Protocol summary

Study aim
Determining the effectiveness of cognitive behavioral therapy in reducing internet addiction, sleep quality, and mental health
Design
This study is designed as a randomized clinical trial with two parallel groups (15 participants). The experimental group will receive a structured CBT intervention, the control group will receive no intervention. Participant allocation will be done by block randomization (block size 4) and through sealed envelopes.
Settings and conduct
This study is a clinical trial conducted on students of Ahvaz Azad University. The samples are randomly divided into two intervention groups (receiving CBT) and control, and data are collected with standard questionnaires. The outcome assessor is blinded to the grouping of the samples to avoid bias.
Participants/Inclusion and exclusion criteria
Entry requirements: Be Iranian and resident of Ahvaz city, be a student, have a smartphone, have at least one year of creating an account on social networks such as Instagram, etc., age 18 to 25 years. Exclusion criteria: Be under psychiatric treatment due to mental health problems, be addicted to drugs, psychotropic drugs, alcohol, or abuse medication.
Intervention groups
Intervention group (experiment): This group will receive a cognitive-behavioral therapy (CBT) intervention protocol specifically designed to reduce Internet addiction. The intervention will consist of structured sessions (e.g., 8 to 10 weekly 90-minute sessions) that cover topics such as time management, identifying cognitive distortions, improving communication skills, and emotion regulation. Control group: This group will not receive any active intervention during the study period.
Main outcome variables
Internet addiction, sleep quality, mental health

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250611066182N1
Registration date: 2025-09-05, 1404/06/14
Registration timing: prospective

Last update: 2025-09-05, 1404/06/14
Update count: 0
Registration date
2025-09-05, 1404/06/14
Registrant information
Name
Nahid Saeedinasb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4352 1611
Email address
nahid.saeedinasb@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-21, 1404/06/30
Expected recruitment end date
2026-03-21, 1405/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of cognitive behavioral therapy in reducing internet addiction, sleep quality, and mental health among students of Islamic Azad University of Ahvaz Branch.
Public title
Cognitive behavioral therapy in reducing internet addiction, sleep quality, and mental health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be Iranian and a resident of Ahvaz city Be a student Have a smartphone Have at least one year of creating an account on social networks such as Instagram, etc. Be between 18 and 25 years of age.
Exclusion criteria:
Addiction to narcotics, psychotropic substances, alcohol, or medication abuse Are under psychiatric treatment due to mental health problems
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
This study used a block randomization method with a block size of 4. The sequence of group allocation (experimental/control) was generated using Excel software and protected in sealed envelopes. After screening and obtaining consent, participants were assigned to groups based on the order of arrival and opening of the envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, due to the non-blinded nature of the intervention (cognitive-behavioral therapy), only the Outcome Assessor and Data Analyst will be blinded. After random assignment of participants to the experimental and control groups, the assessor, who is responsible for collecting post-test and follow-up data, will not be aware of the purpose of the study and the type of group assignment of the participants. The data will be provided to him/her in coded form (without group identifiers). Also, the data analyst will perform statistical analysis without knowing the grouping of the samples to avoid any bias.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Ahvaz
Street address
Islamic Azad University, Ahvaz Branch, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Approval date
2025-06-07, 1404/03/17
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.165

Health conditions studied

1

Description of health condition studied
Internet addiction
ICD-10 code
F51.9
ICD-10 code description
Sleep disorder not due to a substance or known physiological condition, unspecified

Primary outcomes

1

Description
Internet addiction
Timepoint
Pretest (before the intervention), posttest (immediately after the intervention), and follow-up (at least 2 months after the intervention).
Method of measurement
Young's Internet Addiction Questionnaire

Secondary outcomes

1

Description
Sleep quality
Timepoint
Pre-test (before the intervention), post-test (immediately after the completion of the 8-week intervention), and follow-up (2 months after the completion of the intervention).
Method of measurement
Pittsburgh Standardized Sleep Quality Questionnaire

2

Description
Mental health
Timepoint
Pre-test (before the intervention), post-test (immediately after the completion of the 8-week intervention), and follow-up (2 months after the completion of the intervention).
Method of measurement
Standardized General Health Questionnaire

Intervention groups

1

Description
Intervention group: 15 eligible students will receive a structured cognitive-behavioral therapy (CBT) protocol. The intervention will consist of 8 90-minute sessions (one session per week) with educational content and practical exercises to manage internet addiction, improve sleep quality, and improve mental health.
Category
N/A

2

Description
Control group: Fifteen eligible students who do not receive any active intervention and will only be assessed at pre-test, post-test, and follow-up will be included. In order to comply with ethical considerations, if the intervention is effective, similar training will be provided to this group after the study is completed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Ahvaz Branch
Full name of responsible person
Narges Heydarianfar
Street address
Islamic Azad University, Ahvaz Branch, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8421
Email
info@iauahvaz.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pejman Taghipour Birgani
Street address
Islamic Azad University, Ahvaz Branch, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8421
Email
info@iauahvaz.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Narges Heydarianfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Ahvaz Branch, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8421
Email
info@iauahvaz.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Narges Heydarianfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Ahvaz Branch, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8421
Email
info@iauahvaz.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nahid Saeedinasb
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 17, Second North Alley, West Mehdi Street, Chevil Street
City
Izeh
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 4352 1611
Fax
Email
info@iauahvaz.ac.ir

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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