Comparison of the Effectiveness of Combined Transcranial Direct Current Stimulation (tDCS) with Pharmacotherapy and Pharmacotherapy on Depression, Emotion Regulation, Response Inhibition, Problem Solving in Patients with Bipolar Disorders
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General information
Not blinded
Double blinded
notbldoubl
1
1
1
1
empty
The present study was performed in a double-blind type and the researcher considered it necessary to update it.
The present study was performed in a double-blind type and the researcher considered it necessary to update it.
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پژوهش حاضر از نوع دوسویه کور اجرا شد و محقق از این جهت بروزرسانی را لازم دید.
پژوهش حاضر از نوع دوسویه کور اجرا شد و محقق از این جهت بروزرسانی را لازم دید.
In this study, the evaluator and the therapist are separated and blinded, so that the therapist does not know how to evaluate and they are separated from each other.
In this study, the evaluator and the therapist are separated and blinded, so that the therapist does not know how to evaluate and they are separated from each other.
ارزیاب و درمانگر در این مطالعه جدا هستند و کور شده اند، به گونه ای که درمانگر از نحوه ارزیابی اطلاعی ندارد و از هم دیگر تفکیک شده اند.
ارزیاب و درمانگر در این مطالعه جدا هستند و کور شده اند، به گونه ای که درمانگر از نحوه ارزیابی اطلاعی ندارد و از هم دیگر تفکیک شده اند.
Recruitment centers
#1
Name of recruitment center - English: بیمارستان شهید بهشتی
Name of recruitment center - Persian: Shahid Beheshti Hospital
Full name of responsible person - English: سیده الناز موسوی
Full name of responsible person - Persian: Seyedeh E lnaz Mousavi
Street address - English: Zanjan- Ark Square- Shahid Beheshti Hospital- Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi
Street address - Persian: زنجان- میدان ارک- بیمارستان شهید بهشتی- دپارتمان روانشناسی بالینی- دکتر سیده الناز موسوی
City - English: Znajan
City - Persian: زنجان
Province: Zanjan
Country: Iran (Islamic Republic of)
Postal code: 1456287358
Phone: +98 24 3353 4500
Fax:
Email: Dr.Emousavi@zums.ac.ir
Web page address:
Name of recruitment center - English: Shahid Beheshti Hospital
Name of recruitment center - Persian: بیمارستان شهید بهشتی
Full name of responsible person - English: Seyedeh Elnaz Mousavi
Full name of responsible person - Persian: سیده الناز موسوی
Street address - English: Zanjan- Ark Square- Shahid Beheshti Hospital- Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi
Street address - Persian: زنجان- میدان ارک- بیمارستان شهید بهشتی- دپارتمان روانشناسی بالینی- دکتر سیده الناز موسوی
City - English: Znajan
City - Persian: زنجان
Province: Zanjan
Country: Iran (Islamic Republic of)
Postal code: 1456287358
Phone: +98 24 3353 4500
Fax:
Email: Dr.Emousavi@zums.ac.ir
Web page address:
Name of recruitment center - English: بیمارستان شهید بهشتیShahid Beheshti Hospital Name of recruitment center - Persian: Shahid Beheshti Hospitalبیمارستان شهید بهشتی Full name of responsible person - English: سیده الناز موسویSeyedeh Elnaz Mousavi Full name of responsible person - Persian: Seyedeh E lnaz Mousaviسیده الناز موسوی Street address - English: Zanjan- Ark Square- Shahid Beheshti Hospital- Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi Street address - Persian: زنجان- میدان ارک- بیمارستان شهید بهشتی- دپارتمان روانشناسی بالینی- دکتر سیده الناز موسوی City - English: Znajan City - Persian: زنجان Province: Zanjan Country: Iran (Islamic Republic of) Postal code: 1456287358 Phone: +98 24 3353 4500 Fax: Email: Dr.Emousavi@zums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyed Elnaz Mousavi
Full name of responsible person - Persian: سیده الناز موسوی
Street address - English: Zanjan- Ark Square- Shahid Beheshti Hospital- Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi
Street address - Persian: زنجان- میدان ارک- بیمارستان شهید بهشتی- دپارتمان روانشناسی بالینی- دکتر سیده الناز موسوی
City - English: Zanjan
City - Persian: زنجان
Province: Zanjan
Country: Iran (Islamic Republic of)
Postal code: 1445868971
Phone: +98 24 3353 4500
Fax:
Email: Dr.Emousavi@zums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Deputy of Research and Research Zanjan University of Medical Sciences.
