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Comparing the effectiveness of cognitive-behavioral therapy and transcranial direct current stimulation(tDCS) in reducing symptoms and improving the executive functions of students with Internet addiction

Protocol summary

Study aim
Determining the effectiveness of cognitive-behavioral therapy specific to Internet addiction and transcranial direct current stimulation (tDCS) in reducing symptoms and improving executive functions of students with Internet addiction.
Design
The clinical trial will have a control group, a sham group in parallel, randomized, on 40 people. For randomization, the computer program will be used.
Settings and conduct
Students who are addicted to the Internet and who refer to Shahid Beheshti Hospital in Zanjan during the study will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups. This study will be conducted in a double-blind manner.
Participants/Inclusion and exclusion criteria
The inclusion criteria: informed consent and voluntarily participating; age at least 18 and at maximum 38 years old; diagnosed case for internet addiction. The exclusion criteria: depression, schizophrenia, other psychotic disorders, obsessive-compulsive disorder, bipolar disorder, anxiety disorders, etc.; receiving psychiatric drugs; receiving psychological treatments.
Intervention groups
Intervention group 1: cognitive behavioral therapy will be performed based on the treatment protocol, cognitive-behavioral therapy specific to Internet addiction, recognizing dysfunctional feelings and actions, social and behavioral defects, motivation, and creating behaviors replaces Intervention group 2:tDCS, this device is a brand name Activadose, which is manufactured in Canada. Intervention group 3: sham for tdcs, same as group 2 but without brain stimulation Intervention group 4: while no intervention is performed on the research community.
Main outcome variables
Internet addiction; Executive functions; Cognitive abilities ; Excitement regulation ; Impulsiveness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221214056816N2
Registration date: 2023-10-25, 1402/08/03
Registration timing: registered_while_recruiting

Last update: 2023-10-25, 1402/08/03
Update count: 0
Registration date
2023-10-25, 1402/08/03
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
2023-05-22, 1402/03/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of cognitive-behavioral therapy and transcranial direct current stimulation(tDCS) in reducing symptoms and improving the executive functions of students with Internet addiction
Public title
Investigating cognitive-behavioral therapy and direct current brain stimulation (tDCS) in Internet addiction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent and voluntary participation in internet addiction treatment sessions Being at least 18 and at most 38 years old Being a student Being diagnosed with internet addiction
Exclusion criteria:
Having other psychiatric disorders such as depression, schizophrenia, other psychotic disorders, obsessive disorders, bipolar disorder, anxiety disorders, etc. Receiving psychiatric drugs Receiving psychological treatments
Age
From 18 years old to 38 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The initial samples will be available as sampling, and then according to the screening tools, those who have been diagnosed with Internet addiction will be selected through simple randomization using computer programs from the table of random numbers to be assigned to sham and treatment groups. became. In this method, all members of the community have an equal chance to be elected. To use the table of random numbers, the researcher first defines the framework of his statistical society; and gives them a code or machine gun number respectively so that the samples can be selected.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, SHahrak town, Mahdavi Blvd.,
City
zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.ZUMS.REC.1401.390

Health conditions studied

1

Description of health condition studied
Internet addiction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Young's Internet Addiction Questionnaire score
Timepoint
Pre-test, before the intervention - post-test, 1 week after the intervention - follow-up, 3 months after the intervention
Method of measurement
Young Internet Addiction Questionnaire

2

Description
Nejati Cognitive Abilities Questionnaire score
Timepoint
Pre-test, before the intervention - post-test, 1 week after the intervention - follow-up, 3 months after the intervention
Method of measurement
Nejati Cognitive Abilities Questionnaire

3

Description
Gertz and Roemer's Emotion Regulation Difficulty Questionnaire score
Timepoint
Pre-test, before the intervention - post-test, 1 week after the intervention - follow-up, 3 months after the intervention
Method of measurement
Roemer's Emotion Regulation Difficulty Questionnaire

4

Description
Bart's Impulsivity Questionnaire score
Timepoint
Pre-test, before the intervention - post-test, 1 week after the intervention - follow-up, 3 months after the intervention
Method of measurement
Barrett's Impulsivity Test

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: cognitive-behavioral therapy specific to Internet addiction, deals with recognizing dysfunctional feelings and actions, social and behavioral defects, motivation, and creating alternative behaviors, which includes twelve weekly sessions and a six-month follow-up.
Category
Treatment - Other

2

Description
The second intervention group: transcranial direct current stimulation by the Actiodose device made in Canada, which is a non-invasive, painless and tolerable brain stimulation technique that is able to change the activation of the cerebral cortex and a weak direct current through surface electrodes on the scalp. It applies this weak and direct current through the connection of two electrodes, anode and cathode, at different points on the surface of the skull, leading to an increase and decrease in the stimulation of the underlying neurons. This treatment will be 12 sessions of 20 minutes.
Category
Treatment - Devices

3

Description
Sham group: Electrodes will be placed on their skulls, but no brain stimulation will take place. This treatment will be 12 sessions of 20 minutes by tDCS actiodose device made in Canada.
Category
Placebo

4

Description
Control group: No treatment is performed and only evaluations are performed
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Specialized Medical Training Center
Full name of responsible person
Zakaria Eskandari, Zanjan University of Medical Sciences, Zanjan University
Street address
Shahid Beheshti Specialized and Subspecialized Medical Training Center, Above Arg Square ,Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
beheshti @zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Nedri
Street address
Zanjan University of Medical Sciences, Dr. Youssef Soubouti Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3354 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
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
Mehdi khani
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Specialized and Subspecialized Medical Training Center - Above Arg Square -Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3354 4001
Email
m.xani1990@gmail.com

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
Addiction studies department, Beheshti Hospital, Zanjan University of Medical Science, Znjan
City
Zanjan
Province
Zanjan
Postal code
4513615788
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
Mehdi khani
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti hospital Medical Training Center, Above Arg Square - Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3354 4001
Email
m.xani1990@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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