The Effectiveness of 3MA transcranial direct current stimulation (TDCS) on cognitive function, depression, anxiety and severity of obsessive-compulsive symptoms in individuals with OCD: A randomized clinical trial
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Protocol summary
A controlled, parallel-group, double-blind, randomized clinical trial on 32 patients. Simple randomization was used.
A controlled, parallel-group, double-blind, randomized clinical trial on 40 patients. Simple randomization was used.
A controlled, parallel-group, double-blind, randomized clinical trial on 3240 patients. Simple randomization was used.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، روی 32 بیمار. از تصادفی سازی ساده استفاده شده است.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، روی 40 بیمار. از تصادفی سازی ساده استفاده شده است.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، روی 3240 بیمار. از تصادفی سازی ساده استفاده شده است.
Having the full diagnostic criteria for obsessive-compulsive disorder as diagnosed by a psychiatrist and psychologist based on the diagnostic and statistical manual of mental disorders, age range 18 to 50 years, not receiving psychological treatment two months before the intervention, and simultaneously with the implementation of the intervention until the follow-up period, the same Being the drug group used along with adjusting the dose. Inclusion criteria: psychosis, risk of suicide, presence of electrical objects in the body, history of seizures, pregnancy
Having the full diagnostic criteria for obsessive-compulsive disorder as diagnosed by a psychiatrist and psychologist based on the diagnostic and statistical manual of mental disorders, age range 18 to 50 years, not receiving psychological treatment two months before the intervention, and simultaneously with the implementation of the intervention until the follow-up period, the same Being the drug group used along with adjusting the dose. Inclusion criteria: psychosis, risk of suicide, presence of electrical objects in the body, history of seizures, pregnancy, Comorbid bipolar disorder
Having the full diagnostic criteria for obsessive-compulsive disorder as diagnosed by a psychiatrist and psychologist based on the diagnostic and statistical manual of mental disorders, age range 18 to 50 years, not receiving psychological treatment two months before the intervention, and simultaneously with the implementation of the intervention until the follow-up period, the same Being the drug group used along with adjusting the dose. Inclusion criteria: psychosis, risk of suicide, presence of electrical objects in the body, history of seizures, pregnancy, Comorbid bipolar disorder
دارا بودن معیارهای کامل تشخیصی اختلال وسواسی-جبری به تشخیص روانپزشک و روانشناس بر اساس راهنمای تشخیصی و آماری اختلالات روانی، دامنه سنی 18 تا 50 سال، عدم دریافت درمان روانشناختی دو ماه قبل از مداخله و همزمان با اجرای مداخله تا مدت زمان پیگیری، یکسان بودن گروه دارویی مورد استفاده همراه با تنظیم دز. معیارهای عدم ورود: سایکوز، خطر خودکشی، وجود شی الکتریکی در بدن، سابقه ی تشنج، بارداری
دارا بودن معیارهای کامل تشخیصی اختلال وسواسی-جبری به تشخیص روانپزشک و روانشناس بر اساس راهنمای تشخیصی و آماری اختلالات روانی، دامنه سنی 18 تا 50 سال، عدم دریافت درمان روانشناختی دو ماه قبل از مداخله و همزمان با اجرای مداخله تا مدت زمان پیگیری، یکسان بودن گروه دارویی مورد استفاده همراه با تنظیم دز. معیارهای عدم ورود: سایکوز، خطر خودکشی، وجود شی الکتریکی در بدن، سابقه ی تشنج، بارداری، اختلال دوقطبی همبود
دارا بودن معیارهای کامل تشخیصی اختلال وسواسی-جبری به تشخیص روانپزشک و روانشناس بر اساس راهنمای تشخیصی و آماری اختلالات روانی، دامنه سنی 18 تا 50 سال، عدم دریافت درمان روانشناختی دو ماه قبل از مداخله و همزمان با اجرای مداخله تا مدت زمان پیگیری، یکسان بودن گروه دارویی مورد استفاده همراه با تنظیم دز. معیارهای عدم ورود: سایکوز، خطر خودکشی، وجود شی الکتریکی در بدن، سابقه ی تشنج، بارداری، اختلال دوقطبی همبود
General information
32
40
3240
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Increasing the sample size and adding follow-up three months after treatment