Name of organization / entity - Persian: معاونت تحقیقات و پزوهش دانشگاه علوم پزشکی زنجان
Full name of responsible person - English: Dr Alireza Shoghli
Full name of responsible person - Persian: دکتر علیرضا شغلی
Street address - English: Zanjan- Ark Square- Shahid Beheshti Hospital- Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi
Street address - Persian: زنجان- میدان ارک- بیمارستان شهید بهشتی- دپارتمان روانشناسی بالینی- دکتر سیده الناز موسوی
City - English: Zanjan
City - Persian: زنجان
Province: Zanjan
Country: Iran (Islamic Republic of)
Postal code: 1445868971
Phone: +98 24 3353 4500
Fax:
Email: Dr.Emousavi@zums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Deputy of Research and Research Zanjan University of Medical Sciences. Name of organization / entity - Persian: معاونت تحقیقات و پزوهش دانشگاه علوم پزشکی زنجان Full name of responsible person - English: Seyed Elnaz MousaviDr Alireza Shoghli Full name of responsible person - Persian: سیده الناز موسویدکتر علیرضا شغلی Street address - English: Zanjan- Ark Square- Shahid Beheshti Hospital- Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi Street address - Persian: زنجان- میدان ارک- بیمارستان شهید بهشتی- دپارتمان روانشناسی بالینی- دکتر سیده الناز موسوی City - English: Zanjan City - Persian: زنجان Province: Zanjan Country: Iran (Islamic Republic of) Postal code: 1445868971 Phone: +98 24 3353 4500 Fax: Email: Dr.Emousavi@zums.ac.ir Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyedeh Elnaz Mousavi
Full name of responsible person - Persian: سیده الناز موسوی
Position - English: Associate professor
Position - Persian: استادیار،
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Zanjan- Ark Square- Shahid Beheshti Hospital- Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi
Street address - Persian: زنجان- میدان ارک- بیمارستان شهید بهشتی- دپارتمان روانشناسی بالینی- دکتر سیده الناز موسوی
City - English: Zanjan
City - Persian: زنجان
Province: Zanjan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1452687818
Phone: +98 24 3353 4500
Mobile: +98 910 203 3247
Fax:
Email: Dr.Emousavi@zums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyedeh Elnaz Mousavi
Full name of responsible person - Persian: سیده الناز موسوی
Position - English: Associate professor
Position - Persian: استادیار،
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ark Square, Shahid Beheshti Hospital, Department of Clinical Psychology, Zanjan, Iran
Street address - Persian: ایران، زنجان، میدان ارک، بیمارستان شهید بهشتی، دپارتمان روانشناسی بالینی
City - English: Zanjan
City - Persian: زنجان
Province: Zanjan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1452687818
Phone: +98 24 3353 4500
Mobile: +98 910 203 3247
Fax:
Email: Dr.Emousavi@zums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Seyedeh Elnaz Mousavi Full name of responsible person - Persian: سیده الناز موسوی Position - English: Associate professor Position - Persian: استادیار، Latest degree: phd Area of specialty/work: 48 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Zanjan- Ark Square-, Shahid Beheshti Hospital-, Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi, Zanjan, Iran Street address - Persian: ایران، زنجان-، میدان ارک-، بیمارستان شهید بهشتی-، دپارتمان روانشناسی بالینی- دکتر سیده الناز موسوی City - English: Zanjan City - Persian: زنجان Province: Zanjan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1452687818 Phone: +98 24 3353 4500 Mobile: +98 910 203 3247 Fax: Email: Dr.Emousavi@zums.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyedeh Elnaz Mousavi
Full name of responsible person - Persian: سیده الناز موسوی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Zanjan- Ark Square- Shahid Beheshti Hospital- Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi
Street address - Persian: زنجان- میدان ارک- بیمارستان شهید بهشتی- دپارتمان روانشناسی بالینی- دکتر سیده الناز موسوی
City - English: Zanjan
City - Persian: زنجان
Province: Zanjan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1452368712
Phone: +98 24 3353 4500
Mobile: +98 910 203 3247
Fax:
Email: Dr.Emousavi@zums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyedeh Elnaz Mousavi
Full name of responsible person - Persian: سیده الناز موسوی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ark Square, Shahid Beheshti Hospital, Department of Clinical Psychology, Zanjan, Iran
Street address - Persian: ایران، زنجان، میدان ارک، بیمارستان شهید بهشتی، دپارتمان روانشناسی بالینی
City - English: Zanjan
City - Persian: زنجان
Province: Zanjan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1452368712
Phone: +98 24 3353 4500
Mobile: +98 910 203 3247
Fax:
