IRCT | Comparison of the effectiveness of Transcranial direct current stimulation (tDCS) and treatment based on emotion regulation in improving executive functions and cognitive functions of students with major depression in Zanjan city in 1402: a double-blind clinical trial.

Protocol summary

Study aim: Comparison of the effectiveness of Transcranial direct current stimulation (tDCS) and treatment based on emotion regulation in improving executive functions and cognitive functions of students with major depression.
Design: A clinical trial with a control group and a sham group, with a parallel group, double-blind, randomized, phase 3 on 68 patients with the randomization method of coin tossing.
Settings and conduct: This research will be conducted in Shahid Beheshti Hospital affiliated with Zanjan University of Medical Sciences. The subjects of the 4 groups will be evaluated with a structured interview and Beck depression test and questionnaires of difficulty in emotion regulation, continuous performance test, inhibitory control test, Wisconsin test, mind reading test through the eyes, and the Tower of Hanoi test. then the treatment program of Transcranial direct current stimulation (tDCS) for 10 sessions of 20 minutes for two groups; The first group will be L-DLPFC (left anode/right cathode), the second group will be Sham-tDCS. For the third group, emotion regulation treatment based on the Grass protocol will be performed for 8 sessions. The fourth group will be the control group and will not receive any intervention.
Participants/Inclusion and exclusion criteria: Entry criteria 1- Having informed consent to participate in the research 2- Having major depressive disorder 3- Being a student 4- Being at least 18 and at most 40 years old 5- Not taking psychiatric drugs 6- Having other severe psychiatric disorders Exit criteria 1- Absence of more than two sessions
Intervention groups: 1- The group tDCS(will be implemented for 10 sessions of 20 minutes for the intervention group) 2- Emotion regulation group(based on Gross protocol will be done for 8 sessions) 3-Sham group (20 seconds after turning the device, the stimulation will be stopped)
Main outcome variables: Reducing symptoms of depression

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20221214056816N3

Registration date: 2024-06-29, 1403/04/09

Registration timing: registered_while_recruiting

Last update: 2024-06-29, 1403/04/09

Update count: 0
Registration date: 2024-06-29, 1403/04/09

Registrant information: Name

zakaria eskandari

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 24 3315 6444

Email address

dreskandari@zums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2024-06-05, 1403/03/16
Expected recruitment end date: 2024-07-21, 1403/04/31
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the effectiveness of Transcranial direct current stimulation (tDCS) and treatment based on emotion regulation in improving executive functions and cognitive functions of students with major depression in Zanjan city in 1402: a double-blind clinical trial.

Public title: Comparing the effectiveness of Transcranial direct current stimulation (tDCS) and treatment based on emotion regulation in improving executive functions and cognitive functions of students with major depression.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Having the ability to give informed consent to participate in research Having major depressive disorder being a student Being at least 18 and at most 40 years old

Exclusion criteria:

Having other severe psychiatric disorders Not taking psychiatric drugs
Age: From 18 years old to 40 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Outcome assessor
Data analyser

Sample size

Target sample size: 68

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization is done through simple random method using coin toss. In this way, subjects are randomly assigned to treatment and control groups

Blinding (investigator's opinion)

Double blinded

Blinding description

After the initial evaluation of the subjects by the research associate, the subjects will be randomly placed in 4 groups by the supervisor (the participants will not be given information about how they will be assigned) in such a way that the main therapist of the project (executor Treatment protocol) research will not know about the type, manner, and allocation of people and how to do this. After the implementation of the treatment, re-evaluation will be done by the primary evaluator without him knowing in which treatment group،control, or sham group the client was.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee Unit of Islamic Azad University, Zanjan Branch

Street address

Zanjan - Student Blvd - Pain Kouh Land Road - Islamic Azad University, Zanjan branch

City

Zanjan

Province

Zanjan

Postal code

4515658145
Approval date: 2024-02-10, 1402/11/21
Ethics committee reference number: IR.IAU.Z.REC.1403.004

Health conditions studied

1

Description of health condition studied: depression
ICD-10 code: F32.1
ICD-10 code description: Major depressive disorder, single episode, moderate

