Protocol summary

Study aim
Determining the effectiveness of acceptance and commitment group therapy on anxiety, internet aggression and social isolation in teenagers with internet addiction
Design
Clinical trial with control group, with Factorial groups, double-blind, randomized, phase 2 on 40 patients, rand function of Excel software was used for randomization.
Settings and conduct
In order to conduct the research, the researcher will go to Kashan schools (girls and boys) with a written letter of introduction from Kashan University of Medical Sciences. Then, people who meet the entry criteria are randomly assigned to two treatment groups based on acceptance and commitment (ACT) and the control group. In the pre-test phase, all participants will complete questionnaires on Internet addiction, technology anxiety, Internet aggression, and social isolation.
Participants/Inclusion and exclusion criteria
-Conditions for entering the study: receiving a score of more than 46 in the Internet Addiction Questionnaire, Minimum age of 12 and maximum of 17, -Exclusion criteria: No response to more than 5% of the research questions, Lack of the motivation and consent to participate in the research
Intervention groups
The intervention group will receive acceptance and commitment group therapy for 8 sessions of 45 minutes. The control group will not receive treatment during this period, but in order to comply with professional ethics, after the completion of the follow-up phase, the participants in the control group will also receive ACT treatment
Main outcome variables
Anxiety, Internet aggression, social isolation, Internet addiction

General information

Reason for update
Acronym
ACT
IRCT registration information
IRCT registration number: IRCT20240906062958N1
Registration date: 2024-09-11, 1403/06/21
Registration timing: prospective

Last update: 2024-09-11, 1403/06/21
Update count: 0
Registration date
2024-09-11, 1403/06/21
Registrant information
Name
Reyhaneh Sadat Ghazanfary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3231 3242
Email address
reyhansadatghazanfary@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-26, 1403/07/05
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Group Acceptance and Commitment Therapy on Anxiety, Internet Aggression and Social Isolation in Adolescent with Internet Addition
Public title
The Effectiveness of Group Acceptance and Commitment Therapy On Internet Addition
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
To receive a score of more than 46 in the internet addiction questionnaire Minimum age is 12 and maximum age is 17 Having the physical ability to perform the exercises that are determined in each session Absence of mental disorders requiring immediate treatment, such as drug and alcohol abuse disorders, psychotic disorders, depression disorders Non-receipt Psychological interventions during the last year and related drug treatment at least one month before the baseline measurement phase
Exclusion criteria:
No response to more than 5% of research questions Lack of motivation and satisfaction to participate in the research The occurrence of unfortunate events such as the loss of loved ones for a person The person's unwillingness to continue the treatment Absence for two sessions in treatment Occurrence of stress caused by exams or any other issue causing tension and stress Having to mental disorder that requires immediate treatment, such as drug and alcohol use disorder, psychotic disorders, and depression Thinking about harming or killing yourself Lack of physical ability to perform the exercises that are determined in each session (for example: having a lot of pain) Simultaneous participation in another treatment program
Age
From 12 years old to 17 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
In order to conduct the research, the researcher refers to Kashan schools (girls and boys) with a written introduction letter from Kashan University of Medical Sciences. Adolescents who complete the internet addiction questionnaire and have internet addiction and meet the entry criteria are randomly selected in a stratified manner. In the first visit of the researcher, in order to comply with the ethical principles, information about the research was given to the participants (the number of meetings, the duration of each meeting, the way the meeting was held, etc.) and the right to withdraw from the research is provided. At any time, their consent will be obtained to participate in the research. Then, people who meet the inclusion criteria are randomly assigned to two treatment groups based on acceptance and commitment (ACT) and the control group. In the pre-test phase, all participants will complete questionnaires on Internet addiction, technology anxiety, Internet aggression, and social isolation. In order to eliminate the effect of the order of the questionnaires and to control the effect of the subjects' fatigue in answering the questions, a balance is made, so that the order of the questionnaires is changed randomly in all participants. It is also possible for them to answer questions twice. After completing the research tools in the pre-test stage, the ACT group patients will participate in 8 45-minute group therapy sessions weekly based on the treatment protocol, while the control group participants will not receive any treatment during this period. . , but in order to comply with ethical considerations, they will only receive psychological training unrelated to treatment (such as critical thinking training). After the treatment sessions are over, the above questionnaires will be administered again. Also, to check the durability of the effects of the treatment intervention, the participants of both groups, two months after the completion of the treatment and in the follow-up phase, will answer all the research tools again, and finally, the collected data will be analyzed and is analyzed. Also, in order to comply with professional ethics, after the completion of the follow-up phase, the participants in the control group will also undergo ACT treatment. It should be noted that the therapist is trained in the field of therapy based on acceptance and commitment. In addition, treatment sessions will be held under the supervision and advice of supervisors and consultants specializing in this treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Unit 15, Block 8, Hasht Behesht Building, Mutalefe 1 Alley, Abu Talib street., Pardisan, Qom
City
Ghoum
Province
Ghoum
Postal code
3711353139
Approval date
2024-07-14, 1403/04/24
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1403.079

Health conditions studied

1

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

Primary outcomes

1

Description
Internet addiction score in Young's Internet Addiction Questionnaire
Timepoint
Measuring internet addiction, anxiety, internet aggression and social isolation at the beginning of the study (before the start of the intervention) and 2 months later (in the follow-up phase)
Method of measurement
Kimberly Young Internet Addiction Questionnaire - Beck Anxiety Questionnaire - Alvarez, Garcia et al. Cyber ​​Aggression Questionnaire - Russell et al. Loneliness Questionnaire

Secondary outcomes

1

Description
Anxiety score in Beck Anxiety Questionnaire
Timepoint
Anxiety score at the beginning of the study (before the intervention) and 2 months later (in the follow-up phase)
Method of measurement
Beck's 21-question anxiety questionnaire

Intervention groups

1

Description
Intervention group: Intervention group: includes control group and intervention group. The intervention group will receive treatment based on acceptance and commitment in 8 sessions of 45 minutes, and the control group will not receive treatment during this time. But in order to comply with ethical considerations after the end of the treatment, acceptance and commitment therapy or a type of psychological training will also be implemented for the control group if the members of the control group wish.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Schools of Kashan city
Full name of responsible person
Dr.Hamid Amiri
Street address
Hasht Behesht Complex, 1 Mutalefe Alley, Pardisan, Qom
City
Ghoum
Province
Ghoum
Postal code
3711353139
Phone
+98 25 3231 3242
Email
reyhansadatghazanfary@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Hamid Amiri
Street address
Hasht Behesht Complex, 1 Mutalefe Alley, Pardisan, Qom
City
Ghoum
Province
Ghoum
Postal code
3711353139
Phone
+98 25 3231 3242
Email
reyhansadatghazanfary@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr.Hamid Amiri
Position
Master's student in clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Hasht Behesht Complex, 1 Mutalefe Alley, Pardisan, Qom
City
Ghoum
Province
Ghoum
Postal code
3711353139
Phone
+98 25 3231 3242
Email
reyhansadatghazanfary@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Hamid Amiri
Position
Master's student in clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Hasht Behesht Complex, 1 Mutalefe Alley, Pardisan, Qom
City
Ghoum
Province
Ghoum
Postal code
3711353139
Phone
+98 25 3231 3242
Email
reyhansadatghazanfary@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Reyhan sadat Ghazanfary
Position
Master's student in clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Hasht Behesht Complex, 1 Mutalefe Alley, Pardisan, Qom
City
Ghoum
Province
Ghoum
Postal code
3711353139
Phone
+98 25 3231 3242
Fax
Email
reyhansadatghazanfary@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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