Increasing the sample size and adding follow-up three months after treatment
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افزایش تعداد افراد نمونه و اضافه کردن پیگیری سه ماه بعد از درمان
افزایش تعداد افراد نمونه و اضافه کردن پیگیری سه ماه بعد از درمان
Risk of suicide
psychosis
Existence a history of seizures and epilepsy
The presence of an electrical or metallic object in the body
Diagnosis of any neurological conditions that affects the central nervous system. (like Parkinson's)
pregnancy
Risk of suicide
psychosis
Existence a history of seizures and epilepsy
The presence of an electrical or metallic object in the body
Diagnosis of any neurological conditions that affects the central nervous system. (like Parkinson's)
pregnancy
Comorbid bipolar disorder
Risk of suicide psychosis Existence a history of seizures and epilepsy The presence of an electrical or metallic object in the body Diagnosis of any neurological conditions that affects the central nervous system. (like Parkinson's) pregnancy Comorbid bipolar disorder
خطر خودکشی
سایکوز
داشتن سابقه تشنج و صرع
وجود شیء الکتریکی یا فلزی در بدن
وجود هر بیماری عصب شناختی که بر سیستم عصبی مرکزی تاثیر میگذارد. (مثل پارکینسون)
بارداری
خطر خودکشی
سایکوز
داشتن سابقه تشنج و صرع
وجود شیء الکتریکی یا فلزی در بدن
وجود هر بیماری عصب شناختی که بر سیستم عصبی مرکزی تاثیر میگذارد. (مثل پارکینسون)
بارداری
اختلال دوقطبی همبود
خطر خودکشی سایکوز داشتن سابقه تشنج و صرع وجود شیء الکتریکی یا فلزی در بدن وجود هر بیماری عصب شناختی که بر سیستم عصبی مرکزی تاثیر میگذارد. (مثل پارکینسون) بارداری اختلال دوقطبی همبود
The samples are randomly assigned to the intervention and sham groups. Random allocation is done using Excel software. For this, in the first column, we enter 16 numbers 1 and 16 numbers 2 representing the real intervention group and the sham intervention group, respectively. Then, in the second column, we generate 32 random numbers using the (RAND) function. We sort the data based on column values containing random numbers (ascending or descending). With this sorting, the order of placement of numbers 1 and 2 will also change and be placed randomly. Based on the order of appearance of numbers 1 and 2, the samples are assigned to two groups.
The samples are randomly assigned to the intervention and sham groups. Random allocation is done using Excel software. For this, in the first column, we enter 20 numbers 1 and 20 numbers 2 representing the real intervention group and the sham intervention group, respectively. Then, in the second column, we generate 40 random numbers using the (RAND) function. We sort the data based on column values containing random numbers (ascending or descending). With this sorting, the order of placement of numbers 1 and 2 will also change and be placed randomly. Based on the order of appearance of numbers 1 and 2, the samples are assigned to two groups.
The samples are randomly assigned to the intervention and sham groups. Random allocation is done using Excel software. For this, in the first column, we enter 1620 numbers 1 and 1620 numbers 2 representing the real intervention group and the sham intervention group, respectively. Then, in the second column, we generate 3240 random numbers using the (RAND) function. We sort the data based on column values containing random numbers (ascending or descending). With this sorting, the order of placement of numbers 1 and 2 will also change and be placed randomly. Based on the order of appearance of numbers 1 and 2, the samples are assigned to two groups.
نمونه ها در دو گروه مداخله و شم بصورت گمارش تصادفی وارد میشوند. تخصیص تصادفی با استفاده از نرم‌افزار Excel انجام می‌شود. برای این کار، در ستون اول 16 عدد 1 و 16 عدد 2 به‌ترتیب نشان‌دهنده گروه مداخله ی واقعی و مداخله ی شم وارد می‌کنیم. سپس در ستون دوم با استفاده از تابع(RAND) ،32 عدد تصادفی تولید می‌کنیم. داده‌ها را بر اساس مقادیر ستون شامل اعداد تصادفی مرتب (به‌صورت صعودی یا نزولی) می‌کنیم. با این مرتب‌سازی، ترتیب قرار گرفتن اعداد 1 و 2 نیز تغییر می‌کنند و به‌صورت تصادفی قرار می‌گیرند. بر اساس ترتیب ظهور اعداد 1 و 2، نمونه‌ها به دو گروه تخصیص می‌یابند.