Email: Dr.Emousavi@zums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Seyedeh Elnaz Mousavi Full name of responsible person - Persian: سیده الناز موسوی Position - English: Associate professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 48 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Zanjan- Ark Square-, Shahid Beheshti Hospital-, Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi, Zanjan, Iran Street address - Persian: ایران، زنجان-، میدان ارک-، بیمارستان شهید بهشتی-، دپارتمان روانشناسی بالینی- دکتر سیده الناز موسوی City - English: Zanjan City - Persian: زنجان Province: Zanjan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1452368712 Phone: +98 24 3353 4500 Mobile: +98 910 203 3247 Fax: Email: Dr.Emousavi@zums.ac.ir Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyedeh Elnaz Mousavi
Full name of responsible person - Persian: سیده الناز موسوی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Zanjan- Ark Square- Shahid Beheshti Hospital- Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi
Street address - Persian: زنجان- میدان ارک- بیمارستان شهید بهشتی- دپارتمان روانشناسی بالینی- دکتر سیده الناز موسوی
City - English: Zanjan
City - Persian: زنجان
Province: Zanjan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1453257924
Phone: +98 24 3353 4500
Mobile: +98 910 203 3247
Fax:
Email: Dr.Emousavi@zums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyedeh Elnaz Mousavi
Full name of responsible person - Persian: سیده الناز موسوی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ark Square, Shahid Beheshti Hospital, Department of Clinical Psychology, Zanjan, Iran
Street address - Persian: ایران، زنجان، میدان ارک، بیمارستان شهید بهشتی، دپارتمان روانشناسی بالینی
City - English: Zanjan
City - Persian: زنجان
Province: Zanjan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1453257924
Phone: +98 24 3353 4500
Mobile: +98 910 203 3247
Fax:
Email: Dr.Emousavi@zums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Seyedeh Elnaz Mousavi Full name of responsible person - Persian: سیده الناز موسوی Position - English: Associate professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 48 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Zanjan- Ark Square-, Shahid Beheshti Hospital-, Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi, Zanjan, Iran Street address - Persian: ایران، زنجان-، میدان ارک-، بیمارستان شهید بهشتی-، دپارتمان روانشناسی بالینی- دکتر سیده الناز موسوی City - English: Zanjan City - Persian: زنجان Province: Zanjan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1453257924 Phone: +98 24 3353 4500 Mobile: +98 910 203 3247 Fax: Email: Dr.Emousavi@zums.ac.ir Web page address:
Protocol summary
Study aim
Comparison of the Effectiveness of Combined Transcranial Direct Current Stimulation (tDCS) with Pharmacotherapy and Pharmacotherapy on Depression, Emotion Regulation, Response Inhibition, Problem Solving in Patients with Bipolar Disorders
Design
The present study is a clinical trial with pre-test, post-test and parallel group that will be randomized.
Settings and conduct
Samples are cited by a psychiatrist as per the admission criteria and, if not included in the exclusion criteria, enter the experimental groups. Then, after obtaining informed consent to participate in the research, the Hamilton Depression Rating Scale, the Gross Emotion Regulation Questionnaire, the GO no GO test and Tower of London are presented. The tDCS treatment program is then administered to the experimental group for 10 sessions of 20 minutes.
The droge group will receive psychiatric drugs. It should be noted that the samples will not be admitted to the outpatient ward and referred to an outpatient psychiatrist's office, as well as the medications received by the psychiatrist from a medication category and in fact no significant differences in the medications as far as possible. Groups should be homogenous in this regard. After the intervention, the questionnaires and re-evaluation tests, as well as three months after the intervention, will be conducted to follow up the results. In order to prevent bias, the patient will be evaluated by someone other than the therapist.
Participants/Inclusion and exclusion criteria
Type 1 bipolar disorder with psychiatrist diagnosis
Intervention groups
Combination Transcranial Direct Current Stimulation (tDCS) with Pharmacotherapy Group.
and Pharmacotherapy Group
Main outcome variables
Depression, Emotion Regulation, Response Inhibition, Problem Solving
General information
Reason for update
The present study was performed in a double-blind type and the researcher considered it necessary to update it.
