Protocol summary

Study aim
Determining the effectiveness of TDCS on improvement of OCD symptoms, quality of life, depression, and cognitive functions in patients with obsessive-compulsive disorder
Design
A randomized (using random numbers table), double-blind, sham controlled clinical trial with a parallel group, 30 patients (15 patients in the sham and 30 patients, 15 in each stimulation group).Both participants and evaluators will be unaware of the allocation of study groups.
Settings and conduct
The statistical population of the present study will include patients with obsessive-compulsive disorder who refer to counseling and psychotherapy centers and psychiatric clinics in Ardabil in 2020. In the stimulation groups (1 mA and 2 mA), the samples will be treated for 10 sessions. Patients will be treated daily for 20 minutes. In the sham group, no therapeutic intervention will be performed with the TDCS device. Patients in both groups will be done pre-tested, post-test and follow up before, after and one month after intervention with Yale Brown, SF-36, Beck-II, Wisconsin cards and QEEG. Control group will be treated with tdcs for 10 sessions after the end of trial.
Participants/Inclusion and exclusion criteria
The research samples will include 45 patients with obsessive-compulsive disorder who will be selected based on the study inclusion/exclusion criteria. Inclusion criteria:Age 18 to 40, literacy to read and write, OCD according to DSM-5 criteria, Willingness to participate in the study Exclusion criteria: Severe mental illness, History of stroke, serious neurologic symptoms including seizures, Brain Surgery, Brain tumor, CSF shunt in the brain, snail planting, physical tools in the body, serious physical illness,
Intervention groups
15 in the 1 mA group, 15 in the 2 mA group and 15 in the sham group.
Main outcome variables
Improvement of OCD symptoms, quality of life, depression, and cognitive functions in patients with OCD disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200518047492N1
Registration date: 2020-08-17, 1399/05/27
Registration timing: registered_while_recruiting

Last update: 2020-08-17, 1399/05/27
Update count: 0
Registration date
2020-08-17, 1399/05/27
Registrant information
Name
Behnam Molaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 5044
Email address
b.molaei@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of trancecranial direct current stimulation (TDCS) on improvement of obsessive compulsive symptoms, quality of life, depression, and cognitive functions in patients with obsessive-compulsive disorder: A QEEG-Based Study
Public title
Effects of TDCS on improvement of obsessive compulsive symptoms in patients with obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 40 literacy to read and write OCD according to DSM-5 criteria Willingness to participate in the study
Exclusion criteria:
severe mental illness, History of stroke, serious neurologic symptoms including seizures, Brain Surgery, Brain tumor, CSF shunt in the brain, snail planting, physical tools in the body, serious physical illness
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
For small studies, random numbers can be used to sort individuals into groups. Persons participating in the research will be given a code or machine number in order to use the random or random numbers table. Since the number of people we want will be selected from 45 people, so the assigned codes and numbers will be double digits. To select sample people from the table, it will randomly start from a table point in the row or column direction. Subjects are then randomly assigned to one of three study groups (1 mA, 2mA and sham) using the random number table and receive intervention in the same group. Each of the 45 selected individuals will be assigned a code between 01 and 45. Because the volume is two digits, 2 digits out of 5 digits (2 digits to the right) will be selected from the random number table, excluding numbers greater than 45 and duplicates. After three groups of 15 are formed, they will be randomly replaced in the 1 mA, 2 mA and sham groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, first the objectives of the study and a whole explanation will be described to the participants and informed consent will be obtained from the participants. None of the participants and evaluators will be aware of the type of stimulation (1 mA, 2 mA and dummy stimulation).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Daneshgah St. Ardabil University of Medical Sciences, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹۸۵۹۹۱
Approval date
2020-05-11, 1399/02/22
Ethics committee reference number
IR.ARUMS.REC.1399.102

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
obsessive compulsive symptoms
Timepoint
Before the intervention, after the intervention and one months after the intervention
Method of measurement
Yale Brown Questionnaire

2

Description
quality of life
Timepoint
Before the intervention, after the intervention and one months after the intervention
Method of measurement
quality of life Questionnaire

3

Description
Depression
Timepoint
Before the intervention, after the intervention and one months after the intervention
Method of measurement
Beck-II Questionnaire

4

Description
cognitive functions
Timepoint
Before the intervention, after the intervention and one months after the intervention
Method of measurement
Wisconsin cards

5

Description
Quantitative Electroencephalographic Changes (QEEG)
Timepoint
Before the intervention, after the intervention and one months after the intervention
Method of measurement
Quantitative Electroencephalographic

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Electrical stimulation for 20 minutes at an intensity of 1 mA.
Category
Treatment - Devices

2

Description
Intervention group: Electrical stimulation for 20 minutes at an intensity of 2 mA.
Category
Treatment - Devices

3

Description
Control group: Sham stimulation for 20 minutes
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Counseling and psychotherapy centers and psychiatric clinics in Ardabil
Full name of responsible person
Dr Behnam Molaei
Street address
Daneshgah St. Ardabil University of Medical Sciences, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹۸۵۹۹۱
Phone
+98 45 3372 8005
Fax
+98 45 3372 8005
Email
b.molaei@arums.ac.ir
Web page address
http://arums.ac.ir/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Behnam Molaei
Street address
Daneshgah St. Ardabil Uni of Med Sci
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹۸۵۹۹۱
Phone
+98 45 3353 4790
Fax
+98 45 3353 4773
Email
molaei.b@arums.ac.ir
Web page address
http://arums.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr Behnam Molaei
Position
Assist Prof
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Daneshgah St. Ardabil University of Medical Sciences, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹۸۵۹۹۱
Phone
+98 45 3372 8005
Fax
+98 45 3372 8005
Email
b.molaei@arums.ac.ir
Web page address
http://arums.ac.ir/fa

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Behnam Molaei
Position
Assist Prof
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Daneshgah St. Ardabil University of Medical Sciences, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹۸۵۹۹۱
Phone
+98 45 3372 8005
Fax
+98 45 3372 8005
Email
b.molaei@arums.ac.ir
Web page address
http://arums.ac.ir/fa

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Behnam Molaei
Position
Assist Prof
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Daneshgah St. Ardabil University of Medical Sciences, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹۸۵۹۹۱
Phone
+98 45 3372 8005
Fax
+98 45 3372 8005
Email
b.molaei@arums.ac.ir
Web page address
http://arums.ac.ir/fa

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Publication of results of the articles in journals with international indexes
When the data will become available and for how long
no limit
To whom data/document is available
no limit
Under which criteria data/document could be used
no limit
From where data/document is obtainable
Dr Behnam Molaei
What processes are involved for a request to access data/document
b.molaei@arums.ac.ir
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