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IRCT20230504058067N1 IRCT 2023-05-13 Islamic Azad University Effectiveness of Transcranial Direct Current Stimulation on obsessive-compulsive disorder Comparing the effectiveness of cognitive behavioral therapy; Transcranial Direct Current Stimulation and cognitive behavioral therapy with Transcranial Direct Current Stimulation on cognitive abilities of patients with obsessive-compulsive disorder: A randomized controlled trial 2023-06-22 anticipated 60 Complete https://irct.ir/trial/70039 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This controlled clinical trial study is going to be performed in Azad University both male and female students. Initial screening will be performed to determine the baselines. After screening, 60 participants are contacted via simple random sampling and shuffling. Upon arrival at the clinic, each invited person receives a sealed envelope with A, B or C code written on each envelope. This sequence is determined by someone other than the researchers using the site www.randomizer.org. Code A means the group will receive cognitive behavioral therapy; code B means the group will receive Transcranial Direct Current Stimulation and C means the group will receive cognitive behavioral therapy with Transcranial Direct Current Stimulation. Fisher and chi-square tests are also used to homogenize the underlying features, Blinding description: First of all, in order to blind the trial, a PhD student of psychology from the research group, encode participants information. In this project, blinding means more than just keeping the name of the participants are allocated in treatment or control group hidden. The patients will be blinded in the sense that they do not know they are receiving which kind of therapies. So, the participants are prevented from knowing certain information that may somehow influence them. N/A Obsessive compulsive disorder. Intervention 1: Intervention group 1: The protocol used for transcranial direct electrical stimulation in this research, according to the background, will be such that the intervention includes 2 milliamps of the anode position at F3 point and the cathode position at F4 point. The intervention consists of 8 sessions, each session of brain stimulation takes 20 minutes (either real or fake) and only one brain stimulation session will take place on each day. Meetings will be held two days a week. Intervention 2: Intervention group 2: In this group, cognitive behavioral therapy (12 sessions) is used simultaneously with transcranial direct electrical stimulation (8 sessions), so that after receiving 2 milliamperes, the anode position at the F3 point and the cathode position at the point F4 participates in a 45-minute cognitive-behavioral psychotherapy session for 20 minutes. Cognitive behavioral therapy includes psychoeducation about obsessive compulsive disorder, cognitive exercises such as cognitive restructuring, and behavioral exercises such as immersion. Intervention 3: Control group: In this group, cognitive behavioral therapy, which has the golden standard, is used as a control group. This protocol consists of 12 treatment sessions two days a week, which include psychoeducation about obsessive compulsive disorder, cognitive exercises, and behavioral exercises. Yes - There is a plan to make this available What will be shared: Data obtained from participants will be published unrecognizably in the primary information table in the article. The general data will be shared simultaneously with the publication of the main article. When: The data will be shared at the same time as the main article publication. To whom: Mainly, this data will be available to academic researchers and clinicians. Conditions: Thereafter publication of the article, a way of requesting data is introduced. Also, researchers can analyze the data only if the researchers agree. Where to obtain: Simultaneously with the publication of the article, a way of requesting data is introduced. How to obtain: Initially, the request is sent to the responsible author, after reviewing the group in order to prevent any kind of abuse, the information is sent in the form of a zip file. Comments:
public Hosein Ebrahimi_Moghadam
Islamic Azad University, Roudehen Branch, Motahari Blvd., Roudehen City
Roudehen Iran (Islamic Republic of) ۳۹۷۳۱۸۸۹۸۱ +98 21 7650 5891 Hem_psy@yahoo.com Islamic Azad University scientific Maryam Hosseini
Islamic Azad University, Roudehen Branch, Motahari Blvd., Roudehen City
Roudehen Iran (Islamic Republic of) ۳۹۷۳۱۸۸۹۸۱ +98 21 7650 5891 maryam.h.psychology@gmail.com Islamic Azad University Iran (Islamic Republic of) Having a diagnosis of obsessive compulsive disorder based on the Maudsley questionnaire Being in the age range of 18 to 35 years 18 years 35 years Both Absence in two consecutive sessions in each of the treatments Taking psychiatric drugs Use of other psychotherapy services F42 Obsessive-compulsive disorder Treatment - Other Treatment - Other Treatment - Other Intervention group 1: The protocol used for transcranial direct electrical stimulation in this research, according to the background, will be such that the intervention includes 2 milliamps of the anode position at F3 point and the cathode position at F4 point. The intervention consists of 8 sessions, each session of brain stimulation takes 20 minutes (either real or fake) and only one brain stimulation session will take place on each day. Meetings will be held two days a week. Intervention group 2: In this group, cognitive behavioral therapy (12 sessions) is used simultaneously with transcranial direct electrical stimulation (8 sessions), so that after receiving 2 milliamperes, the anode position at the F3 point and the cathode position at the point F4 participates in a 45-minute cognitive-behavioral psychotherapy session for 20 minutes. Cognitive behavioral therapy includes psychoeducation about obsessive compulsive disorder, cognitive exercises such as cognitive restructuring, and behavioral exercises such as immersion. Control group: In this group, cognitive behavioral therapy, which has the golden standard, is used as a control group. This protocol consists of 12 treatment sessions two days a week, which include psychoeducation about obsessive compulsive disorder, cognitive exercises, and behavioral exercises. Cognitive abilities include 8 subscales that are measured by Nejati cognitive abilities questionnaire. Timepoint: Session 1, Session 5, Final Session, two months after the last session. Method of measurement: Nejati cognitive abilities questionnaire. Islamic Azad University Approved 2023-05-08 Ethics Committee of Islamic Azad University, Roudehen Branch Academic complex of Islamic Azad University, Roudehen branch, Motahari Blvd., Roudehen Town Roudehen Tehran Iran (Islamic Republic of)