Acronym
IRCT registration information
IRCT registration number:IRCT20191229045931N1
Registration date:2020-08-24, 1399/06/03
Registration timing:retrospective
Last update:2021-10-12, 1400/07/20
Update count:2
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Elnaz Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 2689
Email address
dr.emousavi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Combined Transcranial Direct Current Stimulation (tDCS) with Pharmacotherapy and Pharmacotherapy on Depression, Emotion Regulation, Response Inhibition, Problem Solving in Patients with Bipolar Disorders
Public title
Effectiveness of Combined Transcranial Direct current Stimulation (tDCS) with Pharmacotherapy and Pharmacotherapy in Bipolar Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 1 bipolar disorder at the discretion of a psychiatrist
Willingness to participate in research
Age range minimum 18 and maximum 50 years
At least third grade education
No severe psychiatric disorders such as psychotic disorders and cognitive impairment
Lack of history of epileptic seizures and history of head injury
Failure to receive psychological and technological therapies at least one month before entering the study
Exclusion criteria:
Severe psychiatric disorders such as psychotic disorders and cognitive impairment
History of epileptic seizures and history of head injury
Consumption of drugs and alcohol
Existence of suicidal thoughts
Existence of rapid cycles of mania
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random Number Generator v1.3 program will be used to assign sample members to two experimental groups. In this way, the number of sample people is given to this software and this program randomly places each number in a group according to its function.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the evaluator and the therapist are separated and blinded, so that the therapist does not know how to evaluate and they are separated from each other.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ZanjanUniversity of Medical Sciences
Street address
Zanjan- Ark Square- Shahid Beheshti Hospital- Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi
City
Zanjan
Province
Zanjan
Postal code
1452488552
Approval date
2020-02-05, 1398/11/16
Ethics committee reference number
IR.ZUMS.REC.1398.452
Health conditions studied
1
Description of health condition studied
It is a bipolar disorder
ICD-10 code
F31.4
ICD-10 code description
Bipolar disorder, current episode depressed, severe, without psychotic features
Primary outcomes
1
Description
Depression
Timepoint
10 day and 3 month
Method of measurement
Hamilton Depression Scale
2
Description
Emotion Regulation
Timepoint
10 day and 3 month
Method of measurement
Grass emotion regulation questionnaire
3
Description
Response Inhibition
Timepoint
10 day and 3 month
Method of measurement
GO no GO test
4
Description
Problem Solving
Timepoint
10 day and 3 month
Method of measurement
the tower of London
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Combination of tDCS and medication:The tDCS treatment program was performed for 10 sessions of 20 minutes (F3) and (F4) for the experimental group. The electric current by these electrodes, after passing through different areas (scalp, skull, etc.), reaches the surface of the cerebral cortex.The current that reaches this area charges the neurons It is electrified and causes positive and negative poles, which leads to a change in the activity of that area.
Category
Treatment - Devices
2
Description
Intervention group: Medication: Mood stabilizing drugs will be prescribed by a psychiatrist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Seyedeh Elnaz Mousavi
Street address
Zanjan- Ark Square- Shahid Beheshti Hospital- Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi
City
Znajan
Province
Zanjan
Postal code
1456287358
Phone
+98 24 3353 4500
Email
Dr.Emousavi@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Research Zanjan University of Medical Sciences.
Full name of responsible person
Dr Alireza Shoghli
Street address
Zanjan- Ark Square- Shahid Beheshti Hospital- Department of Clinical Psychology- Dr. Seyedeh Elnaz Mousavi
City
Zanjan
Province
Zanjan
Postal code
1445868971
Phone
+98 24 3353 4500
Email
Dr.Emousavi@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No funding
Proportion provided by this source
1
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
Seyedeh Elnaz Mousavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ark Square, Shahid Beheshti Hospital, Department of Clinical Psychology, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
1452687818
Phone
+98 24 3353 4500
Email
Dr.Emousavi@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyedeh Elnaz Mousavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ark Square, Shahid Beheshti Hospital, Department of Clinical Psychology, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
1452368712
Phone
+98 24 3353 4500
Email
Dr.Emousavi@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyedeh Elnaz Mousavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ark Square, Shahid Beheshti Hospital, Department of Clinical Psychology, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
1453257924
Phone
+98 24 3353 4500
Email
Dr.Emousavi@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD