (size 5 cm x 5 cm=25 cm2 each) and powered by a battery-driven stimulator authorized for human use (NeuroStim 2, Medina Teb, Iran). The second intervention group, Acceptance and Commitment Therapy (ACT): Vowles, Wetherell, and Sorrell ACT protocol was used, in which the subjects participated in 8 online sessions of ACT (on Skype), one-hour session per week. In this protocol, after introducing people and getting to know the generalities of the course, we worked on recognizing and accepting unpleasant personal events and painful experiences and being aware of hidden consequences, discovering and contacting them, changing language concepts, teaching relaxation, explaining the concept of role and context, observing self without judgment, explaining the concept of values, goals, and needs, creating motivation for change, training to practice and reviewing the tasks. The third intervention group, the combination of Transcranial Direct Current Stimulation (tDCS) and Acceptance and Commitment Therapy (ACT): This intervention was performed as described in the intervention of the first and second groups. Control group: This group did not receive any intervention during the research. However, to comply with the principle of fairness, all control group participants were allowed to take one of the interventions after the end of the research (tDCS or ACT). Negative emotion, impulsiveness, perceived stress, blood cortisol and estrogen levels. Timepoint: Before the start of the intervention, after the end of the intervention and three months after the end of the intervention. Method of measurement: Positive and negative affect scale (PANAS), Barratt impulsiveness scale (BIS), Perceived stress scale (PSS), Blood test to measure cortisol and estrogen levels. Islamic Azad University Approved 2022-08-31 Islamic Azad University-Karaj Branch Amiral Mominin University Complex, Moazen Blvd., Rajaee Shahr. Karaj Alborz Iran (Islamic Republic of)