نمونه ها در دو گروه مداخله و شم بصورت گمارش تصادفی وارد میشوند. تخصیص تصادفی با استفاده از نرم‌افزار Excel انجام می‌شود. برای این کار، در ستون اول 20 عدد 1 و 20 عدد 2 به‌ترتیب نشان‌دهنده گروه مداخله ی واقعی و مداخله ی شم وارد می‌کنیم. سپس در ستون دوم با استفاده از تابع(RAND) ،40 عدد تصادفی تولید می‌کنیم. داده‌ها را بر اساس مقادیر ستون شامل اعداد تصادفی مرتب (به‌صورت صعودی یا نزولی) می‌کنیم. با این مرتب‌سازی، ترتیب قرار گرفتن اعداد 1 و 2 نیز تغییر می‌کنند و به‌صورت تصادفی قرار می‌گیرند. بر اساس ترتیب ظهور اعداد 1 و 2، نمونه‌ها به دو گروه تخصیص می‌یابند.
نمونه ها در دو گروه مداخله و شم بصورت گمارش تصادفی وارد میشوند. تخصیص تصادفی با استفاده از نرم‌افزار Excel انجام می‌شود. برای این کار، در ستون اول 1620 عدد 1 و 1620 عدد 2 به‌ترتیب نشان‌دهنده گروه مداخله ی واقعی و مداخله ی شم وارد می‌کنیم. سپس در ستون دوم با استفاده از تابع(RAND) ،3240 عدد تصادفی تولید می‌کنیم. داده‌ها را بر اساس مقادیر ستون شامل اعداد تصادفی مرتب (به‌صورت صعودی یا نزولی) می‌کنیم. با این مرتب‌سازی، ترتیب قرار گرفتن اعداد 1 و 2 نیز تغییر می‌کنند و به‌صورت تصادفی قرار می‌گیرند. بر اساس ترتیب ظهور اعداد 1 و 2، نمونه‌ها به دو گروه تخصیص می‌یابند.
Primary outcomes
#1
Measuring the severity of obsessive-compulsive symptoms before the intervention, immediately after the end of the intervention, follow-up two weeks and four weeks after the end of the intervention
Measuring the severity of obsessive-compulsive symptoms before the intervention, immediately after the intervention, two weeks, four weeks, and three months after the intervention as follow-up periods
Measuring the severity of obsessive-compulsive symptoms before the intervention, immediately after the end ofintervention, two weeks, four weeks, and three months after the intervention, as follow-up two weeks and four weeks after the end of the interventionperiods
اندازه گیری شدت علائم وسواسی-جبری قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته و چهار هفته بعد از اتمام مداخله
اندازه گیری شدت علائم وسواسی-جبری قبل از مداخله، بلافاصله بعد از اتمام مداخله، دوهفته، چهار هفته و سه ماه بعد از اتمام مداخله بعنوان پیگیری
اندازه گیری شدت علائم وسواسی-جبری قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته و، چهار هفته و سه ماه بعد از اتمام مداخله بعنوان پیگیری
#2
Measuring the level of depression before the intervention, immediately after the end of the intervention, follow-up two weeks and four weeks after the end of the intervention
Measurement of depression levels before the intervention, immediately after the intervention, and two-week, four-week, and three-month follow-up periods after the intervention.
Measuring the levelMeasurement of depression levels before the intervention, immediately after the end of the intervention, and two-week, four-week, and three-month follow-up two weeks and four weeksperiods after the end of the intervention.
اندازه گیری میزان افسردگی قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته و چهار هفته بعد از اتمام مداخله
اندازه گیری میزان افسردگی قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته، چهار هفته و سه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
اندازه گیری میزان افسردگی قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته و، چهار هفته و سه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
#3
Measuring the level of anxiety before the intervention, immediately after the end of the intervention, follow-up two weeks and four weeks after the end of the intervention
Measurement of anxiety levels before the intervention, immediately after the intervention, and two-week, four-week, and three-month follow-up periods after the intervention.
Measuring the levelMeasurement of anxiety levels before the intervention, immediately after the end of the intervention, and two-week, four-week, and three-month follow-up two weeks and four weeksperiods after the end of the intervention.
