Protocol summary

Study aim
Determining the Efficacy of CBT-IA Therapy in Reducing Problematic Use of Social Networks in Users
Design
The clinical trial have a control group, with parallel groups, double-blind, randomized, on 30 patients. Individuals will be divided into two groups using restricted randomization method with random allocation rule.
Settings and conduct
After identifying problematic users of social networks using a standard deviation higher than the mean score in the adapted version of the Facebook Addiction Questionnaire and clinical interview, sample people are invited to the medical centers of the University of Social Welfare and Rehabilitation Sciences in Tehran. The informed consent form was received from the participants and then they will be randomly treated in two groups by a clinical psychologist. All people are evaluated before and after treatment.
Participants/Inclusion and exclusion criteria
Entry conditions: 1. Individuals aged 18 years and above. 2. A standard deviation above the mean in the adapted version of the Bergen Facebook Addiction Questionnaire and the diagnosis of PSNU based on a clinical interview. Non-entry conditions: 1. Having suicidal thoughts 2. High cut-off score on the Depression Anxiety Stress Scale-21 (DASS-21)
Intervention groups
Cognitive Behavioral Therapy for internet addiction : It consists of 12 weekly sessions. The initial focus is on behavioral techniques targeting specific behaviors and situations. In the second stage, the focus is more on cognitive assumptions and distortions, and its techniques include evaluating the type of cognitive distortions, problem solving skills, and teaching coping strategies. The final stage involves addressing underlying problems and comorbid disorders, if present.
Main outcome variables
Problematic use of social networks, Depression anxiety stress, Quality of life of users

General information

Reason for update
Acronym
CBT-IA & PSNU
IRCT registration information
IRCT registration number: IRCT20210422051043N1
Registration date: 2024-10-02, 1403/07/11
Registration timing: registered_while_recruiting

Last update: 2024-10-02, 1403/07/11
Update count: 0
Registration date
2024-10-02, 1403/07/11
Registrant information
Name
Afsane Yoosefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7708 2415
Email address
af.yoosefi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-03-15, 1403/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of cognitive behavioral therapy of Internet addiction in problematic social network users
Public title
Effect of cognitive behavioral therapy in social network addiction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being over 18 years old A standard deviation above the mean in the adapted version of the Bergen Facebook Addiction Questionnaire and the diagnosis of PSNU based on a clinical interview
Exclusion criteria:
Having suicidal thoughts High cut-off score on the Depression Anxiety Stress Scale-21 (DASS-21)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the classification of sample individuals into two treatment and control groups will be done using Restricted randomization method through random allocation rule in the following way: after selecting 30 sample,15 balls will be assigned to the control group and 15 balls to the treatment group, these balls will be placed in a lottery box and then randomly, without replacement, balls will be removed from the box and the sequence will be recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, all participants in the two treatment and control groups, the therapist who is responsible for pre-, during-, and post-treatment evaluations, and the data analyst are kept blind to the differences between the two treatment groups in terms of the type of interventions and which group each individual is assigned to.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of University of Social Welfare and Rehabilitation Sciences
Street address
No. 5, Unit 5, Amin Complex, Second Central Corner, 20 meters from the mosque, Ghanat Kosar
City
Tehran
Province
Tehran
Postal code
1689917466
Approval date
2021-08-25, 1400/06/03
Ethics committee reference number
IR.USWR.REC.1400.138

Health conditions studied

1

Description of health condition studied
Problematic use of social networks
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Reducing the total score in the adapted version of the Bergen Facebook Addiction Questionnaire to less than one standard deviation below the mean score
Timepoint
Before the start of therapeutic interventions and after the end of therapeutic interventions
Method of measurement
Bergen Facebook Addiction Scale

2

Description
Increase the quality of life above the cutoff point
Timepoint
Before starting therapeutic interventions and after the end of therapeutic interventions
Method of measurement
The World Health Organization quality of Life (WHOQOL-BREF) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group will undergo cognitive behavioral therapy for Internet addiction (CBT-IA). CBT-IA treatment introduced by Young et al. (2011) includes elements of traditional Cognitive Behavioral Therapy (CBT) and internet-related interventions to address internet addiction. This treatment is conducted over 12 weekly sessions, consisting of three phases: 1) behavioral modification 2) cognitive restructuring 3) harm reduction.
Category
Treatment - Other

2

Description
Control group: Control group: without therapeutic intervention. However, after completing the assessments, CBT-IA will be administered to the control group at 12 weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Social welfare and rehabilitation science
Full name of responsible person
Afsane Yoosefi
Street address
No. 5, Unit 5, Amin Complex, Second Central Corner, 20 meters from the mosque, Ghanat Kosar
City
Tehran
Province
Tehran
Postal code
1689917466
Phone
+98 912 795 8166
Email
yoosefi.afsan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Cognitive Sciences and Technologies Council
Full name of responsible person
Majid Nili Ahmadabadi
Street address
No. 3, third floor, Ostad Daryabandari Street (Armaghan Gharbi), above Niayesh Intersection, Vali Asr Street
City
Tehran
Province
Tehran
Postal code
۱۹۶۷۸۷۵۳۱۹
Phone
+98 21 6622 0770
Email
yoosefi.afsan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Cognitive Sciences and Technologies Council
Proportion provided by this source
50
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
Other

2

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Ghonche Raheb
Street address
Research Center for Substance Abuse and Dependency, third floor, Farabi Building, University of Rehabilitation Sciences and Social Health., Koodakiar Ave., Daneshju Boulevard., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2853
Email
sadrc@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
50
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Afsane Yoosefi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 5, Unit 5, Amin Complex, Second Central Corner, 20 meters from the mosque, Ghanat Kosar
City
Tehran
Province
Tehran
Postal code
1689917466
Phone
+98 21 7706 8825
Email
yoosefi.afsan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Afsane Yoosefi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 5, Unit 5, Amin Complex, Second Central Corner, 20 meters from the mosque, Ghanat Kosar
City
Tehran
Province
Tehran
Postal code
1689917466
Phone
+98 21 7706 8825
Email
yoosefi.afsan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Afsane Yoosefi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 5, Unit 5, Amin Complex, Second Central Corner, 20 meters from the mosque, Ghanat Kosar
City
Tehran
Province
Tehran
Postal code
1689917466
Phone
+98 21 7706 8825
Email
yoosefi.afsan@gmail.com

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data is presented in the form of individuals' scores in pre- and post-treatment assessments in both groups in a way that individuals' identities are unidentifiable, and it is provided in an Excel file.
When the data will become available and for how long
Access period begins 6 months after the publication of results and lasts for one year.
To whom data/document is available
Information is available for professionals, researchers, and therapists in the fields of psychology, psychiatry and cognitive sciences.
Under which criteria data/document could be used
Researchers in the field of addictive behavior under the following conditions: Keeping the data confidential and not disclosing it; Not using the data for writing scientific research articles or participating in scientific conferences
From where data/document is obtainable
Afsane Yoosefi. Email address: yoosefi.afsan@gmail.com
What processes are involved for a request to access data/document
درخواست هایی که از طریق ایمیل دریافت شده اند، توسط تیم پژوهشی مورد بررسی قرار می گیرند و درصورت تایید درخواست در مدت زمان 1تا2 هفته ارسال داده ها انجام خواهد شد.
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