Protocol summary
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Study aim
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Determining the effectiveness of an educational intervention based on transtheoretical model in treating of internet gaming disorder among adolescents in Abyek
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Design
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This study is randomly divided into parallel groups, two intervention and control groups with a sample size of 206 people.Out of 25 schools, 8 schools will be selected and 4 schools will be selected in the intervention group and 4 schools will be selected in the control group and then 30 people from each random school will be selected.
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Settings and conduct
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First,Abyek high school students will be sent an online questionnaire about internet gaming disorder and the insomnia severity index through social media.People with a score above 45 are randomly assigned to two intervention and control groups,the intervention group of the designed educational application receives the treatment of internet gaming disorder.The control group is trained on sleep hygiene.Before, one and three months after the end of the training, the questionnaires will be answered online again to evaluate the impact of the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:The desire to participate in the study;diagnosis of internet gaming disorder among students through the relevant questionnaire;access to computer, tablet or smartphone
exclusion criteria:age over 18 years;non-addiction to online games
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Intervention groups
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Based on the transtheoretical model and cognitive-behavioral therapy, the educational application intervention group receives 30 to 45 minutes in eight sessions in an educational package,control group training is about sleep hygiene.To assess the impact of the intervention, individuals fill out questionnaires in the app one and three months after the end of the training.
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Main outcome variables
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Online play time;Online game addiction score
General information
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Reason for update
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Due to changes in general health conditions and due to coronavirus disease, the sampling time of the study has changed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181226042140N1
Registration date:
2020-06-10, 1399/03/21
Registration timing:
prospective
Last update:
2020-08-25, 1399/06/04
Update count:
1
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Registration date
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2020-06-10, 1399/03/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-04-09, 1400/01/20
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Expected recruitment end date
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2021-06-10, 1400/03/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of an educational intervention based on transtheoretical model in treating of internet gaming disorder among adolescents in Abyek city
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Public title
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The effect of intervention of internet gaming disorder among adolescents
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Satisfaction to participate in research
Busy studying
Diagnosis of internet gaming disorder in students through the internet gaming disorder scale–short-form
Internet access
Access to computer, laptop, tablet or smartphone
Gain a score of 45 or higher on the evaluation of the initial questionnaire on internet gaming disorder
Ability to answer questionnaire questions
Lack of mental illness (such as schizophrenia and bipolar disorder) or mental disability
Exclusion criteria:
Age over 18 years
Non-addiction to online games
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Age
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From 12 years old to 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
206
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This research is a randomized trial study of a single blind.By simple randomization, out of a total of 25 schools, 8 schools are randomly selected.Out of 8 schools, 4 are randomly assigned to control groups and 4 to random experimental groups.From each school, 30 students will be randomly selected.From each school,the number of students selected will receive a special code through the SPSS software,and then,after analyzing the data,they will be randomly selected through this codes.
In each selected cluster, all students who played video games are selected.Subjects will be randomly divided into intervention and control groups.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Due to changes in general health conditions and due to coronavirus disease, the sampling time of the study has changed.
Ethics committees
1
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Ethics committee
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Approval date
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2020-02-26, 1398/12/07
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Ethics committee reference number
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IR.QUMS.REC.1398.358
Health conditions studied
1
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Description of health condition studied
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Internet gaming disorder
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ICD-10 code
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DSM-5
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ICD-10 code description
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Internet gaming disorder
Primary outcomes
1
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Description
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Online game addiction score
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Timepoint
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Before the intervention and 1 and 3 months after the start of the intervention
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Method of measurement
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Internet Gaming Disorder Scale–Short-Form
Secondary outcomes
1
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Description
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Insomnia Severity Index
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Timepoint
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To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins.
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Method of measurement
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Insomnia Severity Index (ISI)
2
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Description
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Scores of stress, anxiety, depression
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Timepoint
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To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins.
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Method of measurement
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Depression Anxiety Stress Scales (DASS)
3
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Description
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Recognize the individual's position in the cycle of stages of change
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Timepoint
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To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins.
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Method of measurement
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Questionnaire of Structural Stage of change of Transtheoretical Model
4
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Description
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Self-efficacy score
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Timepoint
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To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins.
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Method of measurement
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Questionnaire of Structural Self-Efficacy of Transtheoretical Model
5
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Description
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Decision Balance Score
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Timepoint
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To evaluate participants, they answer the questionnaire questions before the intervention, one and three months after the intervention begins.
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Method of measurement
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Questionnaire of Structural Decision Balance of Transtheoretical Model
Intervention groups
1
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Description
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Intervention group: The educational application is designed based on the transtheoretical model and cognitive-behavioral therapy.The tutorials are designed for 8 sessions of 30 to 45 minutes.The content of the sessions includes increasing awareness and investigating the effect of internet gaming on people's physical and mental health; It is also about identifying misconceptions about online games and it also identifies and corrects misconceptions about online games.Part of this training also includes self-control, coping responses, and overcoming temptation.
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Category
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Behavior
2
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Description
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Control group: Online educational sessions are designed in 8 sessions, 30 minutes with the topic of sleep hygiene.The content of the sessions is designed to increase knowledge and improve sleep hygiene behavior,sleep habits,sleep management,identify incorrect patterns of behavior associated with sleep,and the impact of the environment, time, physical activity and nutrition on people's sleep.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Qazvin University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available