اندازه گیری میزان اضطراب قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته و چهار هفته بعد از اتمام مداخله
اندازه گیری میزان اضطراب قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته، چهار هفته و سه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
اندازه گیری میزان اضطراب قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته و، چهار هفته و سه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
Secondary outcomes
#1
Measuring the individual's score in the task of Spatial Working Memory (SWM) before the intervention, immediately after the end of the intervention, two-week and four-week follow-up after the end of the intervention
Measuring the individual's score in the task of Spatial Working Memory (SWM) before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods.
Measuring the individual's score in the task of Spatial Working Memory (SWM) before the intervention, immediatelyImmediately after the end of the intervention, two-week weeks, four weeks, and four-week follow-upthree months after the end of the intervention as follow-up periods.
اندازه گیری نمره ی فرد در تکلیف Spatial Working Memory (SWM) قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته و چهارهفته بعد از اتمام مداخله
اندازه گیری نمره ی فرد در تکلیف Spatial Working Memory (SWM) قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته، چهارهفته و سه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
اندازه گیری نمره ی فرد در تکلیف Spatial Working Memory (SWM) قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته، چهارهفته و چهارهفتهسه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
#2
Measuring the individual's score in the Stop Signal Task (SST) task before the intervention, immediately after the end of the intervention, two-week and four-week follow-up after the end of the intervention
Measuring the individual's score in the Stop Signal Task (SST) task before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods.
Measuring the individual's score in the Stop Signal Task (SST) task before the intervention, immediatelyImmediately after the end of the intervention, two-week weeks, four weeks, and four-week follow-upthree months after the end of the intervention as follow-up periods.
اندازه گیری نمره ی فرد در تکلیف Stop Signal Task (SST) قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته و چهارهفته بعد از اتمام مداخله
اندازه گیری نمره ی فرد در تکلیف Stop Signal Task (SST) قبل از مداخله، بلافاصله بعد از اتمام مداخله، دوهفته، چهارهفته و سه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
اندازه گیری نمره ی فرد در تکلیف Stop Signal Task (SST) قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته، چهارهفته و چهارهفتهسه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
#3
Measuring the individual's score in the Intra-Extra Dimensional Set Shift (IED) task before the intervention, immediately after the end of the intervention, two-week and four-week follow-up after the end of the intervention
Measuring the individual's score in the Intra-Extra Dimensional Set Shift (IED) task before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods.
Measuring the individual's score in the Intra-Extra Dimensional Set Shift (IED) task before the intervention, immediatelyImmediately after the end of the intervention, two-week weeks, four weeks, and four-week follow-upthree months after the end of the intervention as follow-up periods.
اندازه گیری نمره ی فرد در تکلیف Intra-Extra Dimensional Set Shift (IED) قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته و چهارهفته بعد از اتمام مداخله
اندازه گیری نمره ی فرد در تکلیف Intra-Extra Dimensional Set Shift (IED) قبل از مداخله، بلافاصله بعد از اتمام مداخله، دوهفته، چهارهفته و سه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
اندازه گیری نمره ی فرد در تکلیف Intra-Extra Dimensional Set Shift (IED) قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته، چهارهفته و چهارهفتهسه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
#4
Measuring the individual's score in the Paired Associates Learning task before the intervention, immediately after the intervention, two-week and four-week follow-up after the intervention.
Measuring the individual's score in the Paired Associates Learning task before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods.
Measuring the individual's score in the Paired Associates Learning task before the intervention, immediatelyImmediately after the end of the intervention, two-week weeks, four weeks, and four-weekthree months after the end of the intervention as follow-up after the interventionperiods.
اندازه گیری نمره ی فرد در تکلیف Paired Associates Learning قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته و چهارهفته بعد از اتمام مداخله
اندازه گیری نمره ی فرد در تکلیف Paired Associates Learning قبل از مداخله، بلافاصله بعد از اتمام مداخله، دوهفته، چهارهفته و سه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
اندازه گیری نمره ی فرد در تکلیف Paired Associates Learning قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته، چهارهفته و چهارهفتهسه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
#5
Measuring the individual's score in the Rapid Visual Information Processing task before the intervention, immediately after the intervention, two-week and four-week follow-up after the intervention.