Primary outcomes

1

Description: Beck's depression score
Timepoint: 45 day
Method of measurement: Beck's depression test

2

Description: Difficulty in emotion regulation test score
Timepoint: 45 day
Method of measurement: Difficulty in emotion regulation test

3

Description: Tower of Hanoi test score
Timepoint: 45 day
Method of measurement: Tower of Hanoi test

4

Description: Wisconsin test score
Timepoint: 45 day
Method of measurement: Wisconsin test

5

Description: Go No Go Test score
Timepoint: 45 day
Method of measurement: Go No Go Test

6

Description: continuous attention task test score
Timepoint: 45 day
Method of measurement: continuous attention task

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group 1:The way it is done is that the tDCS device has two carbon pads, one for stimulation or anode (typically red) and the other for inhibition or cathode (typically black) inside the sponge pad moistened with sodium chloride (to establish better conductivity). will be placed. The therapeutic program of Transcranial direct current stimulation (tDCS) for 10 sessions of 20 minutes for two groups with a current intensity of 2 mA; The first group will be DLPFC (dorsolateral prefrontal cortex) (left anodic/right cathodic), the second group will be Sham-tDCS, the method of this group will be that 20 seconds after turning on the tDCS device, the stimulation will be stopped, but the clients will They will not know about this. In terms of compliance with the principles of professional ethics, the above protocol will also be performed for the sham group after the treatment sessions.
Category: Treatment - Devices

2

Description: Intervention group 2. Emotion regulation treatment based on the Gross protocol developed in 2001 will be performed for 8 sessions.
Category: Treatment - Other

3

Description: Control group: The control group will not receive any intervention during the research, but due to ethical principles, they will receive intervention after the treatment.
Category: Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Shahid Beheshti Hospital

Full name of responsible person

Zakaria Eskandari

Street address

Zanjan University of Medical Sciences-Shahid Beheshti Hospital, Department of Addiction Studies

City

Zanjan

Province

Zanjan

Postal code

4513615788

Phone

+98 24 5224 4001

Email

Eskandari.Psychology@gmail.com

1

Sponsor: Name of organization / entity

Zanjan University of Medical Sciences

Full name of responsible person

Zakaria Eskandari

Street address

Gavazang Road

City

Zanjan

Province

Zanjan

Postal code

4513956184

Phone

+98 24 5224 4001

Email

info@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: 5
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

Zakaria Eskandari

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Psychology

Street address

Zanjan University of Medical Science,Beheshti Hospital, Addiction studies department

City

Zanjan

Province

Zanjan

Postal code

4513956184

Phone

+98 24 3315 6444

Fax

Email

dreskandari@zums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Zanjan University of Medical Sciences

Full name of responsible person

Zakaria Eskandari

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Psychology

Street address

Zanjan University of Medical Science,Beheshti Hospital, Addiction studies department

City

Zanjan

Province

Zanjan

Postal code

4513956184

Phone

+98 24 3315 6444

Fax

Email

dreskandari@zums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Zanjan University of Medical Sciences

Full name of responsible person

Zakaria Eskandari

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Psychology

Street address

Zanjan University of Medical Science,Beheshti Hospital, Addiction studies department

City

Zanjan

Province

Zanjan

Postal code

4513956184

Phone

+98 24 3315 6444

Fax

Email

dreskandari@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: Due to the confidentiality of each person's private data, the data is shared in the form of an article.
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: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: Data and statistical analysis are shared through the article.
When the data will become available and for how long: 2024
To whom data/document is available: Academic and scientific institutions
Under which criteria data/document could be used: citing the source
From where data/document is obtainable: It is uploaded on scientific sites
What processes are involved for a request to access data/document: Through correspondence with the project manager's email
Comments: After the data is ready, the data will be shared with the article

Comparison of the effectiveness of Transcranial direct current stimulation (tDCS) and treatment based on emotion regulation in improving executive functions and cognitive functions of students with major depression in Zanjan city in 1402: a double-blind clinical trial.