Measuring the individual's score in the Rapid Visual Information Processing task before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods.
Measuring the individual's score in the Rapid Visual Information Processing task before the intervention, immediatelyImmediately after the end of the intervention, two-week weeks, four weeks, and four-weekthree months after the end of the intervention as follow-up after the interventionperiods.
اندازه گیری نمره ی فرد در تکلیف Rapid Visual Information Processing قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته و چهارهفته بعد از اتمام مداخله
اندازه گیری نمره ی فرد در تکلیف Rapid Visual Information Processing قبل از مداخله، بلافاصله بعد از اتمام مداخله، دوهفته، چهارهفته و سه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
اندازه گیری نمره ی فرد در تکلیف Rapid Visual Information Processing قبل از مداخله، بلافاصله بعد از اتمام مداخله، پیگیری دوهفته، چهارهفته و چهارهفتهسه ماه بعد از اتمام مداخله بعنوان دوره های پیگیری
Protocol summary
Study aim
Determining the effectiveness of applying the 3mA TDCS protocol in the right lower frontal and left supraorbital regions on cognitive functions, depression, anxiety, and severity of obsessive-compulsive symptoms in people with OCD
Design
A controlled, parallel-group, double-blind, randomized clinical trial on 40 patients. Simple randomization was used.
Settings and conduct
This research will be carried out in the Beheshti hospital clinic in Zanjan with direct current transcranial electrical stimulation for 20 sessions in 10 days.
Participants/Inclusion and exclusion criteria
Having the full diagnostic criteria for obsessive-compulsive disorder as diagnosed by a psychiatrist and psychologist based on the diagnostic and statistical manual of mental disorders, age range 18 to 50 years, not receiving psychological treatment two months before the intervention, and simultaneously with the implementation of the intervention until the follow-up period, the same Being the drug group used along with adjusting the dose. Inclusion criteria: psychosis, risk of suicide, presence of electrical objects in the body, history of seizures, pregnancy, Comorbid bipolar disorder
Intervention groups
According to the desired protocol, the patients of the intervention group will receive real stimulation with an intensity of 3 milliamps for twenty sessions of 20 minutes in ten days, with the anode placed in the right area of the lower frontal cortex and the cathode on the left supraorbital area. And the sham group will also receive sham stimulation for the same number of sessions in these areas.
Main outcome variables
Clinical symptoms of obsessive-compulsive disorder, working memory, cognitive inhibition, cognitive flexibility, visual memory, sustained attention, depression, anxiety
General information
Reason for update
Increasing the sample size and adding follow-up three months after treatment
Acronym
IRCT registration information
IRCT registration number:IRCT20230216057437N1
Registration date:2023-03-31, 1402/01/11
Registration timing:prospective
Last update:2025-03-06, 1403/12/16
Update count:1
Registration date
2023-03-31, 1402/01/11
Registrant information
Name
Atefeh Fatehi chenar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3411 1292
Email address
fatehi.atefe@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of 3MA transcranial direct current stimulation (TDCS) on cognitive function, depression, anxiety and severity of obsessive-compulsive symptoms in individuals with OCD: A randomized clinical trial
Public title
The Effectiveness of 3MA transcranial direct current stimulation (TDCS) on cognitive function, depression, anxiety and severity of obsessive-compulsive symptoms in individuals with OCD: A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having complete OCD diagnostic criteria as diagnosed by a psychiatrist and psychologist based on DSM-5
Having at least a third middle school education
Age range between 18-50 years
Sign the written consent
Not receiving psychological treatment two months before the intervention and simultaneously with the implementation of the intervention until the follow-up period
The same drug group was used along with dose adjustment
Exclusion criteria:
Risk of suicide
psychosis
Existence a history of seizures and epilepsy
The presence of an electrical or metallic object in the body
Diagnosis of any neurological conditions that affects the central nervous system. (like Parkinson's)
pregnancy
Comorbid bipolar disorder
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly assigned to the intervention and sham groups. Random allocation is done using Excel software. For this, in the first column, we enter 20 numbers 1 and 20 numbers 2 representing the real intervention group and the sham intervention group, respectively. Then, in the second column, we generate 40 random numbers using the (RAND) function. We sort the data based on column values containing random numbers (ascending or descending). With this sorting, the order of placement of numbers 1 and 2 will also change and be placed randomly. Based on the order of appearance of numbers 1 and 2, the samples are assigned to two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The people under study do not know the type of intervention. Both the researcher and the evaluator are unaware of the type of intervention. The device is set by one of the clinic staff on real or sham intervention and the patient receives a code based on that. The people who analyze the results do not know the nature of the study groups and the evaluation is done by someone other than the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethnics committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences , Mahdavi Blv, shahrak karmandan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2023-02-16, 1401/11/27
Ethics committee reference number
IR.ZUMS.REC.1401.339
Health conditions studied
1
Description of health condition studied
Obsessive-Compulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
The person's score on the Yale-Brown Obsessive-Compulsive Scale
Timepoint
Measuring the severity of obsessive-compulsive symptoms before the intervention, immediately after the intervention, two weeks, four weeks, and three months after the intervention as follow-up periods
Method of measurement
Yale-Brown Obsessive-Compulsive Scale
2
Description
Individual's score in Beck depression questionnaire
Timepoint
Measurement of depression levels before the intervention, immediately after the intervention, and two-week, four-week, and three-month follow-up periods after the intervention.
Method of measurement
Beck depression inventory
3
Description
Individual's score in Beck's anxiety inventory
Timepoint
Measurement of anxiety levels before the intervention, immediately after the intervention, and two-week, four-week, and three-month follow-up periods after the intervention.
Method of measurement
Beck's anxiety inventory
Secondary outcomes
1
Description
The score of a person's working memory in the task of Spatial Working Memory (SWM) from Cambridge Neuropsychological Test Automated Battery (CANTAB)
Timepoint
Measuring the individual's score in the task of Spatial Working Memory (SWM) before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods.
Method of measurement
the Spatial Working Memory (SWM) task from CANTAB
2
Description
A person's cognitive inhibition score in the Stop Signal Task (SST) from CANTAB
Timepoint
Measuring the individual's score in the Stop Signal Task (SST) task before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods.
Method of measurement
the Stop Signal Task (SST) from CANTAB
3
Description
The score of the person's cognitive flexibility in the Intra-Extra Dimensional Set Shift (IED) task from CANTAB
Timepoint
Measuring the individual's score in the Intra-Extra Dimensional Set Shift (IED) task before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods.
Method of measurement
the Intra-Extra Dimensional Set Shift (IED) task from CANTAB
4
Description
A person's visual memory score in the Paired Associates Learning assignment from CANTAB
Timepoint
Measuring the individual's score in the Paired Associates Learning task before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods.
Method of measurement
the Paired Associates Learning assignment from CANTAB
5
Description
The score of a person's sustained attention in the task of Rapid Visual Information Processing from CANTAB
Timepoint
Measuring the individual's score in the Rapid Visual Information Processing task before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods.
Method of measurement
the task of Rapid Visual Information Processing from CANTAB
Intervention groups
1
Description
Intervention group: Twenty sessions of 20 minutes in ten days under real stimulation with an intensity of 3 milliamperes, with the anode placed on the right area of the inferior frontal cortex and the cathode on the left supraorbital area.
Category
Treatment - Devices
2
Description
Control group: Twenty sessions of 20 minutes in ten days under sham stimulation with an intensity of 3 milliamperes, with the anode placed on the right area of the inferior frontal cortex and the cathode on the left supraorbital area.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Beheshti Hospital Clinic
Full name of responsible person
Atefeh Fatehi chenar
Street address
Ark Square, Shahid Beheshti Therapeutic and Psychiatric Education Center
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
fatehi.atefe@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hasan Bakhtiary
Street address
Zanjan University of Medical Science, Mahdavi Blv, Shahrak Karmandan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8100
Email
hbakhtiary@zums.ac.ir
Web page address
http://zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Atefeh Fatehi chenar
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ark Square, Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8100
Email
atefehfatehi993@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Atefeh Fatehi chenar
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ark Gate, Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
1578845136
Phone
+98 24 3354 4001
Email
atefehfatehi993@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Atefeh Fatehi chenar
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ark Gate, Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
1578845136
Phone
+98 24 3354 4001
Email
atefehfatehi993@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available